Study to Evaluate Safety and Efficacy of Dapagliflozin an... | NCT03199053 | Trialant
NCT03199053
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Jun 21, 2024Actual
Enrollment
256Actual
Phase
Phase 3
Conditions
Diabetes Mellitus, Type 2
Interventions
Dapagliflozin
Saxagliptin
Placebo
Countries
United States
Argentina
Australia
Brazil
Canada
Chile
Colombia
Finland
India
Israel
Italy
Malaysia
Mexico
New Zealand
Philippines
Poland
Russia
South Korea
Taiwan
Thailand
Turkey (Türkiye)
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03199053
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D1680C00019
Secondary IDs
ID
Type
Description
Link
2015-005042-66
EudraCT Number
Brief Title
Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old
Official Title
A 26 Week, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Trial With a 26 Week Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 5 and 10 mg, and Saxagliptin 2.5 and 5 mg in Pediatric Patients With Type 2 Diabetes Mellitus Who Are Between 10 and Below 18 Years of Age
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
May 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 11, 2017Actual
Primary Completion Date
Feb 1, 2023Actual
Completion Date
Jan 3, 2024Actual
First Submitted Date
Jun 22, 2017
First Submission Date that Met QC Criteria
Jun 23, 2017
First Posted Date
Jun 26, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jan 31, 2024
Results First Submitted that Met QC Criteria
Mar 20, 2024
Results First Posted Date
Apr 17, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 28, 2024
Last Update Posted Date
Jun 21, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objective of this study is to determine if there will be a greater mean reduction from baseline in glycated hemoglobin (HbA1c) achieved after 26 weeks of oral double-blind add-on therapy of dapagliflozin or saxagliptin compared to placebo in paediatric T2DM patients with HbA1c levels of 6.5 to 10.5% on diet and exercise and metformin, insulin, or metformin plus insulin.
Detailed Description
Not provided
Conditions Module
Conditions
Diabetes Mellitus, Type 2
Keywords
Type 2 Diabetes Mellitus
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
256Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Low dose Dapagliflozin
Experimental
Oral route. Start with a low dose of dapagliflozin administered once daily and remain on the low dose regardless of your HbA1c at week 12.
Drug: Dapagliflozin
Low dose/high dose Dapagliflozin
Experimental
Oral route. Start with a low dose of Dapagliflozin administered once daily and up titrate to the high dose Dapagliflozin administered once daily if HbA1c >= 7% at week 12
Drug: Dapagliflozin
Low dose Saxagliptin
Experimental
Oral route. Start with a low dose of saxagliptin administered once daily and remain on the low dose regardless of your HbA1c at week 12
Drug: Saxagliptin
Low dose/high dose Saxagliptin
Experimental
Oral route. Start with a low dose of saxagliptin administered once daily and up titrate to the high dose if HbA1c >= 7% at week 12
Drug: Saxagliptin
Placebo arm
Placebo Comparator
Oral route. Placebo tablets administered for 52 weeks
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Dapagliflozin
Drug
Tablets, Oral, 5mg , Once daily Tablets, Oral, 10mg, Once daily
Low dose Dapagliflozin
Low dose/high dose Dapagliflozin
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on multiple imputation washout (MI-WO) within each arm using the data from placebo participants with Week 26 data.
Baseline and Week 26
Saxagliptin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Baseline and Week 26
Secondary Outcomes
Measure
Description
Time Frame
Dapagliflozin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Signed Written Informed Consent
Target Population
Previously diagnosed with Type 2 Diabetes Mellitus by World Health Organization/ADA criteria
HbA1c between 6.5% and 10.5% obtained at screening.
Currently on diet and exercise and stable dose of at least 1000 mg metformin (IR or XR) for a minimum of 8 weeks, or stable dose of insulin for a minimum of 8 weeks, or a stable combination of at least 1000 mg metformin (IR or XR) and insulin for a minimum of 8 weeks prior to randomization. For those children on insulin, investigators will confirm that attempts at removing insulin from the subject's therapeutic regimen had been previously made but had not been successful.
Age and Reproductive Status
Male and female patients eligible if 10 years of age, up to but not including 18 years of age at the time of enrollment/screening. At least 30% of total subjects will be between the ages of 10 and 14 years and at least one third, but no more than two thirds, female subjects.
Women of childbearing potential must have a negative pregnancy test within 24 hours prior to the start of study drug.
Women must not be breastfeeding.
Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs: saxagliptin, and dapagliflozin, plus 5 half-lives of study drugs or 30 days (whichever is longer), plus 30 days (duration of ovulatory cycle) for a total of 60 days post treatment completion.
Exclusion Criteria:
Target Disease Exceptions
Presence of Type 1 diabetes, as demonstrated by Preexisting diagnosis of Type 1 diabetes,
Previous diagnosis of monogenic etiology of Type 2 diabetes
Diabetes ketoacidosis (DKA) within 6 months of screening
Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the main study:
Eight weeks: sulfonylureas, alpha glucosidase inhibitors, metiglinide, oral or injectable incretins or incretin mimetics, other antidiabetes medications not otherwise specified.
