Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.

Official Title
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A 24-week,Multi-centre,Int.,Double-blind,Rand.,Parallel-group,Plac.-Controlled,Phase III Study With a 78-week Ext.Per. to Evaluate the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

Conditions
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Type 2 Diabetes Mellitus

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Ongoing treatment with metformin on a stable dose of ≥1500 mg/day for at least 12 weeks prior to enrolment Inadequate glycemic control, defined as HbA1c ≥6.5% and ≤8.5% ≥30 years for males ≥55 years for females Exclusion Criteria: Type 1 Diabetes Body weight change >5% within 3 months prior to enrolment Renal and liver impairment

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Dapagliflozin 10 mg plus Metformin | Drug: Dapagliflozin<br>* Tablet oral 10 mg total daily dose once daily 102 weeks<br>Drug: Metformin<br>* Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks<br>Drug: Sitagliptin<br>* Tablet oral 100 mg total daily dose once daily rescue medication<br>|
| Placebo Comparator: B<br>Placebo plus Metformin | Drug: Metformin<br>* Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks<br>Drug: Sitagliptin<br>* Tablet oral 100 mg total daily dose once daily rescue medication<br>Drug: Placebo<br>* Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change in Total Body Weight | To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment. | Baseline to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change in Waist Circumference | To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference. | Baseline to Week 24 | 
| Adjusted Mean Change in Body Fat Mass | To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry. | Baseline to Week 24 | 
| Proportion of Participants With Body Weight Decrease ≥5% | To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease ≥5%. Least Squares Mean represents the percent of participants adjusted for body weight baseline value. | Baseline to Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dapagliflozin, Metformin, Type 2 diabetes, body weight