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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: |
NCT00121667 |
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Date of registration:
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18/07/2005 |
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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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Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone
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Scientific title:
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"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone" |
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Date of first enrolment:
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August 2005 |
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Target sample size:
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1462 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00121667 |
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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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Argentina
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Australia
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Brazil
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Canada
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Chile
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Mexico
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Puerto Rico
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Taiwan
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater
than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks
prior to screening.
- HbA1c >= 7.0% and <= 10.0 %
- Body mass index <= 40 kg/m2
- Fasting C-peptide >= 1 ng/dL
Exclusion Criteria:
- Symptomatic poorly controlled diabetes
- Recent cardiac or cerebrovascular event
- Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for females
Age minimum:
18 Years
Age maximum:
77 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: Pioglitazone
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Drug: Saxagliptin + Metformin
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Drug: Placebo + Metformin
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Primary Outcome(s)
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Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24
[Time Frame: Baseline, Week 24]
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Secondary Outcome(s)
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Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
[Time Frame: Baseline, Week 24]
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Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24
[Time Frame: Week 24]
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Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)
[Time Frame: Baseline, Week 24]
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Secondary ID(s)
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CV181-014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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