Sixteen weeks: thiazolidinediones, DPP-4 inhibitors (with no reported medication related AEs related to DPP-4 inhibitors), sodium glucose cotransporter-2 (SGLT-2) inhibitors (with no reported medication related AEs related to SGLT-2 inhibitors)
Initiation or discontinuation of prescription or non-prescription weight loss drugs within 8 weeks of screening. Use of prescription or non-prescription weight loss drugs must be stable during the study.
Medical History and Concurrent Diseases
Pregnant, positive serum pregnancy test, planning to become pregnant during the clinical trials, or breastfeeding
History of unstable or rapidly progressive renal disease
History of unresolved vesico-ureteral reflux
History of or current, acute or chronic pancreatitis
History of hemoglobinopathy, with the exception of sickle cell trait or thalassemia minor; or chronic or recurrent hemolysis
Malignancy within 5 years of the screening visit (with the exception of treated basal cell or treated squamous cell carcinoma)
Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for > 4 weeks within 3 months prior to the Day 1 visit
Physical and Laboratory Test Findings
Abnormal renal function,
An abnormal thyroid-stimulating hormone (TSH) value at enrollment will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded.
Hematuria (confirmed by microscopy at screening) with no explanation as judged by the Investigator up to randomization.
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2× upper limit of normal (ULN), or clinically significant hepatic disease.
Serum total bilirubin (TB) > 2x ULN unless exclusively caused by Gilbert's syndrome
Positive serologic evidence of current infectious liver disease including anti hepatitis A virus (HAV) (IgM), hepatitis B surface antigen (HBsAg), or anti hepatitis C virus (HCV). Patients who have isolated positive anti-hepatitis B surface antibodies may be included.
Anemia of any etiology
Volume-depleted subjects.
Allergies and Adverse Drug Reaction
Known allergy, sensitivity or contraindication to any study drug or its excipient/vehicle
Other Exclusion Criteria
Subject is currently abusing alcohol or other drugs or has done so within the last 6 months prior to the screening visit.
Prisoners or subjects who are involuntarily incarcerated. (Note: under certain specific circumstances a person who has been imprisoned may be included or permitted to continue as a subject. Strict conditions apply and Sponsor/designee approval is required.)
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
Psychiatric or cognitive disorder that will, in the opinion of investigators, limit the subject's ability to comply with the study medications and monitoring.
Subjects who have contraindications to therapy as outlined in the saxagliptin and dapagliflozin Investigator Brochure or local package inserts.
Participation and receiving IP in another clinical study during the prior 3 months
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
An initial 26-week short-term (ST) period was followed by a 26-week long-term (LT) safety extension period. The study drug was discontinued at Week 52, after which participants continued in the Non-treatment Follow-up Period until Week 104.
Of the 256 participants enrolled, 11 were excluded from analysis due to GCP considerations at the site they originated from (see limitations and caveats for further details).
Recruitment Details
A total of 245 patients were randomised from 94 sites in 21 countries. Participants were initially randomised in a 1:1:1 ratio to receive dapagliflozin 5 mg, saxagliptin 2.5 mg, or placebo.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Dapagliflozin
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 glycated haemoglobin (HbA1c) values < 7% remained on low-dose dapagliflozin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of dapagliflozin.
Periods
Title
Milestones
Reasons Not Completed
ST Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 7, 2022
Jan 31, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
China
Romania
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Eligible subjects with HbA1c of 6.5% to 10.5% at screening will be randomized 1:1:1 to receive dapagliflozin 5 mg, saxagliptin 2.5 mg, or placebo. Blinded HbA1c assessment will be performed at Week 12. All subjects with Week 12 HbA1c < 7% will remain on previously assigned randomized treatment. Subjects taking dapagliflozin with Week 12 HbA1c ≥ 7% will be re-randomized in a 1:1 ratio to continue on the low-dose treatment (dapagliflozin 5 mg) or up titrate to the high-dose treatment (dapagliflozin 10 mg). Subjects taking saxagliptin with Week 12 HbA1c ≥ 7% will be re-randomized in a 1:1 ratio to continue on the low-dose treatment (saxagliptin 2.5 mg) or up-titrate to the high-dose treatment (saxagliptin 5 mg). Subjects taking placebo with Week 12 HbA1c ≥ 7% will continue on placebo treatment. All placebo subjects and all subjects taking saxagliptin or dapagliflozin with HbA1c < 7% at Week 12 will go through a dummy 2nd randomization process for maintaining the blinding.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
sponsor
Who Masked
ParticipantInvestigator
Forxiga
Saxagliptin
Drug
Tablets, Oral, 2.5mg Once daily Tablets, Oral, 5mg, Once daily
Low dose Saxagliptin
Low dose/high dose Saxagliptin
Onglyza
Placebo
Drug
Matching placebo to dapagliflozin 5mg and 10 mg/saxagliptin 2.5 mg and 5 mg, Tablets, oral, Once daily
Placebo arm
Baseline and Week 26
Saxagliptin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Baseline and Week 26
Dapagliflozin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Baseline and Week 26
Saxagliptin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Baseline and Week 26
Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Baseline and Week 26
Saxagliptin Versus Placebo: Adjusted Mean Change From Baseline in FPG at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Baseline and Week 26
Dapagliflozin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Baseline and Week 26
Saxagliptin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Baseline and Week 26
Dapagliflozin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Baseline and Week 26
Saxagliptin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Baseline and Week 26
Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26
A logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Baseline and Week 26
Low-dose/High-dose Versus Placebo (Weighted): Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26
A weighted logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Baseline and Week 26
Low-dose Versus Placebo (Weighted): Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26
A weighted logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Baseline and Week 26
Low-dose Versus Uptitration to the High Dose: Adjusted Mean Change From Baseline in HbA1c at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Baseline and Week 26
Low-dose Versus Uptitration to the High Dose: Adjusted Mean Change From Baseline in FPG at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Baseline and Week 26
Dapagliflozin Low-dose Versus Uptitration to the High Dose: Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26
A Fisher's exact test was used and unadjusted difference in percentage of participants and Clopper-Pearson CIs presented using imputed data. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Baseline and Week 26
Saxagliptin Low-dose Versus Uptitration to the High Dose: Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26
A Fisher's exact test was used and unadjusted difference in percentage of participants and Clopper-Pearson CIs presented using imputed data. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of saxagliptin.
FG002
Placebo
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
At either Week 32 or Week 40 eligible participants receiving placebo (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.
FG00081 subjects
FG00188 subjects
FG00276 subjects
Week 14 no Uptitration Randomisation
Excluded from Uptitration Randomised Participants Data Set.
FG00039 subjects
FG00136 subjects
FG0020 subjects
Week 14 Uptitration Randomisation
Included in Uptitration Randomised Participants Data Set.
FG00042 subjects
FG00152 subjects
FG0020 subjects
COMPLETED
FG00076 subjects
FG00183 subjects
FG00268 subjects
NOT COMPLETED
FG0005 subjects
FG0015 subjects
FG0028 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0014 subjects
FG0026 subjects
Withdrawal by parent/guardian
FG0001 subjects
FG0011 subjects
FG0021 subjects
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0021 subjects
LT Period
Type
Comment
Milestone Data
STARTED
FG00076 subjects
FG00183 subjects
FG00268 subjects
Randomised Withdrawal Patients Data Set
FG00013 subjects
FG00125 subjects
FG0028 subjects
Excluded From Randomised Withdrawal Patients Data Set
FG00068 subjects
FG00163 subjects
FG00268 subjects
Randomised to Continue Metformin
Pre-specified in the statistical analysis plan, only participants who continued or discontinued metformin after the third randomization were collected.
FG0006 subjects
FG00112 subjects
FG0022 subjects
Randomised Metformin Withdrawal
Pre-specified in the statistical analysis plan, only participants who continued or discontinued metformin after the third randomization were collected.
FG0007 subjects
FG00113 subjects
FG0026 subjects
COMPLETED
FG00075 subjects
FG00179 subjects
FG00261 subjects
NOT COMPLETED
FG0001 subjects
FG0014 subjects
FG0027 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0013 subjects
FG0023 subjects
Withdrawal by parent/guardian
FG000
Non-treatment Follow-up Period
Type
Comment
Milestone Data
STARTED
FG00074 subjectsOne participant withdrew following the LT Period, prior to starting the Non-treatment Follow-up Period.
FG00177 subjectsTwo participants withdrew following the LT Period, prior to starting the Non-treatment Follow-up Period.
FG00259 subjectsTwo participants withdrew following the LT Period, prior to starting the Non-treatment Follow-up Period.
COMPLETED
FG00067 subjects
FG00168 subjects
FG00252 subjects
NOT COMPLETED
FG0007 subjects
FG0019 subjects
FG0027 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0020 subjects
Withdrawal by parent/guardian
FG000
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dapagliflozin
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 glycated haemoglobin (HbA1c) values < 7% remained on low-dose dapagliflozin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of dapagliflozin.
BG001
Saxagliptin
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of saxagliptin.
BG002
Placebo
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
At either Week 32 or Week 40 eligible participants receiving placebo (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00081
BG00188
BG00276
BG003245
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00014.4± 2.00
BG00114.5± 1.75
BG00214.7± 1.64
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00049
BG00153
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00045
BG00143
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00042
BG00150
BG002
Mean Baseline HbA1c
Mean
Standard Deviation
Percentage HbA1c
Title
Denominators
Categories
Title
Measurements
BG0008.22± 1.459
BG0018.02± 1.431
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on multiple imputation washout (MI-WO) within each arm using the data from placebo participants with Week 26 data.
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period.
