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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 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied

Add-on to Thiazolidinedione (TZD) Failures

NCT ID

Therapeutic Area

Tablets, Oral, 5.0 mg, once daily, up to 48 weeks

Tablets, Oral, 10.0 mg, once daily, up to 48 weeks

Tablets, Oral, 0 mg, once daily, up to 48 weeks

Tablets, ≥ 30 mg, Once daily, up to 48 weeks

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

Local Institution

The Center For Nutrition & Preventive Medicine, Pllc

Diabetes Medical Center Of California

Banksville Medical, Pc

Ritchken & First M.D.'S

Suncoast Clinical Res Inc.

William L. Gray, Md

New Hanover Medical Research

Clinical Therapeutics Corporation

Providence Health Partners - Center For Clinical Research

Little Rock Family Practice Clinic

Dallas Diabetes & Endocrine Center

Diabetes & Glandular Disease Research Assoc,, Inc.

Clinical Research Advantage Inc / Desert Clinical Res, Llc

Westside Center For Clinical Research

Marin Endocrine Care And Research, Inc.

Panhandle Family Care Associates

Finger Lakes Clinical Research

43rd Medical Associates, P.C.

Village Family Practice

Pinnacle Research Group, Llc

Desert Medical Advances

Olive Branch Family Medical Center

Association Of International Professionals

Diabetes Research Center

Endocrine Research Associates

Torrance Clinical Research

Physicians Research Center

Health First Clinical Research Group, Inc.

Professional Research Network Of Kansas

Iicr

Denver Internal Medicine

Southeastern Research Associates, Inc.

Family Medical Associates

Brookside Family Practice & Pediatrics

Encompass Clinical Research

Clinical Research Advantage, Inc

Clinical Innovations, Inc.

Holston Medical Group

Northwest Indiana Center For Clinical Research

Sierra Clinical Research

Central Florida Clinical Trials

Aurora Family Medicine Center, P.C.

Northstate Clinical Research

Randall Shue, D.O.

Baptist Diabetes Associates, Pa

Metrolina Internal Medicine

St. Mary'S Center For Diabetes And Endocrinology

Columbia Clinical Research, Inc.

Cedar Crosse Research Center

Office Of Dr. Michelle Zaniewski Singh

Advantage Clinical Research

Searcy  Medical Center

Avastra Clinical Trials

Physician Research, Inc.

Stone Mountain Clinical Research

Danny W. Jackson P.A.

Tidewater Integrated Medical Research

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination with Thiazolidinedione Therapy in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone

Age Continuous

Age, Customized

Gender, Male/Female

Race/Ethnicity, Customized

All randomized patients who received at least one dose of study medication.

HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication 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, 8, 12, 16, 20, and 24 in the double-blind period.

All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)

Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. In post oral glucose tolerance test (OGTT), glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. 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. PPG measurements were obtained on Day 1 and week 24 in the double-blind period.

Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication 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. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.

All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)

Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. 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, 8, 12, 16, 20, and 24 in the double-blind period.

All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)

Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants were estimated by modified logistic regression model.

All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)

Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in waist circumference at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication 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. Waist circumference measurements were obtained during the qualification and lead-in periods and on Day 1 and Week 24 of the double-blind period.

All randomized participants who received study medication and had nonmissing waist circumference values at baseline and Week 24 (LOCF)

Adjusted Mean Change From Baseline in Waist Circumference (cm) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight among subjects with baseline body mass index (BMI) ≥ 27 kg/m^2 at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication 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. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.

All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF) among subjects with baseline body mass index (BMI) ≥ 27 kg/m^2

Adjusted Mean Change From Baseline in Total Body Weight (kg) among subjects with baseline body mass index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Dapagliflozin Tablets, Oral, 5.0 mg, once daily, up to 48 weeks Other Name: BMS-512148 Drug: Thiazolidinedione (Pioglitazone) Tablets, ≥ 30 mg, Once daily, up to 48 weeks
Experimental: Arm 2	Drug: Dapagliflozin Tablets, Oral, 10.0 mg, once daily, up to 48 weeks Other Name: BMS-512148 Drug: Thiazolidinedione (Pioglitazone) Tablets, ≥ 30 mg, Once daily, up to 48 weeks
Placebo Comparator: Arm 3	Drug: Placebo matching Dapagliflozin Tablets, Oral, 0 mg, once daily, up to 48 weeks Drug: Thiazolidinedione (Pioglitazone) Tablets, ≥ 30 mg, Once daily, up to 48 weeks

Add-on to Thiazolidinedione (TZD) Failures

Official Title

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Documents available

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

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