Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea

Study Overview
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Brief Summary
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This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.

Official Title
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A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and Sulfonylurea

Conditions
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Type 2 Diabetes Mellitus, High HbA1c Level, Inadequate Glycaemic Control

Intervention / Treatment
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* Drug: dapagliflozin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus Men or women age ≥ 18 years old Stable dose combination of metformin and sulfonylurea HbA1c ≥7.7% and ≤11.0% Exclusion Criteria: Type 1 diabetes mellitus or diabetes insipidus Recent cardiovascular events Kidney or urological disorders Hepatic disorders

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: Dapagliflozin 10 mg tablet<br> | Drug: dapagliflozin<br>* 10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period<br>|
| Placebo Comparator: matching placebo tablet<br> | Drug: placebo<br>* matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change From Baseline in HbA1c Levels | To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea. | Baseline to week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change From Baseline in FPG | To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo | Baseline to week 24 | 
| Adjusted Mean Change From Baseline in Total Body Weight | To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo | Baseline to week 24 | 
| Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF) | To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo | Baseline to week 24 | 
| Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure | To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo | Baseline to week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dapagliflozin, diabetes, hyperglycaemia