Posted
Mean
Standard Error
Percentage HbA1c
Baseline and Week 26
ID
Title
Description
OG000
Dapagliflozin
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 glycated haemoglobin (HbA1c) values < 7% remained on low-dose dapagliflozin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of dapagliflozin.
OG001
Placebo
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
At either Week 32 or Week 40 eligible participants receiving placebo (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.
Units
Counts
Participants
OG00075
OG00170
Title
Denominators
Categories
Title
Measurements
OG000-0.62± 0.218
OG0010.41± 0.218
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
< 0.001
Adjusted mean difference
-1.03
Standard Error of the Mean
0.274
2-Sided
95
-1.57
-0.49
Superiority
Primary
Saxagliptin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period.
Posted
Mean
Standard Error
Percentage HbA1c
Baseline and Week 26
ID
Title
Description
OG000
Saxagliptin
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of saxagliptin.
Secondary
Dapagliflozin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Dapagliflozin 5 mg/10 mg and weighted as pre-specified in the statistical analysis plan.
Posted
Mean
Standard Error
Percentage HbA1c
Baseline and Week 26
ID
Title
Description
OG000
Dapagliflozin 5 mg/10 mg (Weighted)
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose dapagliflozin (weight = 1). Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment (weight = 0) or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose) (weight = 2).
After completion of the ST treatment period, participants could enter the LT treatment period.
Secondary
Saxagliptin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Saxagliptin 2.5 mg/5 mg and weighted as pre-specified in the statistical analysis plan.
Posted
Mean
Standard Error
Percentage HbA1c
Baseline and Week 26
ID
Title
Description
OG000
Saxagliptin 2.5 mg/5 mg (Weighted)
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose saxagliptin (weight = 1). Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment (weight = 0) or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose) (weight = 2).
After completion of the ST treatment period, participants could enter the LT treatment period.
Secondary
Dapagliflozin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Dapagliflozin 5 mg/10 mg and weighted as pre-specified in the statistical analysis plan.
Posted
Mean
Standard Error
Percentage HbA1c
Baseline and Week 26
ID
Title
Description
OG000
Dapagliflozin 5 mg/10 mg (Weighted)
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose dapagliflozin (weight = 1). Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment (weight = 0) or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose) (weight = 2).
After completion of the ST treatment period, participants could enter the LT treatment period.
Secondary
Saxagliptin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Saxagliptin 2.5 mg/5 mg and weighted as pre-specified in the statistical analysis plan.
Posted
Mean
Standard Error
Percentage HbA1c
Baseline and Week 26
ID
Title
Description
OG000
Saxagliptin 2.5 mg/5 mg (Weighted)
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose saxagliptin (weight = 1). Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment (weight = 0) or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose) (weight = 2).
After completion of the ST treatment period, participants could enter the LT treatment period.
Secondary
Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only.
Posted
Mean
Standard Error
mmol/L
Baseline and Week 26
ID
Title
Description
OG000
Dapagliflozin
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 glycated haemoglobin (HbA1c) values < 7% remained on low-dose dapagliflozin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of dapagliflozin.
Secondary
Saxagliptin Versus Placebo: Adjusted Mean Change From Baseline in FPG at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only.
Posted
Mean
Standard Error
mmol/L
Baseline and Week 26
ID
Title
Description
OG000
Saxagliptin
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of saxagliptin.
Secondary
Dapagliflozin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Dapagliflozin 5 mg/10 mg and weighted as pre-specified in the statistical analysis plan.
Posted
Mean
Standard Error
mmol/L
Baseline and Week 26
ID
Title
Description
OG000
Dapagliflozin 5 mg/10 mg (Weighted)
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose dapagliflozin (weight = 1). Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment (weight = 0) or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose) (weight = 2).
After completion of the ST treatment period, participants could enter the LT treatment period.
Secondary
Saxagliptin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Saxagliptin 2.5 mg/5 mg and weighted as pre-specified in the statistical analysis plan.
Posted
Mean
Standard Error
mmol/L
Baseline and Week 26
ID
Title
Description
OG000
Saxagliptin 2.5 mg/5 mg (Weighted)
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose saxagliptin (weight = 1). Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment (weight = 0) or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose) (weight = 2).
After completion of the ST treatment period, participants could enter the LT treatment period.
Secondary
Dapagliflozin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Dapagliflozin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Dapagliflozin 5 mg/10 mg and weighted as pre-specified in the statistical analysis plan.
Posted
Mean
Standard Error
mmol/L
Baseline and Week 26
ID
Title
Description
OG000
Dapagliflozin 5 mg/10 mg (Weighted)
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose dapagliflozin (weight = 1). Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment (weight = 0) or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose) (weight = 2).
After completion of the ST treatment period, participants could enter the LT treatment period.
Secondary
Saxagliptin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Saxagliptin participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with available data only. Data is pooled for Saxagliptin 2.5 mg/5 mg and weighted as pre-specified in the statistical analysis plan.
