MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)
Official Title
A Multicenter, Randomized, Double-Blind Factorial Study of the Co-Administration of MK0431 and Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Mar 2017
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
Mar 17, 2005Actual
Primary Completion Date
Jul 25, 2006Actual
Completion Date
Feb 21, 2008Actual
First Submitted Date
Feb 15, 2005
First Submission Date that Met QC Criteria
Feb 15, 2005
First Posted Date
Feb 16, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 19, 2009
Results First Submitted that Met QC Criteria
Mar 27, 2009
Results First Posted Date
May 19, 2009Estimated
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
Mar 31, 2017
Last Update Posted Date
May 5, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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 purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).
Detailed Description
Not provided
Conditions Module
Conditions
Type 2 Diabetes Mellitus
Keywords
Not provided
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
1,208Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
MK0431 100 mg q.d.
Drug: Comparator: MK0431 100 mg q.d. (q.d. = once daily)
2
Active Comparator
Metformin 500 mg b.i.d.
Drug: Comparator: Metformin 500 mg b.i.d.
3
Active Comparator
Metformin 1000 mg b.i.d.
Drug: Comparator: Metformin 1000 mg b.i.d.
4
Experimental
Coadministration of MK0431 and Metformin 50/500 mg b.i.d.
MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take MK0431 50 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
Week 24
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Week 24
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
54-Week Base Study:
Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes)
50-Week Extension Study:
Patients who complete the 54-week base study are eligible to enter the 50-week extension study
Exclusion Criteria:
Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)
Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams-Herman DE; Sitagliptin 036 Study Group. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007 Aug;30(8):1979-87. doi: 10.2337/dc07-0627. Epub 2007 May 7.
Patients 18-78 years with T2DM and an HbA1c 7.5-11% on diet/exercise were eligible for randomization into the 54-week (wk) base study. Patients with an HbA1c >11% or glucose >280 mg/dL were eligible to participate in the Open-label Cohort through Wk 24. Randomized patients who completed the base study were eligible to enter a 50-wk extension study.
Recruitment Details
First Patient In: 01-Apr-2005
Last Patient Last Visit: 29-Feb-2008
140 study centers worldwide
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Sitagliptin 100 mg q.d.
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
Periods
Title
Milestones
Reasons Not Completed
54-Week Base Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Australia
Colombia
Costa Rica
Guatemala
Hungary
Lithuania
Malaysia
New Zealand
Norway
Peru
Philippines
Puerto Rico
Russia
South Africa
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Factorial Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Comparator: Placebo (Phase A)/Metformin (Phase B)
7
Experimental
Non-Randomized, Open-Label: Coadministration MK0431 and Metformin 50/1000 mg b.i.d.
Comparator: MK0431 100 mg q.d. (q.d. = once daily)
Drug
MK0431 oral tablets will be started on Day 1 as two 50 mg tablets (100 mg q.d.) (q.d. = once daily) and continued at this dose throughout the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
1
Comparator: Placebo (Phase A)/Metformin (Phase B)
Drug
During the placebo-controlled period (Day 1 through Week 24/Phase A), metformin and MK0431 matching placebos will be dispensed as oral tablets. At the beginning of the 30-week active-controlled period (Phase B), metformin will be started as 500 mg q.d. (q.d. = once daily) and up-titrated in 500 mg weekly increments to a stable dose of 1000 mg b.i.d. Patients who complete the 54-week base study and who enter the 50-week extension study will continue to take metformin 1000 mg b.i.d. (b.i.d. = twice daily) for a total placebo/metformin treatment duration of up to 104 weeks.
6
Comparator: Metformin 500 mg b.i.d.
Drug
Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased after 1 week to a stable dose of 500 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 500 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Metformin oral tablets will be started on Day 1 at 500 mg q.d. and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. The open-label treatment period is 24 weeks.
7
Comparator: Metformin 1000 mg b.i.d.
Drug
Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 1000 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
3
5
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Week 24
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54
HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.
Week 54
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54
Change from baseline at Week 54 is defined as Week 54 minus Week 0.
Week 54
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54
Change from baseline at Week 54 is defined as Week 54 minus Week 0.
Week 54
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104
HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
Week 104
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104
Change from baseline at Week 104 is defined as Week 104 minus Week 0.
Week 104
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104
Change from baseline at Week 104 is defined as Week 104 minus Week 0.
