Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, Twice Daily, in Combination With Metformin IR in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin IR Alone
2 other identifiers
interventional
166
4 countries
41
Brief Summary
The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 type-2-diabetes-mellitus
Started May 2009
Shorter than P25 for phase_3 type-2-diabetes-mellitus
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2009
CompletedFirst Posted
Study publicly available on registry
April 22, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
December 16, 2011
CompletedJune 1, 2015
May 1, 2015
9 months
April 21, 2009
November 2, 2011
May 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12
Mean change was adjusted for baseline.
Baseline, Week 12
Secondary Outcomes (3)
Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)
Baseline, Week 12
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12
Week 12
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12
Week 12
Other Outcomes (8)
Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary
Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the double-blind (DB) period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.
Participants With Reported Hypoglycemia AEs During Double-Blind Treatment Period
Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.
Participants With Confirmed Hypoglycemia
Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.
- +5 more other outcomes
Study Arms (2)
Saxagliptin plus metformin IR
ACTIVE COMPARATORPlacebo plus metformin IR
PLACEBO COMPARATORInterventions
Tablets, Oral, 2.5 mg, Twice daily, 12 weeks
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- years of age
- Taking stable twice daily (BID) dosing of metformin IR (at least 1500 mg) for at least 8 weeks
- A1C: 7-10%
- C-peptide: ≥ 0.8 ng/mL
- Body mass index (BMI): ≤45 kg/m\^2
You may not qualify if:
- Women of childbearing potential unable or unwilling to use acceptable birth control
- Women who are pregnant or breastfeeding
- Fasting plasma glucose (FPG) \>270 mg/dL
- Significant cardiovascular history
- Symptoms of poorly controlled diabetes
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma
- Insulin therapy within one year of screening
- Cardiovascular even within the prior 6 months
- New York Heart Association Stage III/IV congestive heart failure and/or known left ventricular ejection fraction \<=40%
- Significant history of renal or hepatic disease
- History of a psychiatric disorder, alcohol or drug abuse within the previous year
- Treatment with potent CYP3A4 inhibitors or inducers
- Immunocompromised participants
- Active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (41)
John Muir Physician Network Clinical Research Center
Concord, California, 94520, United States
Southland Clinical Research Center, Inc.
Fountain Valley, California, 92708, United States
Torrance Clinical Research
Lomita, California, 90717, United States
Ritchken & First M.D.'S
San Diego, California, 92117, United States
Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, 32701, United States
Family Care Associates Of Nw Florida
Chipley, Florida, 32428, United States
Clinical Therapeutics Corporation
Coral Gables, Florida, 33134, United States
Nextphase Clinical Trials, Inc.
Miami, Florida, 33145, United States
Middle Georgia Drug Study Center, Llc
Perry, Georgia, 31069, United States
Louisiana Heart Center Research
Slidell, Louisiana, 70458, United States
Jackson Clinic
Rolling Fork, Mississippi, 39159, United States
Community Health Care Of Manchester
Akron, Ohio, 44319, United States
Midwest Regional Research, Inc.
Bellbrook, Ohio, 45305, United States
Wells Institute For Health Awareness
Kettering, Ohio, 45429, United States
Newark Physician Associates
Newark, Ohio, 43055, United States
Integris Family Care South
Oklahoma City, Oklahoma, 73170, United States
Integris Family Care Yukon
Yukon, Oklahoma, 73099, United States
Williamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
Integrated Medical Group Pc/Fleetwood Clinical Research
Fleetwood, Pennsylvania, 19522, United States
Southeastern Research Associates, Inc
Taylors, South Carolina, 29687, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Village Family Practice
Houston, Texas, 77024, United States
Southwest Clinical Research Centers, Llc
Pearland, Texas, 77584, United States
Jolene K. Berg, Md., Dgd Research, Inc.
San Antonio, Texas, 78229, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454, United States
Local Institution
Ludwigshafen, 67067, Germany
Local Institution
Magdeberg, 39112, Germany
Local Institution
Pirna, 01796, Germany
Local Institution
Saarbrücken, 66119, Germany
Local Institution
Saarlouis, 66740, Germany
Local Institution
Tann, 36142, Germany
Local Institution
Wüstensachsen, 36115, Germany
Local Institution
Balatonfüred, Hungary, 8230, Hungary
Local Institution
Budapest, 1036, Hungary
Local Institution
Eger, 3300, Hungary
Local Institution
Szigetvár, 7900, Hungary
Local Institution
Zalaegerszeg, 8900, Hungary
Local Institution
Ponce, 00716, Puerto Rico
Local Institution
San Juan, 00909, Puerto Rico
Local Institution
San Juan, 00920, Puerto Rico
Local Institution
San Juan, 00926, Puerto Rico
Related Publications (1)
White JL, Buchanan P, Li J, Frederich R. A randomized controlled trial of the efficacy and safety of twice-daily saxagliptin plus metformin combination therapy in patients with type 2 diabetes and inadequate glycemic control on metformin monotherapy. BMC Endocr Disord. 2014 Feb 24;14:17. doi: 10.1186/1472-6823-14-17.
PMID: 24565221DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boaz Hirschberg
- Organization
- AstraZeneca Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2009
First Posted
April 22, 2009
Study Start
May 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
June 1, 2015
Results First Posted
December 16, 2011
Record last verified: 2015-05