Posted
Mean
Standard Error
mmol/L
Baseline and Week 26
ID
Title
Description
OG000
Saxagliptin 2.5 mg/5 mg (Weighted)
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose saxagliptin (weight = 1). Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment (weight = 0) or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose) (weight = 2).
After completion of the ST treatment period, participants could enter the LT treatment period.
Secondary
Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26
A logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with Baseline HbA1c >= 7% and available data only.
Posted
Number
Percentage of participants
Baseline and Week 26
ID
Title
Description
OG000
Dapagliflozin
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 glycated haemoglobin (HbA1c) values < 7% remained on low-dose dapagliflozin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of dapagliflozin.
Secondary
Low-dose/High-dose Versus Placebo (Weighted): Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26
A weighted logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with Baseline HbA1c >= 7% and available data only. Data is pooled for Dapagliflozin 5 mg/10 mg and Saxagliptin 2.5 mg/5 mg and weighted as pre-specified in the statistical analysis plan.
Posted
Number
Percentage of participants
Baseline and Week 26
ID
Title
Description
OG000
Dapagliflozin 5 mg/10 mg (Weighted)
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose dapagliflozin (weight = 1). Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment (weight = 0) or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose) (weight = 2).
After completion of the ST treatment period, participants could enter the LT treatment period.
Secondary
Low-dose Versus Placebo (Weighted): Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26
A weighted logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Participants were weighted as follows: participants who had HbA1c < 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c >= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c >= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1.
Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period. Includes participants with Baseline HbA1c >= 7% and available data only. Data is pooled for Dapagliflozin 5 mg/10 mg and Saxagliptin 2.5 mg/5 mg and weighted as pre-specified in the statistical analysis plan.
Posted
Number
Percentage of participants
Baseline and Week 26
ID
Title
Description
OG000
Dapagliflozin 5 mg/10 mg (Weighted)
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose dapagliflozin (weight = 1). Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment (weight = 0) or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose) (weight = 2).
After completion of the ST treatment period, participants could enter the LT treatment period.
Secondary
Low-dose Versus Uptitration to the High Dose: Adjusted Mean Change From Baseline in HbA1c at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Uptitration Randomised Participants Data Set: consisted of the subset of randomised participants who were up-titration randomised because their HbA1c is greater than or equal to 7% at Week 12 (regardless of rescue medication initiation). Includes participants with available data only.
Posted
Mean
Standard Error
Percentage HbA1c
Baseline and Week 26
ID
Title
Description
OG000
Dapagliflozin 10 mg
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period.
OG001
Dapagliflozin 5 mg
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose dapagliflozin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period.
Secondary
Low-dose Versus Uptitration to the High Dose: Adjusted Mean Change From Baseline in FPG at Week 26
Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Uptitration Randomised Participants Data Set: consisted of the subset of randomised participants who were up-titration randomised because their HbA1c is greater than or equal to 7% at Week 12 (regardless of rescue medication initiation). Includes participants with available data only.
Posted
Mean
Standard Error
mmol/L
Baseline and Week 26
ID
Title
Description
OG000
Dapagliflozin 10 mg
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period.
OG001
Dapagliflozin 5 mg
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose dapagliflozin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period.
Secondary
Dapagliflozin Low-dose Versus Uptitration to the High Dose: Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26
A Fisher's exact test was used and unadjusted difference in percentage of participants and Clopper-Pearson CIs presented using imputed data. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Uptitration Randomised Participants Data Set: consisted of the subset of randomised participants who were up-titration randomised because their HbA1c is greater than or equal to 7% at Week 12 (regardless of rescue medication initiation). Includes participants with available data only.
Posted
Number
Percentage of participants
Baseline and Week 26
ID
Title
Description
OG000
Dapagliflozin 10 mg
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period.
OG001
Dapagliflozin 5 mg
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose dapagliflozin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period.
Secondary
Saxagliptin Low-dose Versus Uptitration to the High Dose: Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26
A Fisher's exact test was used and unadjusted difference in percentage of participants and Clopper-Pearson CIs presented using imputed data. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data.
Uptitration Randomised Participants Data Set: consisted of the subset of randomised participants who were up-titration randomised because their HbA1c is greater than or equal to 7% at Week 12 (regardless of rescue medication initiation). Includes participants with available data only.
Posted
Number
Percentage of participants
Baseline and Week 26
ID
Title
Description
OG000
Saxagliptin 5 mg
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period.
OG001
Saxagliptin 2.5 mg
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period.
Time Frame
All-cause mortality: Up to Week 104 Serious and other AEs: Up to 52 Weeks + 30 days (Week 56)
Description
Treated Participants Data Set: consisted of all participants who received at least one dose of study medication. As pre-specified in the statistical analysis plan, adverse events data for participants continuing on metformin following third randomization and for participants who were not eligible for the third randomization were not collected separately.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Weeks 1 to 14: Dapagliflozin 5 mg
Participants were randomised to receive dapagliflozin 5 mg administered orally once daily (low-dose).