Week 104
Derived
Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
FG001
Metformin 500 mg b.i.d.
The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
FG002
Metformin 1000 mg b.i.d.
The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
FG005
Placebo/Metformin 1000 mg b.i.d.
The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
FG000179 subjects
FG001182 subjects
FG002182 subjects
FG003190 subjects
FG004182 subjects
FG005176 subjects
FG006117 subjectsResults for the OLC are through Week 24. Results for the 6 randomized groups are through Week 54.
COMPLETED
FG000122 subjects
FG001126 subjects
FG002135 subjects
FG003148 subjects
FG004141 subjects
FG005115 subjects
FG00679 subjects
NOT COMPLETED
FG00057 subjects
FG00156 subjects
FG00247 subjects
FG00342 subjects
FG00441 subjects
FG00561 subjects
FG00638 subjects
Type
Comment
Reasons
Adverse Event
FG00012 subjects
FG0019 subjects
FG00211 subjects
FG0036 subjects
FG0045 subjects
FG00511 subjects
FG0063 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG00011 subjects
FG00114 subjects
FG0028 subjects
FG0034 subjects
FG004
Lost to Follow-up
FG0005 subjects
FG0014 subjects
FG0027 subjects
FG0035 subjects
FG004
Physician Decision
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Pregnancy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0006 subjects
FG0014 subjects
FG0022 subjects
FG0034 subjects
FG004
Withdrawal by Subject
FG00017 subjects
FG00116 subjects
FG00216 subjects
FG00315 subjects
FG004
protocol discontinuation criteria
FG0002 subjects
FG0015 subjects
FG0022 subjects
FG0036 subjects
FG004
patient moved
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
non-compliance with study procedures
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
patient incarcerated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
laboratory reporting error
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
site error
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
patient intolerance to rescue therapy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
50-Week Extension Study
Type
Comment
Milestone Data
STARTED
FG000103 subjects19 randomized patients completed Period 1 but did not enter Period 2.
FG001107 subjects19 randomized patients completed Period 1 but did not enter Period 2.
FG002121 subjects14 randomized patients completed Period 1 but did not enter Period 2.
FG003134 subjects14 randomized patients completed Period 1 but did not enter Period 2.
FG004122 subjects19 randomized patients completed Period 1 but did not enter Period 2.
FG00598 subjects17 randomized patients completed Period 1 but did not enter Period 2.
FG0060 subjects
COMPLETED
FG00065 subjects
FG00180 subjects
FG00295 subjects
FG00398 subjects
FG004
NOT COMPLETED
FG00038 subjects
FG00127 subjects
FG00226 subjects
FG00336 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0013 subjects
FG0022 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Sitagliptin 100 mg q.d.
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
BG001
Metformin 500 mg b.i.d.
The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
BG002
Metformin 1000 mg b.i.d.
The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
BG005
Placebo/Metformin 1000 mg b.i.d.
The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000179
BG001182
BG002182
BG003190
BG004182
BG005176
BG006117
BG0071208
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
BG00053.3± 10.2
BG00153.4± 10.2
BG00253.2± 9.6
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00086
BG00193
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG00093
BG00187
BG002
HbA1c (Hemoglobin A1c)
Mean
Standard Deviation
Percent
Title
Denominators
Categories
Title
Measurements
BG0008.9± 1.0
BG0018.9± 1.0
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
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.
Posted
Least Squares Mean
95% Confidence Interval
Percent
Week 24
ID
Title
Description
OG000
Sitagliptin 100 mg q.d.
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
OG001
Metformin 500 mg b.i.d.
The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG002
Metformin 1000 mg b.i.d.
The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG005
Placebo/Metformin 1000 mg b.i.d.
The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
Units
Counts
Participants
OG000175
OG001178
OG002177
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.66(-0.83 to -0.50)
OG001-0.82(-0.98 to -0.66)
OG002-1.13(-1.29 to -0.97)
OG003
Secondary
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Week 24
ID
Title
Description
OG000
Sitagliptin 100 mg q.d.
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
OG001
Secondary
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Week 24
ID
Title
Description
OG000
Sitagliptin 100 mg q.d.
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
OG001
Secondary
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54
HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.
The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.
Posted
Least Squares Mean
95% Confidence Interval
Percent
Week 54
ID
Title
Description
OG000
Sitagliptin 100 mg q.d.
