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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Sitagliptin; Drug: Metformin; Drug: Placebo; Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00855166

D1690C00012

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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182 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Dapagliflozin 10 mg plus Metformin

Treatment:

Drug: Metformin

Drug: Dapagliflozin

Drug: Sitagliptin

B

Placebo Comparator group

Description:

Placebo plus Metformin

Treatment:

Drug: Metformin

Drug: Placebo

Drug: Sitagliptin