A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: dapagliflozin; Drug: placebo; Drug: metformin

• Registration Number: NCT00263276
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-07
• Study First Submitted QC: 2005-12-07
• Study First Posted: 2005-12-08
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	dapagliflozin	-
Arm 2	dapagliflozin	-
Arm 3	dapagliflozin	-
Arm 5	dapagliflozin	-
Arm 6	placebo	-
Arm 7	metformin	-
Arm 4	dapagliflozin	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in HbA1c compared to placebo.	at 12 weeks

Secondary Outcome Measures

Name	Time	Method
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	at Weeks 6 and 12

Trial Locations

Locations (5)

Local Institution; 🇵🇷 San Juan, Puerto Rico

Local institution; 🇨🇦 Bathurst, New Brunswick, Canada

Local Insitution; 🇺🇸 Edina, Minnesota, United States

Local Instiuttion; 🇺🇸 Jacksonville, Florida, United States

Local Instiution; 🇺🇸 New Hyde Park, New York, United States