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
OG001
Secondary
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54
Change from baseline at Week 54 is defined as Week 54 minus Week 0.
The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Week 54
ID
Title
Description
OG000
Sitagliptin 100 mg q.d.
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
OG001
Metformin 500 mg b.i.d.
Secondary
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54
Change from baseline at Week 54 is defined as Week 54 minus Week 0.
The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Week 54
ID
Title
Description
OG000
Sitagliptin 100 mg q.d.
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
OG001
Metformin 500 mg b.i.d.
Secondary
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104
HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.
Posted
Least Squares Mean
95% Confidence Interval
Percent
Week 104
ID
Title
Description
OG000
Sitagliptin 100 mg q.d.
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
OG001
Secondary
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104
Change from baseline at Week 104 is defined as Week 104 minus Week 0.
The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Week 104
ID
Title
Description
OG000
Sitagliptin 100 mg q.d.
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
OG001
Metformin 500 mg b.i.d.
Secondary
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104
Change from baseline at Week 104 is defined as Week 104 minus Week 0.
The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Week 104
ID
Title
Description
OG000
Sitagliptin 100 mg q.d.
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
OG001
Metformin 500 mg b.i.d.
Time Frame
Not provided
Description
Not provided
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
Sitagliptin 100 mg q.d.
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
15
71
EG001
Metformin 500 mg b.i.d.
The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
10
74
EG002
Metformin 1000 mg b.i.d.
The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
13
94
EG005
Placebo/Metformin 1000 mg b.i.d.
The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
3
40
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Any Blood And Lymphatic System Disorders
Blood and lymphatic system disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG0030 affected190 at risk
EG004
Lymphadenopathy Mediastinal
Blood and lymphatic system disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Any Cardiac Disorders
Cardiac disorders
MedDRA 10.1
Non-systematic Assessment
EG0002 affected179 at risk
EG0011 affected182 at risk
EG0023 affected182 at risk
EG003
Acute Coronary Syndrome
Cardiac disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Angina Unstable
Cardiac disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Myocardial Ischaemia
Cardiac disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0011 affected182 at risk
EG0020 affected182 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Any Congenital, Familial And Genetic Disorders
Congenital, familial and genetic disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Exomphalos
Congenital, familial and genetic disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Any Ear And Labyrinth Disorders
Ear and labyrinth disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Vertigo Positional
Ear and labyrinth disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Any Gastrointestinal Disorders
Gastrointestinal disorders
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Abdominal Hernia
Gastrointestinal disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Pancreatitis Acute
Gastrointestinal disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Swollen Tongue
Gastrointestinal disorders
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Umbilical Hernia, Obstructive
Gastrointestinal disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Any General Disorders And Administration Site Conditions
General disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0011 affected182 at risk
EG0020 affected182 at risk
EG003
Death
General disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Hernia Obstructive
General disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0011 affected182 at risk
EG0020 affected182 at risk
EG003
Sudden Cardiac Death
General disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Any Hepatobiliary Disorders
Hepatobiliary disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0011 affected182 at risk
EG0021 affected182 at risk
EG003
Cholangitis Acute
Hepatobiliary disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0011 affected182 at risk
EG0020 affected182 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Any Immune System Disorders
Immune system disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Anaphylactic Reaction
Immune system disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Any Infections And Infestations
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0003 affected179 at risk
EG0012 affected182 at risk
EG0021 affected182 at risk
EG003
Arthritis Infective
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0011 affected182 at risk
EG0020 affected182 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Diabetic Foot Infection
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Perineal Abscess
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Peritonsillar Abscess
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Scrotal Abscess
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Sepsis
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0011 affected182 at risk
EG0020 affected182 at risk
EG003
Any Injury, Poisoning And Procedural Complications
Injury, poisoning and procedural complications
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0011 affected182 at risk
EG0024 affected182 at risk
EG003
Acetabulum Fracture
Injury, poisoning and procedural complications
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Electric Shock
Injury, poisoning and procedural complications
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Femur Fracture
Injury, poisoning and procedural complications
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0011 affected182 at risk
EG0020 affected182 at risk
EG003
Meniscus Lesion
Injury, poisoning and procedural complications
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Multiple Injuries
Injury, poisoning and procedural complications
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Postoperative Thoracic Procedure Complication
Injury, poisoning and procedural complications
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Tendon Injury
Injury, poisoning and procedural complications
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0011 affected182 at risk
EG0020 affected182 at risk
EG003
Tendon Rupture
Injury, poisoning and procedural complications
