A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes

AstraZeneca

Status and phase: Completed; Phase 3; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00357370

MB102-009

Details and patient eligibility

About

The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. The safety of this treatment will also be studied.

Enrollment: 163 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females, 18 to 75 years old, with type 2 diabetes with inadequate glycemic control
• Subjects receiving insulin and metformin and/or a thiazolidinedione
• Body Mass Index <=45.0 kg/m2
• Serum creatinine <1.5 mg/dL for men or <1.4 mg/dL for women
• No overt proteinuria (in subjects with a microalbumin/creatinine ratio ≥300 mg/g, the 24-hour urinary excretion of total protein must be <3 g/24 hrs)

Exclusion criteria

• History of type 1 diabetes
• AST and/or ALT >2.5 times the upper limit of normal
• Creatinine kinase ≥3 times the upper limit of normal
• Symptoms of severely uncontrolled diabetes
• History of hypoglycemic unawareness
• Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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163 participants in 4 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

20 mg

Treatment:

Drug: Dapagliflozin

Cohort 2 - Arm 1

Experimental group

Description:

10 mg

Treatment:

Drug: Dapagliflozin

Cohort 2 - Arm 2

Experimental group

Description:

20 mg

Treatment:

Drug: Dapagliflozin

Cohort 2 - Arm 3

Placebo Comparator group

Treatment:

Drug: Placebo