0
81
1
81
35
81
EG001
Weeks 14 to 26: Dapagliflozin 5 mg
At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose dapagliflozin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).
0
55
0
55
14
55
EG002
Weeks 14 to 26: Dapagliflozin 10 mg
At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to dapagliflozin 10 mg administered orally once daily (high-dose).
0
21
0
21
4
21
EG003
Weeks 26 to 56: Dapagliflozin 5 mg
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. Participants who were randomized to continue background medication with metformin continued with their current dose of dapagliflozin.
0
55
5
55
26
55
EG004
Weeks 26 to 56: Dapagliflozin 10 mg
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. Participants who were randomized to continue background medication with metformin continued with their current dose of dapagliflozin.
0
21
1
21
8
21
EG005
Weeks 32 or 40 to 56: Dapagliflozin 10 mg + Metformin Withdrawal
After completion of the ST treatment period, participants could enter the LT treatment period.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment.
0
7
0
7
2
7
EG006
Weeks 1 to 14: Saxagliptin 2.5 mg
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose).
0
88
2
88
37
88
EG007
Weeks 14 to 26: Saxagliptin 2.5 mg
At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).
0
61
1
61
18
61
EG008
Weeks 14 to 26: Saxagliptin 5 mg
At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).
0
26
0
26
10
26
EG009
Weeks 26 to 56: Saxagliptin 2.5 mg
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. Participants who were randomized to continue background medication with metformin continued with their current dose of saxagliptin.
0
61
3
61
23
61
EG010
Weeks 26 to 56: Saxagliptin 5 mg
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. Participants who were randomized to continue background medication with metformin continued with their current dose of saxagliptin.
0
26
1
26
12
26
EG011
Weeks 32 or 40 to 56: Saxagliptin 5 mg + Metformin Withdrawal
After completion of the ST treatment period, participants could enter the LT treatment period.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment.
0
13
0
13
3
13
EG012
Weeks 1 to 14: Placebo
Participants were randomised to receive placebo administered orally once daily.
0
76
1
76
39
76
EG013
Weeks 14 to 26: Placebo
At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
0
70
1
70
24
70
EG014
Weeks 26 to 32 or 40: Placebo
After completion of the ST treatment period, participants could enter the LT treatment period.
Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
At either Week 32 or Week 40 eligible participants receiving placebo were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.
0
70
3
70
29
70
EG015
Weeks 32 or 40 to 56: Placebo
Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
At either Week 32 or Week 40 eligible participants receiving placebo were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.
0
53
0
53
2
53
EG016
Weeks 32 or 40 to 56: Placebo to Dapagliflozin 10 mg + Metformin Withdrawal
At either Week 32 or Week 40 eligible participants receiving placebo were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.
0
3
0
3
1
3
EG017
Weeks 32 or 40 to 56: Placebo to Saxagliptin 5 mg + Metformin Withdrawal
At either Week 32 or Week 40 eligible participants receiving placebo were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.
0
3
0
3
1
3
EG018
Week 56 to 104: Non-treatment Follow-up Period
Safety monitoring continued in the Non-treatment Follow-up Period quarterly between the Week 56 and Week 104 visits.
0
210
0
210
0
210
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Splenic rupture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG0031 events1 affected55 at risk
EG004
Glycosylated haemoglobin increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Transaminases increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Euglycaemic diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Covid-19
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hypoparathyroidism
Endocrine disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG0030 events0 affected55 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected88 at risk
EG0070 events0 affected61 at risk
EG0080 events0 affected26 at risk
EG0090 events0 affected61 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected13 at risk
EG0121 events1 affected76 at risk
EG0130 events0 affected70 at risk
EG0140 events0 affected70 at risk
EG0150 events0 affected53 at risk
EG0160 events0 affected3 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected210 at risk
Limb injury
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Scratch
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Albumin urine present
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Bacterial test
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Blood glucose increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Blood glucose normal
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Blood parathyroid hormone increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Blood pressure increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Primary hypothyroidism
Endocrine disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
C-telopeptide increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Crystal urine present
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Liver function test increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Mean cell haemoglobin concentration decreased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Mean cell haemoglobin decreased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Sars-cov-2 test positive
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Transaminases increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Cataract
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Urine albumin/creatinine ratio increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Vitamin d decreased
Investigations
MedDRA 25.1
Systematic Assessment
EG0002 events2 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Weight increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
White blood cells urine positive
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected21 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0004 events4 affected81 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Metabolic disorder
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Vitamin d deficiency
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0002 events2 affected81 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0007 events6 affected81 at risk
EG0015 events5 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0002 events2 affected81 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected21 at risk
EG003
Syncope
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Tremor
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Depression
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Generalised anxiety disorder
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Persistent depressive disorder
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Tic
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Diabetic nephropathy
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Microalbuminuria
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Nephropathy
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected21 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Amenorrhoea
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Premenstrual pain
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Nasal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Ingrown hair
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0003 events3 affected81 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected21 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Adenoidectomy
Surgical and medical procedures
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Nasal septal operation
Surgical and medical procedures
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Sphenoid sinus operation
Surgical and medical procedures
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Tonsillectomy
Surgical and medical procedures
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hot flush
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0004 events3 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Tooth impacted
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0003 events3 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Chest discomfort
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Chest pain
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Drug intolerance
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Fatigue
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Pain
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Pyrexia
General disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Swelling face
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Immunisation reaction
Immune system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Balanitis candida
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0011 events1 affected55 at risk
EG0021 events1 affected21 at risk
EG003
Covid-19
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Croup infectious
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Cystitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Ear infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Fungal balanitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Fungal foot infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Gastritis viral
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Left ventricular hypertrophy
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Influenza
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected21 at risk
EG003
Nail infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0012 events2 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Norovirus infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Otitis media
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Otitis media bacterial
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Paronychia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Pericoronitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0003 events3 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Wolff-parkinson-white syndrome
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0011 events1 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Tinea cruris
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Tonsillitis bacterial
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0003 events3 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Viral infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0021 events1 affected21 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Closed globe injury
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected81 at risk
EG0010 events0 affected55 at risk
EG0020 events0 affected21 at risk
EG003
Due to legal dispute, the source documents could not be accessed for 11 participants at 1 site. All data from this site were excluded as documented in the statistical analysis plan.