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Upper Limb Fracture
Injury, poisoning and procedural complications
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Any Investigations
Investigations
MedDRA 10.1
Non-systematic Assessment
EG0000 affected178 at risk
EG0010 affected181 at risk
EG0020 affected181 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 10.1
Non-systematic Assessment
EG0000 affected163 at risk
EG0010 affected171 at risk
EG0020 affected170 at risk
EG003
Any Metabolism And Nutrition Disorders
Metabolism and nutrition disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Gestational Diabetes
Metabolism and nutrition disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Ketoacidosis
Metabolism and nutrition disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Any Musculoskeletal And Connective Tissue Disorders
Musculoskeletal and connective tissue disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0011 affected182 at risk
EG0021 affected182 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0011 affected182 at risk
EG0020 affected182 at risk
EG003
Any Neoplasms Benign, Malignant And Unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Non-systematic Assessment
EG0004 affected179 at risk
EG0013 affected182 at risk
EG0022 affected182 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Bladder Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0021 affected182 at risk
EG003
Glomus Tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0011 affected182 at risk
EG0020 affected182 at risk
EG003
Lung Neoplasm Malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0011 affected182 at risk
EG0020 affected182 at risk
EG003
Malignant Melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Oesophageal Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0011 affected182 at risk
EG0020 affected182 at risk
EG003
Pancreatic Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Pyogenic Granuloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Renal Cell Carcinoma Stage Unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Retroperitoneal Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Squamous Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Any Nervous System Disorders
Nervous system disorders
MedDRA 10.1
Non-systematic Assessment
EG0002 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Cervicobrachial Syndrome
Nervous system disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Syncope
Nervous system disorders
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Thalamic Infarction
Nervous system disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Any Renal And Urinary Disorders
Renal and urinary disorders
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Micturition Urgency
Renal and urinary disorders
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Any Reproductive System And Breast Disorders
Reproductive system and breast disorders
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Adenomyosis
Reproductive system and breast disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Endometrial Hyperplasia
Reproductive system and breast disorders
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Any Respiratory, Thoracic And Mediastinal Disorders
Respiratory, thoracic and mediastinal disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Any Vascular Disorders
Vascular disorders
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Peripheral Vascular Disorder
Vascular disorders
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Varicose Vein
Vascular disorders
MedDRA 10.1
Non-systematic Assessment
EG0001 affected179 at risk
EG0010 affected182 at risk
EG0020 affected182 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Any Gastrointestinal Disorders
Gastrointestinal disorders
MedDRA 10.1
Non-systematic Assessment
EG00019 affected179 at risk
EG00123 affected182 at risk
EG00242 affected182 at risk
EG00331 affected190 at risk
EG00435 affected182 at risk
EG00517 affected176 at risk
EG00618 affected117 at risk
Constipation
Gastrointestinal disorders
MedDRA 10.1
Non-systematic Assessment
EG0009 affected179 at risk
EG0016 affected182 at risk
EG0026 affected182 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 10.1
Non-systematic Assessment
EG0008 affected179 at risk
EG00114 affected182 at risk
EG00223 affected182 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 10.1
Non-systematic Assessment
EG0002 affected179 at risk
EG0016 affected182 at risk
EG00219 affected182 at risk
EG003
Any Infections And Infestations
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG00040 affected179 at risk
EG00144 affected182 at risk
EG00253 affected182 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0003 affected179 at risk
EG0013 affected182 at risk
EG00210 affected182 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0009 affected179 at risk
EG0011 affected182 at risk
EG0023 affected182 at risk
EG003
Influenza
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0008 affected179 at risk
EG00111 affected182 at risk
EG00214 affected182 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG00011 affected179 at risk
EG0019 affected182 at risk
EG00211 affected182 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG00012 affected179 at risk
EG00117 affected182 at risk
EG00220 affected182 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 10.1
Non-systematic Assessment
EG0000 affected179 at risk
EG0018 affected182 at risk
EG00213 affected182 at risk
EG003
Fasting blood glucose increased
Investigations
MedDRA 10.1
Non-systematic Assessment
EG0008 affected178 at risk
EG0013 affected180 at risk
EG0021 affected181 at risk
EG003
Any Musculoskeletal And Connective Tissue Disorders
Musculoskeletal and connective tissue disorders
MedDRA 10.1
Non-systematic Assessment
EG00016 affected179 at risk
EG00120 affected182 at risk
EG00221 affected182 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 10.1
Non-systematic Assessment
EG0007 affected179 at risk
EG0017 affected182 at risk
EG00211 affected182 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 10.1
Non-systematic Assessment
EG0009 affected179 at risk
EG0019 affected182 at risk
EG0027 affected182 at risk
EG003
Any Nervous System Disorders
Nervous system disorders
MedDRA 10.1
Non-systematic Assessment
EG0009 affected179 at risk
EG00113 affected182 at risk
EG00220 affected182 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 10.1
Non-systematic Assessment
EG0003 affected179 at risk
EG0015 affected182 at risk
EG00211 affected182 at risk
EG003
Headache
Nervous system disorders
MedDRA 10.1
Non-systematic Assessment
EG0006 affected179 at risk
EG0019 affected182 at risk
EG00212 affected182 at risk
EG003
Non-serious adverse experience results represent those events included in the primary safety analysis for this study (i.e., events that occurred prior to the initiation of glycemic rescue therapy).
