Status:
COMPLETED
Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Type 2 diabetes
- 18-78 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00885378
Start Date
May 1 2009
End Date
February 1 2010
Last Update
June 1 2015
Active Locations (41)
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1
John Muir Physician Network Clinical Research Center
Concord, California, United States, 94520
2
Southland Clinical Research Center, Inc.
Fountain Valley, California, United States, 92708
3
Torrance Clinical Research
Lomita, California, United States, 90717
4
Ritchken & First M.D.'S
San Diego, California, United States, 92117