Phase III Insulin Add-On Asia Regional Program - ST

Study Overview
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Brief Summary
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The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.

Official Title
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A 24-week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate Efficacy and Safety of Dapagliflozin Added to Therapy of Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Dapagliflozin
* Drug: Dapagliflozin Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have type 2 diabetes with inadequate glycemic control, defined as HbA1c ≥ 7.5% and ≤ 11.0% obtained at screening visit Subjects must be taking a stable mean dose of ≥ 20 IU injectable insulin daily for at least 8 weeks prior to enrollment Inclusion criteria for randomization: HbA1c ≥ 7.5 and ≤ 10.5% at Day -14 Exclusion Criteria: Treatment with more than two oral antidiabetic (OAD) agents within 6 weeks of Enrollment History of diabetic ketoacidosis of hyperosmolar nonketotic coma Clinically diagnosed Type 1 diabetes mellitus Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV Severe uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg History of unstable or rapidly progressing renal disease History of severe hepatobiliary disease Mallingancy within 5 years of the screening/enrollment visit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Dapagliflozin<br>Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin | Drug: Dapagliflozin<br>* Tablet<br>* Other names: BMS-512148;|
| Placebo Comparator: Group 2: Dapagliflozin Placebo<br>Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin | Drug: Dapagliflozin Placebo<br>* Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change in HbA1c From Baseline to Week 24 | The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm. | Baseline (Day 1) and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 | The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) was reported for each arm in milligrams per deciliter (mg/dL). | Baseline (Day 1) and 24 weeks | 
| Adjusted Mean Change in Body Weight From Baseline to Week 24 | Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg). | Baseline (Day 1) and 24 weeks | 
| Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24 | The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 was reported for each arm in International Units (IU). | Baseline (Day 1) and 24 weeks |