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

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes	Drug: dapagliflozin; Drug: placebo; Drug: metformin	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	389 participants
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
Study Start Date :	December 2005
Actual Primary Completion Date :	February 2007
Actual Study Completion Date :	February 2007

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Mean change from baseline in HbA1c compared to placebo. [ Time Frame: at 12 weeks ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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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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  Show 145 Study Locations

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

Study Director:	Bristol Myers Squibb	Bristol-Myers Squibb

More Information

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Additional Information:

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm 

MB102-008 _CSR_synopsis 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

List JF, Woo V, Morales E, Tang W, Fiedorek FT. Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Diabetes Care. 2009 Apr;32(4):650-7. doi: 10.2337/dc08-1863. Epub 2008 Dec 29.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00263276 History of Changes
Other Study ID Numbers:	MB102-008
First Posted:	December 8, 2005
Last Update Posted:	November 17, 2016
Last Verified:	November 2016

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases