To Study Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1656 in Japanese Type 2 Diabetes Mellitus (T2DM) Patients (JMAD)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: AZD1656

Study type: Interventional

Funder types: Industry

Identifiers

NCT00916604

D1020C00004

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of AZD1656 after multiple repeated oral doses in Japanese patients with type 2 diabetes.

Enrollment: 24 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female non-childbearing potential Japanese T2DM patients, 30-75 years.
• A body mass index (BMI) of 19 to 27 kg/m2.
• Diagnosed Diabetes Mellitus patients treated with diet and exercise or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment.

Exclusion criteria

• Renal dysfunction GFR < 60 mL/min.
• Systolic pressure (SBP) > 160 mmHg or diastolic pressure (DBP) > 95 mmHg
• Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP.
• History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

3 gradually increasing repeated oral doses of AZD1656 given to 3 groups (6 on active substance in each group)

Treatment:

Drug: AZD1656

B

Placebo Comparator group

Description:

Placebo oral suspension given to 3 groups (2 on placebo in each group)

Treatment:

Drug: Placebo