Study of BMS-477118 as Monotherapy With Titration in Subj... | NCT00316082 | Trialant
NCT00316082
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Apr 29, 2015Estimated
Enrollment
365Actual
Phase
Phase 3
Conditions
Diabetes
Interventions
Saxagliptin
Saxagliptin
Saxagliptin
Saxagliptin
Placebo
metformin
Countries
United States
India
Russia
Taiwan
Protocol Section
Identification Module
NCT ID
NCT00316082
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CV181-038
Secondary IDs
Not provided
Brief Title
Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Mar 2015
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
Jun 2006
Primary Completion Date
Nov 2007Actual
Completion Date
Nov 2008Actual
First Submitted Date
Apr 18, 2006
First Submission Date that Met QC Criteria
Apr 19, 2006
First Posted Date
Apr 20, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 17, 2009
Results First Submitted that Met QC Criteria
Aug 17, 2009
Results First Posted Date
Sep 25, 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
Apr 8, 2015
Last Update Posted Date
Apr 29, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise
Detailed Description
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (rescue medication) added onto their blinded study medication
Conditions Module
Conditions
Diabetes
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
365Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Saxagliptin 2.5 mg QAM (A)
Experimental
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Drug: metformin
Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
Experimental
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Drug: metformin
Saxagliptin 5 mg QAM (C)
Experimental
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Drug: metformin
Saxagliptin 5 mg QPM (D)
Experimental
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Drug: metformin
Placebo (E)
Placebo Comparator
PLUS open-label metformin (as needed as rescue medication)
Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.
Bonora E, Bryzinski B, Hirshberg B, Cook W. A post hoc analysis of saxagliptin efficacy and safety in patients with type 2 diabetes stratified by UKPDS 10-year cardiovascular risk score. Nutr Metab Cardiovasc Dis. 2016 May;26(5):374-9. doi: 10.1016/j.numecd.2015.11.004. Epub 2015 Dec 1.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Saxagliptin 2.5 mg Once in the Morning (QAM)
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Placebo (E)
Saxagliptin 2.5 mg QAM (A)
Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
Saxagliptin 5 mg QAM (C)
Saxagliptin 5 mg QPM (D)
Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Baseline, Week 24
Percentage of Participants Achieving A1C < 7% at Week 24
Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin versus placebo at Week 24.
Week 24
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.
Baseline, Week 24
Haleyville
Alabama
35565
United States
Clinical Reseacrh Advantage/ Brown Family Medicine
Mesa
Arizona
85213
United States
Strategos Medical Group
Bakersfield
California
93311
United States
Providence Clinical Research
Burbank
California
91505
United States
Rx For Life, Inc
Cudahy
California
90201
United States
Medical Group Of Encino
Encino
California
91436
United States
Southland Clinical Research Center, Inc.
Fountain Valley
California
92708
United States
Valley Research
Fresno
California
93720
United States
Diabetes Medical Center Of California
Northridge
California
91325
United States
In Private Prictice Clinic
Pico Rivera
California
90660
United States
San Jose Clinical Research, Inc.
San Jose
California
95128
United States
Central Florida Clinical Trials, Inc.
Altamonte Springs
Florida
32714
United States
Accelovance
Melbourne
Florida
32935
United States
University Family Healthcare, Pa
Sarasota
Florida
34243
United States
Premier Healthcare
St. Petersburg
Florida
33707
United States
Pinnacle Medical Research
Overland Park
Kansas
66215
United States
Kansas City University Of Medicine And Biosciences
Frederich R, McNeill R, Berglind N, Fleming D, Chen R. The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-naive patients with type 2 diabetes mellitus: a randomized controlled trial. Diabetol Metab Syndr. 2012 Jul 24;4(1):36. doi: 10.1186/1758-5996-4-36.
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
FG002
Saxagliptin 2.5/5 mg QAM
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
FG003
Saxagliptin 5 mg Once in the Evening (QPM)
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
FG004
Placebo
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
FG00074 subjects
FG00174 subjects
FG00271 subjects
FG00372 subjects
FG00474 subjects
Completed Study Without Being Rescued
FG00025 subjects
FG00135 subjects
FG00229 subjects
FG00327 subjects
FG00431 subjects
COMPLETED
FG00041 subjects
FG00152 subjects
FG00244 subjects
FG00346 subjects
FG00448 subjects
NOT COMPLETED
FG00033 subjects
FG00122 subjects
FG00227 subjects
FG00326 subjects
FG00426 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0002 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
FG0046 subjects
Withdrawal of Consent by Subject
FG00010 subjects
FG0018 subjects
FG0022 subjects
FG0039 subjects
FG004
Lost to Follow-up
FG0007 subjects
FG0016 subjects
FG0027 subjects
FG0038 subjects
FG004
Poor/noncompliance
FG0006 subjects
FG0011 subjects
FG0024 subjects
FG0031 subjects
FG004
Adverse Event
FG0004 subjects
FG0012 subjects
FG0025 subjects
FG0031 subjects
FG004
Subject no longer meets study criteria
FG0003 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG004
Physician Decision
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Administrative reason by sponsor
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Saxagliptin 2.5 mg Once in the Morning (QAM)
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
BG001
Saxagliptin 5 mg QAM
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
BG002
Saxagliptin 2.5/5 mg QAM
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
BG003
Saxagliptin 5 mg Once in the Evening (QPM)
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
BG004
Placebo
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00074
BG00174
BG00271
BG00372
BG00474
BG005365
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
BG00055.24± 10.44
BG00154.66± 9.71
BG00254.28± 10.93
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00049
BG00136
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 Hemoglobin A1 (A1C) at Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.