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
At either Week 32 or Week 40 eligible participants receiving placebo (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.
Units
Counts
Participants
OG00082
OG00170
Title
Denominators
Categories
Title
Measurements
OG0000.06± 0.198
OG0010.50± 0.202
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.078
Adjusted mean difference
-0.44
Standard Error of the Mean
0.251
2-Sided
95
-0.93
0.05
Superiority
OG001
Placebo (Weight = 1)
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period.
Units
Counts
Participants
OG00054
OG00170
Title
Denominators
Categories
Title
Measurements
OG000-0.42± 0.214
OG0010.43± 0.207
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.004
Adjusted mean difference
-0.86
Standard Error of the Mean
0.300
2-Sided
95
-1.44
-0.27
Superiority
OG001
Placebo (Weight = 1)
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period.
Units
Counts
Participants
OG00058
OG00170
Title
Denominators
Categories
Title
Measurements
OG000-0.04± 0.190
OG0010.47± 0.200
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.067
Adjusted mean difference
-0.51
Standard Error of the Mean
0.277
2-Sided
95
-1.05
0.04
Superiority
OG001
Placebo (Weight = 1)
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period.
Units
Counts
Participants
OG00056
OG00170
Title
Denominators
Categories
Title
Measurements
OG000-0.79± 0.202
OG0010.40± 0.205
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
< 0.001
Adjusted mean difference
-1.19
Standard Error of the Mean
0.290
2-Sided
95
-1.76
-0.62
Superiority
OG001
Placebo (Weight = 1)
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period.
Units
Counts
Participants
OG00057
OG00170
Title
Denominators
Categories
Title
Measurements
OG0000.07± 0.188
OG0010.47± 0.194
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.146
Adjusted mean difference
-0.39
Standard Error of the Mean
0.270
2-Sided
95
-0.92
0.14
Superiority
OG001
Placebo
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
At either Week 32 or Week 40 eligible participants receiving placebo (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.
Units
Counts
Participants
OG00075
OG00168
Title
Denominators
Categories
Title
Measurements
OG000-0.57± 0.374
OG0010.51± 0.384
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.024
Adjusted mean difference
-1.08
Standard Error of the Mean
0.479
2-Sided
95
-2.02
-0.14
Superiority
OG001
Placebo
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
At either Week 32 or Week 40 eligible participants receiving placebo (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.
Units
Counts
Participants
OG00080
OG00168
Title
Denominators
Categories
Title
Measurements
OG0000.08± 0.413
OG0010.19± 0.428
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.833
Adjusted mean difference
-0.11
Standard Error of the Mean
0.528
2-Sided
95
-1.15
0.92
Superiority
OG001
Placebo (Weight = 1)
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period.
Units
Counts
Participants
OG00054
OG00168
Title
Denominators
Categories
Title
Measurements
OG000-0.34± 0.365
OG0010.70± 0.369
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.047
Adjusted mean difference
-1.04
Standard Error of the Mean
0.525
2-Sided
95
-2.07
-0.01
Superiority
OG001
Placebo (Weight = 1)
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period.
Units
Counts
Participants
OG00057
OG00168
Title
Denominators
Categories
Title
Measurements
OG0000.18± 0.331
OG0010.73± 0.359
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.268
Adjusted mean difference
-0.54
Standard Error of the Mean
0.490
2-Sided
95
-1.50
0.42
Superiority
OG001
Placebo (Weight = 1)
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period.
Units
Counts
Participants
OG00056
OG00168
Title
Denominators
Categories
Title
Measurements
OG000-0.56± 0.347
OG0010.56± 0.363
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.026
Adjusted mean difference
-1.12
Standard Error of the Mean
0.505
2-Sided
95
-2.11
-0.13
Superiority
OG001
Placebo (Weight = 1)
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period.
