Evaluate Safety as Mono or Combination Therapies With Anti-diabetes Mellitus Drugs in Japanese Subjects With Type 2 Diabetes Mellitus

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type2 Diabetes; High Blood Sugar

Treatments: Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01294436

D1692C00012

Details and patient eligibility

About

This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.

Enrollment: 728 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 type2 DM ; ≥6.5% and ≤10% at 1 week before treatment started

Exclusion criteria

• Type 1 diabetes mellitus,
• FPG >240 mg/dL before treatment started
• 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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728 participants in 1 patient group

Open label treatment

Experimental group

Treatment:

Drug: Dapagliflozin