Posted
Mean
Standard Error
percent
Baseline, Week 24
ID
Title
Description
OG000
Saxagliptin 2.5 mg QAM
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
OG001
Saxagliptin 5 mg QAM
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
OG002
Saxagliptin 2.5/5 mg QAM
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
OG003
Placebo
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
Units
Counts
Participants
OG00067
OG00169
OG00269
OG003
Title
Denominators
Categories
Baseline Mean
Title
Measurements
OG0008.04± 0.105
OG0017.93± 0.106
OG0028.02± 0.131
OG003
Secondary
Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
Posted
Mean
Standard Error
percent
Baseline, Week 24
ID
Title
Description
OG000
Saxagliptin 5 mg QPM
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
OG001
Placebo
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
Posted
Mean
Standard Error
mg/dL
Baseline, Week 24
ID
Title
Description
OG000
Saxagliptin 2.5 mg Once in the Morning (QAM)
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
OG001
Saxagliptin 5 mg QAM
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
OG002
Saxagliptin 2.5/5 mg QAM
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
Secondary
Percentage of Participants Achieving A1C < 7% at Week 24
Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin versus placebo at Week 24.
Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
Posted
Number
Percentage of participants
Week 24
ID
Title
Description
OG000
Saxagliptin 2.5 mg Once in the Morning (QAM)
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
OG001
Saxagliptin 5 mg QAM
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
OG002
Saxagliptin 2.5/5 mg QAM
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
Secondary
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
Posted
Mean
Standard Error
mg*min/dL
Baseline, Week 24
ID
Title
Description
OG000
Saxagliptin 2.5 mg Once in the Morning (QAM)
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
OG001
Saxagliptin 5 mg QAM
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
OG002
Saxagliptin 2.5/5 mg QAM
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
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
Placebo
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
5
74
22
74
EG001
Saxagliptin 2.5/5 mg QAM
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
7
71
30
71
EG002
Saxagliptin 2.5 mg QAM
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
7
74
32
74
EG003
Saxagliptin 5 mg QAM
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
8
74
33
74
EG004
Saxagliptin 5 mg QPM
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
4
72
29
72
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
RETINAL DETACHMENT
Eye disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG0031 affected74 at risk
EG0040 affected72 at risk
ANGINA PECTORIS
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
ANGINA UNSTABLE
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0021 affected74 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0011 affected71 at risk
EG0020 affected74 at risk
EG003
COR PULMONALE ACUTE
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0021 affected74 at risk
EG003
CORONARY ARTERY DISEASE
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0021 affected74 at risk
EG003
ACUTE MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA 11.1
Systematic Assessment
EG0002 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
ARTERIAL DISORDER
Vascular disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
CHOLECYSTITIS
Hepatobiliary disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0011 affected71 at risk
EG0020 affected74 at risk
EG003
CHOLECYSTITIS ACUTE
Hepatobiliary disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
TRANSIENT ISCHAEMIC ATTACK
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0001 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
RECTAL POLYP
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
FOOD POISONING
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0011 affected71 at risk
EG0020 affected74 at risk
EG003
GASTRITIS EROSIVE
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0021 affected74 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0021 affected74 at risk
EG003
INFECTED BITES
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0011 affected71 at risk
EG0020 affected74 at risk
EG003
PNEUMOCOCCAL SEPSIS
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0011 affected71 at risk
EG0020 affected74 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
CALCULUS URETERIC
Renal and urinary disorders
MedDRA 11.1
Systematic Assessment
EG0001 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
HYPOGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 11.1
Systematic Assessment
EG0001 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
INTERTRIGO
Skin and subcutaneous tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0021 affected74 at risk
EG003
OVERDOSE
Injury, poisoning and procedural complications
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0022 affected74 at risk
EG003
LIGAMENT RUPTURE
Injury, poisoning and procedural complications
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
FEMORAL NECK FRACTURE
Injury, poisoning and procedural complications
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
SPINAL COMPRESSION FRACTURE
