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

AstraZeneca182 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

182

Conditions

Type 2 Diabetes Mellitus

Interventions

DapagliflozinDRUG

Tablet oral 10 mg total daily dose once daily 102 weeks

MetforminDRUG

Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks

SitagliptinDRUG

Tablet oral 100 mg total daily dose once daily rescue medication

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (21)

Research Site

Blagoevgrad, Bulgaria

Research Site

Sofia, Bulgaria

Research Site

Beroun, Czechia

Outcomes

Primary Outcomes

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.

Time frame: Baseline to Week 24

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to Week 24

Data from ClinicalTrials.gov

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