Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Dapagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00972244

D1692C00005

Details and patient eligibility

About

The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses.

Enrollment: 417 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese Subjects with type 2 diabetes mellitus.
• Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c ≤ 8%.
• Provision of informed consent.

Exclusion criteria

• Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
• The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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417 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

1mg dapagliflozin

Treatment:

Drug: Dapagliflozin

2

Experimental group

Description:

2.5mg dapagliflozin

Treatment:

Drug: Dapagliflozin

3

Experimental group

Description:

5mg dapagliflozin

Treatment:

Drug: Dapagliflozin

4

Experimental group

Description:

10mg dapagliflozin

Treatment:

Drug: Dapagliflozin

5

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo