Back to resultsA Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Saxagliptin
Saxagliptin
Placebo
pioglitazone
rosiglitazone
metformin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria: Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening. Hemoglobin A1c (HbA1c) > = 7.0% and < = 10.5% Body mass index < = 45kg/m2 Fasting C-peptide > = 1 ng/mL Exclusion Criteria: Symptomatic poorly controlled diabetes Recent cardiac or cerebrovascular event Serum creatinine > = 2.0 mg/dL
Sites / Locations
- Winston Technology, Inc.
- Sunbelt Research Group, Llc
- Iicr, Inc.
- Clinical Research Advantage, Inc
- Nea Clinic
- Little Rock Family Practice Clinic
- Impact Clinical Trials
- Lovelace Scientific Resources, Inc.
- Medical Group Of Encino
- Marin Endocrine Care And Research, Inc.
- Del Rosario Medical Clinic, Inc.
- Loma Linda Va Healthcare Systems
- Peak Health Medical Group
- Richard Cherlin, Md
- Mission Internal Medical Group
- Desert Medical Advances
- Denver Internal Medicine Group
- Stamford Therapeutics Consortium
- Phoenix Internal Medicine Associates, Llc
- Central Florida Clinical Trials, Inc.
- Southern Family Healthcare, Pa
- Doctors Medical Center Of Walton County
- Horizon Institute For Clinical Research
- Jacksonville Center For Clinical Research
- Panhandle Family Care Associates
- Nextphase Clinical Trials, Inc
- Baptist Diabetes Associates
- Heart & Vascular Center Research, Inc.
- Alan B. Miller, Md
- Marietta Clinical Research, Inc.
- Endocrine Research Solutions, Inc.
- D. Thomas Rogers, Md, Facs
- Southeast Idaho Family Practice
- Cedar-Crosse Research Center
- Physicians Research Group
- Northwest Indiana Center For Clinical Research
- Lipid Research Clinic
- Professional Research Network Of Kansas
- Mouhaffel, Assad H.
- Promed Physicians Family Practice
- Olive Branch Family Medical Center
- Radiant Research Las Vegas
- Nevada Alliance Against Diabetes
- Office Of Ammar Bazerbashi, Md
- Urgentmed, P.C.
- Medical Research Associates Of Charlotte, Inc.
- Carolina Pharmaceutical Research
- Community Health Care
- Clinical Research Limited
- Rapid Medical Research, Inc.
- Providence Health Partners - Center For Clinical Research
- Holzer Clinic
- Wells Institute For Health Awareness
- David Witkin, Md
- Harleysville Medical Associates
- Family Medical Associates
- Banksville Medical Pc
- Three Rivers Medical Associates, Pa
- Radiant Research, Greer
- Upstate Pharmaceutical Research
- East Tennessee Medical Group
- Healthstar Physicians
- Hayes Endocrine And Diabetes Center
- Capital Medical Clinic, Llp
- Texas Diabetes And Endocrinology, P.A.
- Radiant Research-Austin
- Priscilla Hollander, Md, Phd
- The Medical Group Of Texas
- Mobley Research Center
- Family Physician, Pa
- Mapleridge Medical Center
- Diabetes Center Of The Southwest
- Pearland Primary Care Associates, Llp
- Med-Cure
- Radiant Research San Antonio
- S.A.M. Clinical Research Center
- Collom And Carney Clinic
- National Clinical Research, Inc.