Injury, poisoning and procedural complications
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
OSTEOARTHRITIS
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
CHEST PAIN
General disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0011 affected71 at risk
EG0021 affected74 at risk
EG003
UTERINE CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0011 affected71 at risk
EG0020 affected74 at risk
EG003
PANCREATIC CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0011 affected71 at risk
EG0020 affected74 at risk
EG003
HEPATIC CANCER METASTATIC
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0011 affected71 at risk
EG0020 affected74 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
HYPERTENSION
Vascular disorders
MedDRA 11.1
Systematic Assessment
EG0001 affected74 at risk
EG0014 affected71 at risk
EG0023 affected74 at risk
EG0033 affected74 at risk
EG0040 affected72 at risk
HEADACHE
Nervous system disorders
MedDRA 11.1
Systematic Assessment
EG0003 affected74 at risk
EG0012 affected71 at risk
EG0024 affected74 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0001 affected74 at risk
EG0014 affected71 at risk
EG0024 affected74 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0001 affected74 at risk
EG0011 affected71 at risk
EG0027 affected74 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0014 affected71 at risk
EG0023 affected74 at risk
EG003
RHINITIS
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0001 affected74 at risk
EG0014 affected71 at risk
EG0020 affected74 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0003 affected74 at risk
EG0015 affected71 at risk
EG0025 affected74 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0013 affected71 at risk
EG0021 affected74 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0003 affected74 at risk
EG0013 affected71 at risk
EG0023 affected74 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0002 affected74 at risk
EG0013 affected71 at risk
EG0024 affected74 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 11.1
Systematic Assessment
EG0007 affected74 at risk
EG00111 affected71 at risk
EG00211 affected74 at risk
EG003
JOINT INJURY
Injury, poisoning and procedural complications
MedDRA 11.1
Systematic Assessment
EG0000 affected74 at risk
EG0010 affected71 at risk
EG0020 affected74 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0003 affected74 at risk
EG0014 affected71 at risk
EG0023 affected74 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0003 affected74 at risk
EG0014 affected71 at risk
EG0022 affected74 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 11.1
Systematic Assessment
EG0001 affected74 at risk
EG0015 affected71 at risk
EG0022 affected74 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 11.1
Systematic Assessment
EG0002 affected74 at risk
EG0013 affected71 at risk
EG0023 affected74 at risk
EG003
ASTHENIA
General disorders
MedDRA 11.1
Systematic Assessment
EG0003 affected74 at risk
EG0014 affected71 at risk
EG0020 affected74 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 11.1
Systematic Assessment
EG0003 affected74 at risk
EG0012 affected71 at risk
EG0025 affected74 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Boaz Hirschberg
AstraZeneca Pharmaceuticals
ClinicalTrialTransparency@astrazeneca.com
ID
Term
D003920
Diabetes Mellitus
Ancestor Terms
ID
Term
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
C502994
saxagliptin
D008687
Metformin
Ancestor Terms
ID
Term
D001645
Biguanides
D006146
Guanidines
D000578
Amidines
D009930
Organic Chemicals
Browse Leaves
Not provided
Browse Branches
Not provided
5 subjects
6 subjects
4 subjects
3 subjects
1 subjects
1 subjects
0 subjects
0 subjects
55.11
± 10.35
BG00455.57± 10.32
BG00554.98± 10.31
34
BG00339
BG00439
BG005197
Male
BG00025
BG00138
BG00237
BG00333
BG00435
BG005168
68
7.79
± 0.112
Week 24 Mean
Title
Measurements
OG0007.30± 0.106
OG0017.27± 0.129
OG0027.37± 0.137
OG0037.57± 0.141
Adjusted Mean Change from Baseline
Title
Measurements
OG000-0.71± 0.103
OG001-0.66± 0.102
OG002-0.63± 0.102
OG003-0.26± 0.103
70
OG00168
Title
Denominators
Categories
Baseline Mean
Title
Measurements
OG0007.88± 0.111
OG0017.79± 0.112
Week 24 Mean
Title
Measurements
OG0007.29± 0.124
OG0017.57± 0.141
Adjusted Mean Change from Baseline
Title
Measurements
OG000-0.61± 0.101
OG001-0.26± 0.103
OG003
Saxagliptin 5 mg Once in the Evening (QPM)
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
OG004
Placebo
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
Units
Counts
Participants
OG00070
OG00171
OG00271
OG00371
OG00471
Title
Denominators
Categories
Baseline Mean
Title
Measurements
OG000156.6± 3.96
OG001162.2± 4.24
OG002170.6± 6.15
OG003159.6± 5.32
OG004158.6± 5.44
Week 24 Mean
Title
Measurements
OG000146.8± 3.79
OG001151.3± 5.88
OG002155.2± 5.88
OG003
Adjusted Mean Change from Baseline
Title
Measurements
OG000-11.4± 4.50
OG001-10.7± 4.46
OG002-12.5± 4.48
OG003
OG003
Saxagliptin 5 mg Once in the Evening (QPM)
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
OG004
Placebo
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
Units
Counts
Participants
OG00067
OG00169
OG00269
OG00370
OG00468
Title
Denominators
Categories
Title
Measurements
OG00035.8
OG00144.9
OG00243.5
OG00338.6
OG00435.3
OG003
Saxagliptin 5 mg Once in the Evening (QPM)
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
OG004
Placebo
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.