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A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
AstraZeneca
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00263276
First received: December 7, 2005
Last updated: November 16, 2016
Last verified: November 2016
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Purpose
The purpose of this clinical research study is to learn if BMS-512148 is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnosed with Type 2 diabetes. Patients should first try to control their diabetes with diet and exercise and should not have previously been treated for their diabetes (very short periods of time are acceptable). The safety of BMS512148 will also be studied
| Condition | Intervention | Phase |
|---|---|---|
| Type 2 Diabetes | Drug: dapagliflozin Drug: placebo Drug: metformin | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-512148 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Treatment Naive And Have Inadequate Glycemic Control on Diet and Exercise |
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Mean change from baseline in HbA1c compared to placebo. [ Time Frame: at 12 weeks ]
Secondary Outcome Measures:
- Mean change from baseline in fasting plasma glucose, evaluate proportion of subjects who achieve a therapeutic response (HbA1c <7%); change from baseline in urinary glucose excretion [ Time Frame: at Weeks 6 and 12 ]
| Enrollment: | 389 |
| Study Start Date: | December 2005 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: dapagliflozin
Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
|
| Experimental: Arm 2 |
Drug: dapagliflozin
Tablets, Oral, 5 mg, Once daily, 12 weeks.
|
| Experimental: Arm 3 |
Drug: dapagliflozin
Tablets, Oral, 10 mg, Once daily, 12 weeks.
|
| Experimental: Arm 4 |
Drug: dapagliflozin
Tablets, Oral, 20 mg, Once daily, 12 weeks.
|
| Experimental: Arm 5 |
Drug: dapagliflozin
Tablets, Oral, 50 mg, Once daily, 12 weeks.
|
| Placebo Comparator: Arm 6 |
Drug: placebo
Tablets, Oral, 0 mg, Once daily, 12 weeks.
|
| Active Comparator: Arm 7 |
Drug: metformin
Tablets, Oral, >/= 1500 mg, Once daily, 12 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with Type 2 diabetes mellitus with inadequate glycemic control on diet and exercise. HbA1c >= 7% and <=10%.
- Patient either has not been previously treated with antihyperglycemic medication or has been treated for <30 days since diagnosis and has received less than 3 consecutive doses or 7 non-consecutive doses in the last 30 days.
- C-peptide > 1.0 ng/ml
- Body Mass Index <= 40 kg/m2
- Serum creatinine < 1.5 mg/dL for men or < 1.4 mg/dL for women.
- No overt proteinuria (microalbumin/creatinine ratio must be <300 mg/g
Exclusion Criteria:
- Unstable renal disease
- Patients with significant liver disease including chronic active hepatitis
- Within the last 6 months has had any of the following cardiovascular event: myocardial infarction, unstable angina, unstable CHF,NYHA Class III or IV CHF, TIA, unstable arrhythmia or cardiac revascularization surgery.
- Subjects with clinically significant anemia
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00263276
Show 145 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263276
Show 145 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00263276 History of Changes |
| Other Study ID Numbers: |
MB102-008 |
| Study First Received: | December 7, 2005 |
| Last Updated: | November 16, 2016 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on September 21, 2017