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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

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

NCT ID

Therapeutic Area

Tablets, Oral, once daily, up to 12 weeks

Tablets, Oral, 0 mg, once daily, up to 12 weeks

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

University Of Michigan

Diabetes And Glandular Disease Research Associates, P.A.

Mountain Diabetes And Endocrine Center

Endocrine Research Solutions, Inc.

Valley Research

Bernstein, Richard

Indiana University

Suny Upstate Medical University

Advanced Healthcare S.C.

Nea Clinic

St. Louis Center For Clinical Research

Research Institute Of Dallas, P.A.

Model Clinical Research Llc

Local Institution

Rainier Clinical Research  Center

Jacksonville Center For Clinical Research

Your Diabetes Endocrine Nutrition Group

A Pilot Study of the Efficacy and Safety of BMS-512148 on Glycemic Control in Subjects with Type 2 Diabetes Treated Aggressively but not Controlled on Combination Antihyperglycemic Therapy with Metformin and/or Thiazolidinedione (TZD) and Insulin.

Age Continuous

Age, Customized

Gender, Customized

Race/Ethnicity, Customized

All randomized patients who received at least 1 dose of study medication

Cohort 1 data provided information on insulin dose adjustment (n=4).

HbA1c was measured as percent of hemoglobin by a central laboratory. Data after insulin uptitration was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, and 12 in the double-blind period.

Chort 2 all randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.

Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2

Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Data after insulin uptitration was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, and 12 in the double-blind period.

Chort 2 all randomized participants who received study medication and had nonmissing FPG values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.

Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2

Therapeutic glycemic response is defined as HbA1c <7.0%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.

Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.

Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2

Therapeutic glycemic response is defined as HbA1c <=6.5%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.

Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2

Therapeutic glycemic response is defined as HbA1c decrease from baseline >= 0.5% at Week 12. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.

Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease from Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2

Baseline TDDI was reduced by 50% prior to treatment, except 2 subjects. TDDI could be up-titrated according to prespecified criteria at Weeks 4, 6, 8, 10 and 12 in the double-blind period.

Chort 2 all randomized participants who received study medication and had nonmissing TDDI values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin.

Arms	Assigned Interventions
Experimental: Cohort 1 20 mg	Drug: Dapagliflozin Tablets, Oral, once daily, up to 12 weeks Other Name: BMS-512148
Experimental: Cohort 2 - Arm 1 10 mg	Drug: Dapagliflozin Tablets, Oral, once daily, up to 12 weeks Other Name: BMS-512148
Experimental: Cohort 2 - Arm 2 20 mg	Drug: Dapagliflozin Tablets, Oral, once daily, up to 12 weeks Other Name: BMS-512148
Placebo Comparator: Cohort 2 - Arm 3	Drug: Placebo Tablets, Oral, 0 mg, once daily, up to 12 weeks

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

Official Title

Medical condition

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Healthy volunteers

Study drug

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Actual Enrollment

Study type

Age

Date

Study design

Verification:

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Documents available

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

Trial Results Summaries

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