Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients

Study Overview
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Brief Summary
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This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

Official Title
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A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: dapagliflozin
* Drug: glipizide
* Drug: metformin hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 Diabetes Treated with oral anti-diabetic drug therapy therapy including Metformin for at least 8 weeks prior to enrolment HbA1c >6.5% and </=10% Exclusion Criteria: Type 1 Diabetes Insulin therapy within one year of enrolment Renal (kidney) failure or dysfunction

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: 1<br>dapagliflozin plus metformin | Drug: dapagliflozin<br>* Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks<br>Drug: metformin hydrochloride<br>* Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks<br>* Other names: Glucophage;|
| Active Comparator: 2<br>glipizide plus metformin | Drug: glipizide<br>* Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks<br>* Other names: Glucotrol;Drug: metformin hydrochloride<br>* Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks<br>* Other names: Glucophage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change in HbA1c Levels | To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone. | Baseline to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change in Body Weight | To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment. | Baseline to Week 52 | 
| Proportion of Participants With at Least One Episode of Hypoglycemia | To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value. | Baseline to Week 52 | 
| Proportion of Participants With Body Weight Reduction of at Least 5% | To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value. | Baseline to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dapagliflozin, efficacy, safety, metformin, Type 2 diabetes