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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00885378 |
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Date of registration:
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21/04/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus
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Scientific title:
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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 |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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166 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00885378 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Germany
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Hungary
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Mexico
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Puerto Rico
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United States
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
78 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Intervention(s)
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Drug: Saxagliptin plus metformin IR
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Drug: Placebo plus metformin IR
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Primary Outcome(s)
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Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12
[Time Frame: Baseline, Week 12]
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Secondary Outcome(s)
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Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12
[Time Frame: Week 12]
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Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)
[Time Frame: Baseline, Week 12]
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Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12
[Time Frame: Week 12]
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Secondary ID(s)
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EUDRACT #: 2009-010224-25
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CV181-080
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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