- Tidewater Integrated Medical Research
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
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- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
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- Local Institution
- Local Institution
- Local Institution
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- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Saxagliptin plus open-label TZD (A)
Saxagliptin plus open-label TZD (B)
Placebo plus open-label TZD (C)
Arm Description
Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Outcomes
Primary Outcome Measures
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Secondary Outcome Measures
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Percentage of Participants Achieving A1c <7% at Week 24
Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD at 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 achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00295633
Brief Title
A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
Official Title
A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone
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 (defined as rescue medication) added onto their blinded study medication
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
565 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saxagliptin plus open-label TZD (A)
Arm Type
Experimental
Arm Description
Saxagliptin PLUS pioglitazone OR rosiglitazone
PLUS open-label metformin (as needed as rescue medication)
Arm Title
Saxagliptin plus open-label TZD (B)
Arm Type
Experimental
Arm Description
Saxagliptin PLUS pioglitazone OR rosiglitazone
PLUS open-label metformin (as needed as rescue medication)
Arm Title
Placebo plus open-label TZD (C)
Arm Type
Placebo Comparator
Arm Description
Placebo PLUS pioglitazone OR rosiglitazone
PLUS open-label metformin (as needed as rescue medication)
Intervention Type
Drug
Intervention Name(s)
Saxagliptin
Other Intervention Name(s)
BMS-477118
Intervention Description
Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT)
Intervention Type
Drug
Intervention Name(s)
Saxagliptin
Other Intervention Name(s)
BMS-477118
Intervention Description
Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT)
Intervention Type
Drug
Intervention Name(s)
pioglitazone
Intervention Description
Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT)
Intervention Type
Drug
Intervention Name(s)
rosiglitazone
Intervention Description
Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT)
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
Tablets, Oral, 500-2500 mg, as needed (12 months LT)
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Description
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Description
Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Time Frame
Baseline, Week 24
Title
Percentage of Participants Achieving A1c <7% at Week 24
Description
Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24.
Time Frame
Week 24
Title
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
Description
Mean change from baseline for 0 to 180 minutes PPG AUC achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value.
Time Frame
Baseline, Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening.
Hemoglobin A1c (HbA1c) > = 7.0% and < = 10.5%
Body mass index < = 45kg/m2
Fasting C-peptide > = 1 ng/mL
Exclusion Criteria:
Symptomatic poorly controlled diabetes
Recent cardiac or cerebrovascular event
Serum creatinine > = 2.0 mg/dL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Winston Technology, Inc.
City
Haleyville
State/Province
Alabama
ZIP/Postal Code
35565
Country
United States
Facility Name
Sunbelt Research Group, Llc
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36606
Country
United States
Facility Name
Iicr, Inc.
City
Ozark
State/Province
Alabama
ZIP/Postal Code
36360
Country
United States
Facility Name
Clinical Research Advantage, Inc
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Nea Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Little Rock Family Practice Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Impact Clinical Trials
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Medical Group Of Encino
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Marin Endocrine Care And Research, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Del Rosario Medical Clinic, Inc.
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Loma Linda Va Healthcare Systems
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
Peak Health Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Richard Cherlin, Md
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Mission Internal Medical Group
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Denver Internal Medicine Group
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Phoenix Internal Medicine Associates, Llc
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Central Florida Clinical Trials, Inc.
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32714
Country
United States
Facility Name
Southern Family Healthcare, Pa
City
Chipley
State/Province
Florida
ZIP/Postal Code
32428
Country
United States
Facility Name
Doctors Medical Center Of Walton County
City
Defuniak Springs
State/Province
Florida
ZIP/Postal Code
32435
Country
United States
Facility Name
Horizon Institute For Clinical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Jacksonville Center For Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Panhandle Family Care Associates
City
Marianna
State/Province
Florida
ZIP/Postal Code
32446
Country
United States
Facility Name
Nextphase Clinical Trials, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Baptist Diabetes Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Heart & Vascular Center Research, Inc.
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Alan B. Miller, Md
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Marietta Clinical Research, Inc.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Endocrine Research Solutions, Inc.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
D. Thomas Rogers, Md, Facs
City
Kahului
State/Province
Hawaii
ZIP/Postal Code
96732
Country
United States
Facility Name
Southeast Idaho Family Practice
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Cedar-Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Physicians Research Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Northwest Indiana Center For Clinical Research
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Lipid Research Clinic
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Professional Research Network Of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Mouhaffel, Assad H.
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Promed Physicians Family Practice
City
Portage
State/Province
Michigan
ZIP/Postal Code
49024
Country
United States
Facility Name
Olive Branch Family Medical Center
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Radiant Research Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
Facility Name
Nevada Alliance Against Diabetes
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
Office Of Ammar Bazerbashi, Md
City
Holmdel
State/Province
New Jersey
ZIP/Postal Code
07733
Country
United States
Facility Name
Urgentmed, P.C.
City
South Bound Brook
State/Province
New Jersey
ZIP/Postal Code
08880
Country
United States
Facility Name
Medical Research Associates Of Charlotte, Inc.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Carolina Pharmaceutical Research
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Community Health Care
City
Canal Fulton
State/Province
Ohio
ZIP/Postal Code
44614
Country
United States
Facility Name
Clinical Research Limited
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Providence Health Partners - Center For Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Holzer Clinic
City
Gallipolis
State/Province
Ohio
ZIP/Postal Code
45631
Country
United States
Facility Name
Wells Institute For Health Awareness
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
David Witkin, Md
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Harleysville Medical Associates
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
Facility Name
Family Medical Associates
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
Banksville Medical Pc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15216
Country
United States
Facility Name
Three Rivers Medical Associates, Pa
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Radiant Research, Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Upstate Pharmaceutical Research
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
East Tennessee Medical Group
City
Alcoa
State/Province
Tennessee
ZIP/Postal Code
37701
Country
United States
Facility Name
Healthstar Physicians
City
Morristown
State/Province
Tennessee
ZIP/Postal Code
37813
Country
United States
Facility Name
Hayes Endocrine And Diabetes Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Capital Medical Clinic, Llp
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Diabetes And Endocrinology, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Radiant Research-Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78752
Country
United States
Facility Name
Priscilla Hollander, Md, Phd
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The Medical Group Of Texas
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Mobley Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Family Physician, Pa
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Mapleridge Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Diabetes Center Of The Southwest
City
Midland
State/Province
Texas
ZIP/Postal Code
79705
Country
United States
Facility Name
Pearland Primary Care Associates, Llp
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Med-Cure
City
Rosenberg
State/Province
Texas
ZIP/Postal Code
77471
Country
United States
Facility Name
Radiant Research San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
S.A.M. Clinical Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Collom And Carney Clinic
City
Texarkana
State/Province
Texas
ZIP/Postal Code
75503
Country
United States
Facility Name
National Clinical Research, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Tidewater Integrated Medical Research
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23451
Country
United States
Facility Name
Local Institution
City
Belgrano
State/Province
Buenos Aires
ZIP/Postal Code
C1426EGP
Country
Argentina
Facility Name
Local Institution
City
Chacabuco
State/Province
Buenos Aires
ZIP/Postal Code
B6740CWC
Country
Argentina
Facility Name
Local Institution
City
Ciudad Auton.
State/Province
Buenos Aires
ZIP/Postal Code
C1505CWB
Country
Argentina
Facility Name
Local Institution
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Local Institution
City
Moron
State/Province
Buenos Aires
ZIP/Postal Code
B17081FF
Country
Argentina
Facility Name
Local Institution
City
Ciudad De Mendoza
State/Province
Mendoza
ZIP/Postal Code
M5519XAC
Country
Argentina
Facility Name
Local Institution
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000CVD
Country
Argentina
Facility Name
Local Institution
City
Lanus Este
State/Province
Tucuman
ZIP/Postal Code
1824
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
C1408INH
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Local Institution
City
St. Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1E 2C2
Country
Canada
Facility Name
Local Institution
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Local Institution
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Local Institution
City
St Catharines
State/Province
Ontario
ZIP/Postal Code
L2R 7P3
Country
Canada
Facility Name
Local Institution
City
St-Leonard
State/Province
Quebec
ZIP/Postal Code
H1S 3A9
Country
Canada
Facility Name
Local Institution
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Local Institution
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 3H3
Country
Canada
Facility Name
Local Institution
City
Bangalore
ZIP/Postal Code
560010
Country
India
