Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: High Blood Sugar; Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01294423

D1692C00006

Details and patient eligibility

About

This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.

Enrollment: 261 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of informed consent prior to any study specific procedures
• Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)diagnosed with type 2 DM ; ≥6.5% and ≤10% at 1 week before randomization

Exclusion criteria

• Type 1 diabetes mellitus
• FPG >240 mg/dL before randomization
• Subjects who have history of unstable or rapidly progressing renal disease
• Subjects who have severe hepatic insufficiency and/or significant abnormal liver function
• Significant cardiovascular history

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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261 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Dapagliflozin 5 mg

Treatment:

Drug: Dapagliflozin

Drug: Dapagliflozin

2

Experimental group

Description:

Dapagliflozin 10 mg

Treatment:

Drug: Dapagliflozin

Drug: Dapagliflozin

3

Placebo Comparator group

Treatment:

Drug: Placebo