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
1-800-672-6372
ID
Term
D003924
Diabetes Mellitus, Type 2
Ancestor Terms
ID
Term
D003920
Diabetes Mellitus
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068900
Sitagliptin Phosphate
D008687
Metformin
Ancestor Terms
ID
Term
D014230
Triazoles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D011719
Pyrazines
D001645
Biguanides
D006146
Guanidines
D000578
Amidines
D009930
Organic Chemicals
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0051 subjects
FG0060 subjects
3 subjects
FG00514 subjects
FG00619 subjects
10 subjects
FG0059 subjects
FG0063 subjects
1 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0061 subjects
0 subjects
FG0053 subjects
FG0063 subjects
10 subjects
FG00515 subjects
FG0064 subjects
5 subjects
FG0053 subjects
FG0065 subjects
3 subjects
FG0051 subjects
FG0060 subjects
0 subjects
FG0052 subjects
FG0060 subjects
1 subjects
FG0051 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0051 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
101 subjects
FG00578 subjects
FG0060 subjects
21 subjects
FG00520 subjects
FG0060 subjects
0 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Lack of Efficacy
FG00026 subjects
FG00115 subjects
FG00213 subjects
FG00316 subjects
FG0048 subjects
FG0058 subjects
FG0060 subjects
Lost to Follow-up
FG0004 subjects
FG0010 subjects
FG0021 subjects
FG0034 subjects
FG0043 subjects
FG0053 subjects
FG0060 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
Protocol Violation
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Withdrawal by Subject
FG0002 subjects
FG0015 subjects
FG0022 subjects
FG0038 subjects
FG0043 subjects
FG0053 subjects
FG0060 subjects
protocol discontinuation criteria
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0032 subjects
FG0043 subjects
FG0053 subjects
FG0060 subjects
non-compliance with study procedures
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
patient moved
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
patient scheduled for elective surgery
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
reason unspecified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
54.1
± 10.0
BG00453.3± 9.6
BG00553.6± 10.0
BG00652.6± 10.0
BG00753.4± 9.9
100
BG00385
BG004105
BG00583
BG00650
BG007602
Male
BG00093
BG00189
BG00282
BG003105
BG00477
BG00593
BG00667
BG007606
106
BG003102
BG00495
BG00581
BG00644
BG007608
Black
Title
Measurements
BG00011
BG00112
BG0029
BG00313
BG00414
BG00517
BG0069
BG00785
Hispanic
Title
Measurements
BG00052
BG00155
BG00239
BG00355
BG00449
BG00547
BG00654
BG007351
Asian
Title
Measurements
BG0006
BG00114
BG00210
BG0039
BG00411
BG00512
BG0061
BG00763
Other
Title
Measurements
BG00017
BG00114
BG00218
BG00311
BG00413
BG00519
BG0069
BG007101
8.7
± 0.9
BG0038.8± 1.0
BG0048.7± 0.9
BG0058.7± 1.0
BG00611.2± 1.2
BG0079.0± 1.2
183
OG004178
OG005165
-1.40
(-1.56 to -1.24)
OG004-1.90(-2.06 to -1.74)
OG0050.17(0.00 to 0.33)
Metformin 500 mg b.i.d.