Facility Name
Local Institution
City
Bangalore
ZIP/Postal Code
560054
Country
India
Facility Name
Local Institution
City
Chennai
ZIP/Postal Code
600010
Country
India
Facility Name
Local Institution
City
Chennai
ZIP/Postal Code
600013
Country
India
Facility Name
Local Institution
City
Chennai
ZIP/Postal Code
600086
Country
India
Facility Name
Local Institution
City
Chennai
ZIP/Postal Code
680004
Country
India
Facility Name
Local Institution
City
Hariyana
ZIP/Postal Code
132001
Country
India
Facility Name
Local Institution
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
Local Institution
City
Indore
ZIP/Postal Code
452001
Country
India
Facility Name
Local Institution
City
Maharashtra
ZIP/Postal Code
411011
Country
India
Facility Name
Local Institution
City
Mangalore
ZIP/Postal Code
575001
Country
India
Facility Name
Local Institution
City
Mumbai
ZIP/Postal Code
400021
Country
India
Facility Name
Local Institution
City
Mumbai
ZIP/Postal Code
400067
Country
India
Facility Name
Local Institution
City
Pune
ZIP/Postal Code
411011
Country
India
Facility Name
Local Institution
City
Vellore
ZIP/Postal Code
632004
Country
India
Facility Name
Local Institution
City
Chichuahua
State/Province
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Local Institution
City
Angeles Del Pedregal
State/Province
Distrito Federal
ZIP/Postal Code
10700
Country
Mexico
Facility Name
Local Institution
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45200
Country
Mexico
Facility Name
Local Institution
City
Michoacan
State/Province
Morelos
ZIP/Postal Code
58000
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
66260
Country
Mexico
Facility Name
Local Institution
City
Aguascalientes
ZIP/Postal Code
20232
Country
Mexico
Facility Name
Local Institution
City
Cercado De Lima
State/Province
Lima
ZIP/Postal Code
1
Country
Peru
Facility Name
Local Institution
City
La Victoria
State/Province
Lima
ZIP/Postal Code
13
Country
Peru
Facility Name
Local Institution
City
Miraflores
State/Province
Lima
ZIP/Postal Code
18
Country
Peru
Facility Name
Local Institution
City
San Isidro
State/Province
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Local Institution
City
San Martin De Porres
State/Province
Lima
ZIP/Postal Code
31
Country
Peru
Facility Name
Local Institution
City
Santiago De Surco
State/Province
Lima
ZIP/Postal Code
33
Country
Peru
Facility Name
Local Institution
City
Cebu City
ZIP/Postal Code
1600
Country
Philippines
Facility Name
Local Institution
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Local Institution
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Local Institution
City
Las Pinas
ZIP/Postal Code
1740
Country
Philippines
Facility Name
Local Institution
City
Pasig City
ZIP/Postal Code
1600
Country
Philippines
Facility Name
Local Institution
City
Carolina
ZIP/Postal Code
00983
Country
Puerto Rico
Facility Name
Local Institution
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Local Institution
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Local Institution
City
Rio Piedras
ZIP/Postal Code
00926
Country
Puerto Rico
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00920
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
19864452
Citation
Hollander P, Li J, Allen E, Chen R; CV181-013 Investigators. Saxagliptin added to a thiazolidinedione improves glycemic control in patients with type 2 diabetes and inadequate control on thiazolidinedione alone. J Clin Endocrinol Metab. 2009 Dec;94(12):4810-9. doi: 10.1210/jc.2009-0550. Epub 2009 Oct 28.
Results Reference
background
PubMed Identifier
27402391
Citation
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.
Results Reference
derived
PubMed Identifier
27033025
Citation
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.
Results Reference
derived
PubMed Identifier
23795975
Citation
Karyekar CS, Frederich R, Ravichandran S. Clinically relevant reductions in HbA1c without hypoglycaemia: results across four studies of saxagliptin. Int J Clin Pract. 2013 Aug;67(8):759-67. doi: 10.1111/ijcp.12212. Epub 2013 Jun 24.
Results Reference
derived
PubMed Identifier
21680990
Citation
Karyekar C, Donovan M, Allen E, Fleming D, Ravichandran S, Chen R. Efficacy and safety of saxagliptin combination therapy in US patients with type 2 diabetes. Postgrad Med. 2011 Jul;123(4):63-70. doi: 10.3810/pgm.2011.07.2305.
Results Reference
derived
PubMed Identifier
21562064
Citation
Hollander PL, Li J, Frederich R, Allen E, Chen R; CV181013 Investigators. Safety and efficacy of saxagliptin added to thiazolidinedione over 76 weeks in patients with type 2 diabetes mellitus. Diab Vasc Dis Res. 2011 Apr;8(2):125-35. doi: 10.1177/1479164111404575.
Results Reference
derived
Learn more about this trial
A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
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