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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: dapagliflozin; Drug: glipizide; Drug: metformin hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00660907

D1690C00004

Details and patient eligibility

About

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.

Enrollment: 1,217 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,217 participants in 2 patient groups

1

Experimental group

Description:

dapagliflozin plus metformin

Treatment:

Drug: metformin hydrochloride

Drug: dapagliflozin

2

Active Comparator group

Description:

glipizide plus metformin

Treatment:

Drug: metformin hydrochloride

Drug: glipizide