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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: |
NCT00295633 |
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Date of registration:
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22/02/2006 |
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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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A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy 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 Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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565 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00295633 |
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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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Canada
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India
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Mexico
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Peru
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Philippines
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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 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
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: rosiglitazone
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Drug: metformin
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Drug: pioglitazone
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Drug: Placebo
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Drug: Saxagliptin
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Primary Outcome(s)
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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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Percentage of Participants Achieving A1c <7% at Week 24
[Time Frame: Week 24]
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Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
[Time Frame: Baseline, Week 24]
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Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
[Time Frame: Baseline, Week 24]
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Secondary ID(s)
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CV181-013
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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