The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG002
Metformin 1000 mg b.i.d.
The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG005
Placebo/Metformin 1000 mg b.i.d.
The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
Units
Counts
Participants
OG000178
OG001179
OG002179
OG003183
OG004180
OG005169
Title
Denominators
Categories
Title
Measurements
OG000-17.5(-24.1 to -10.8)
OG001-27.3(-34.0 to -20.7)
OG002-29.3(-35.9 to -22.6)
OG003-47.1(-53.7 to -40.6)
OG004-63.9(-70.5 to -57.3)
OG0055.8(-1.0 to 12.7)
Metformin 500 mg b.i.d.
The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG002
Metformin 1000 mg b.i.d.
The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG005
Placebo/Metformin 1000 mg b.i.d.
The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
Units
Counts
Participants
OG000136
OG001141
OG002138
OG003147
OG004152
OG005129
Title
Denominators
Categories
Title
Measurements
OG000-51.9(-62.3 to -41.5)
OG001-53.4(-63.6 to -43.2)
OG002-78.0(-88.3 to -67.6)
OG003-92.5(-102.6 to -82.5)
OG004-116.6(-126.4 to -106.7)
OG0050.3(-10.4 to 11.0)
Metformin 500 mg b.i.d.
The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG002
Metformin 1000 mg b.i.d.
The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG005
Placebo/Metformin 1000 mg b.i.d.
The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
Units
Counts
Participants
OG000106
OG001117
OG002134
OG003147
OG004153
OG00578
Title
Denominators
Categories
Title
Measurements
OG000-0.82(-1.00 to -0.63)
OG001-1.01(-1.18 to -0.83)
OG002-1.34(-1.50 to -1.17)
OG003-1.41(-1.57 to -1.25)
OG004-1.80(-1.96 to -1.65)
OG005-1.10(-1.32 to -0.88)
The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG002
Metformin 1000 mg b.i.d.
The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG005
Placebo/Metformin 1000 mg b.i.d.
The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
Units
Counts
Participants
OG000105
OG001117
OG002134
OG003146
OG004153
OG00578
Title
Denominators
Categories
Title
Measurements
OG000-16.0(-23.2 to -8.7)
OG001-29.0(-35.9 to -22.2)
OG002-39.6(-46.0 to -33.2)
OG003-42.5(-48.6 to -36.3)
OG004-55.6(-61.6 to -49.6)
OG005-43.9(-52.3 to -35.5)
The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG002
Metformin 1000 mg b.i.d.
The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG005
Placebo/Metformin 1000 mg b.i.d.
The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
Units
Counts
Participants
OG00087
OG00192
OG002116
OG003121
OG004132
OG00566
Title
Denominators
Categories
Title
Measurements
OG000-45.9(-57.2 to -34.6)
OG001-58.6(-69.6 to -47.6)
OG002-76.3(-86.1 to -66.5)
OG003-89.6(-99.2 to -80.0)
OG004-107.9(-117.1 to -98.7)
OG005-80.9(-93.9 to -67.9)
Metformin 500 mg b.i.d.
The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG002
Metformin 1000 mg b.i.d.
The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG005
Placebo/Metformin 1000 mg b.i.d.
The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
Units
Counts
Participants
OG00050
OG00164
OG00287
OG00396
OG004105
OG00542
Title
Denominators
Categories
Title
Measurements
OG000-1.15(-1.37 to -0.92)
OG001-1.06(-1.26 to -0.87)
OG002-1.34(-1.51 to -1.17)
OG003-1.39(-1.55 to -1.22)
OG004-1.66(-1.81 to -1.50)
OG005-1.39(-1.63 to -1.15)
The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG002
Metformin 1000 mg b.i.d.
The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG005
Placebo/Metformin 1000 mg b.i.d.
The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
Units
Counts
Participants
OG00050
OG00163
OG00287
OG00396
OG004105
OG00541
Title
Denominators
Categories
Title
Measurements
OG000-26.8(-36.2 to -17.4)
OG001-41.4(-49.8 to -33.0)
OG002-43.2(-50.3 to -36.2)
OG003-47.5(-54.3 to -40.7)
OG004-57.3(-63.7 to -50.8)
OG005-45.2(-55.7 to -34.8)
The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG002
Metformin 1000 mg b.i.d.
The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
OG005
Placebo/Metformin 1000 mg b.i.d.
The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.