Units
Counts
Participants
OG00055
OG00168
Title
Denominators
Categories
Title
Measurements
OG0000.63± 0.424
OG0010.34± 0.446
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.644
Adjusted mean difference
0.29
Standard Error of the Mean
0.618
2-Sided
95
-0.92
1.50
Superiority
OG001
Saxagliptin
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
A subset of eligible participants (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were grouped into 2 separate strata for saxagliptin and dapagliflozin, and then randomised 1:1 within each of the strata to either continue or discontinue background medication with metformin at either Week 32 or Week 40. For participants randomised to withdraw background treatment with metformin, those receiving high-dose treatment continued to receive high-dose treatment, whereas those currently receiving low-dose treatment had their doses uptitrated to high-dose treatment. Participants who were randomized to continue background medication with metformin continued with their current dose of saxagliptin.
OG002
Placebo
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period. Participants who were receiving background medication with insulin only or insulin and metformin (not eligible for the third randomisation) continued with their randomised study drug assigned after the second randomisation.
At either Week 32 or Week 40 eligible participants receiving placebo (on background treatment with metformin only and who had HbA1c < 7.5% at Week 26 or Week 32) were randomised 1:1:1 to either withdraw background medication with metformin and switch to active treatment with either saxagliptin 5 mg or dapagliflozin 10 mg or to remain on background medication with metformin and continue with placebo.
Units
Counts
Participants
OG00064
OG00161
OG00250
Title
Denominators
Categories
Title
Measurements
OG00026.6
OG00121.3
OG00210.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Regression, Logistic
0.019
Adjusted Odds Ratio
3.8
2-Sided
95
1.2
11.7
Superiority
OG001
OG002
Regression, Logistic
0.114
Adjusted Odds Ratio
2.6
2-Sided
95
0.8
8.6
Superiority
OG001
Saxagliptin 2.5 mg/5 mg (Weighted)
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose saxagliptin (weight = 1). Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment (weight = 0) or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose) (weight = 2).
After completion of the ST treatment period, participants could enter the LT treatment period.
OG002
Placebo (Weight = 1)
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period.
Units
Counts
Participants
OG00044
OG00141
OG00250
Title
Denominators
Categories
Title
Measurements
OG00027.3
OG00124.4
OG00210.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Weighted Logistic Regression
0.042
Adjusted Odds Ratio
3.5
2-Sided
95
1.0
11.4
Superiority
OG001
OG002
Weighted Logistic Regression
0.175
Adjusted Odds Ratio
2.3
2-Sided
95
0.7
7.4
Superiority
OG001
Saxagliptin 2.5 mg/5 mg (Weighted)
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose saxagliptin (weight = 1). Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment (weight = 0) or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose) (weight = 2).
After completion of the ST treatment period, participants could enter the LT treatment period.
OG002
Placebo (Weight = 1)
Participants were randomised to receive placebo administered orally once daily. At Week 14, all participants continued on placebo. To maintain blinding, all participants underwent a dummy second randomisation process that was undistinguishable from the actual second randomisation.
After completion of the ST treatment period, participants could enter the LT treatment period.
Units
Counts
Participants
OG00045
OG00138
OG00250
Title
Denominators
Categories
Title
Measurements
OG00035.6
OG00128.9
OG00210.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Weighted Logistic Regression
0.009
Adjusted Odds Ratio
4.4
2-Sided
95
1.4
13.2
Superiority
OG001
OG002
Weighted Logistic Regression
0.042
Adjusted Odds Ratio
3.8
2-Sided
95
1.1
13.5
Superiority
OG002
Saxagliptin 5 mg
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period.
OG003
Saxagliptin 2.5 mg
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period.
Units
Counts
Participants
OG00019
OG00121
OG00225
OG00324
Title
Denominators
Categories
Title
Measurements
OG000-0.74± 0.368
OG001-0.71± 0.384
OG002-0.16± 0.361
OG0030.07± 0.372
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.955
Adjusted mean difference
-0.03
Standard Error of the Mean
0.496
2-Sided
95
-1.00
0.94
Superiority
OG002
OG003
ANCOVA
0.640
Adjusted mean difference
-0.23
Standard Error of the Mean
0.495
2-Sided
95
-1.20
0.74
Superiority
OG002
Saxagliptin 5 mg
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period.
OG003
Saxagliptin 2.5 mg
Participants were randomised to receive saxagliptin 2.5 mg administered orally once daily (low-dose). At Week 14, participants with Week 12 HbA1c values < 7% remained on low-dose saxagliptin. Participants with Week 12 HbA1c values ≥ 7% were re-randomised in a 1:1 ratio to continue on low-dose treatment or to uptitrate to saxagliptin 5 mg administered orally once daily (high-dose).
After completion of the ST treatment period, participants could enter the LT treatment period.