Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: AZD1656; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01152385

D1020C00016

Details and patient eligibility

About

The purpose of this study is to compare the effect on glucose control of 3 different AZD1656 dosing regimens with placebo in Japanese type 2 diabetes mellitus (T2DM) patients, as evaluated by the change in HbA1c from baseline to the end of treatment at 4 months.

Enrollment: 224 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women of non-childbearing potential.
• Provision of informed consent prior to any study specific procedures
• Naïve T2DM patients with HbA1c ≥ 7.5% but ≤ 10% or T2DM Patients treated with one or two oral anti-hyperglycaemic agent(s) with HbA1c ≥ 7.5% but ≤ 9.5% at enrolment visit (Visit1)

Exclusion criteria

• Clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, 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.
• Participation in another clinical trial and/or intake of another investigational drug within the last 30 days prior to enrolment visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

224 participants in 4 patient groups, including a placebo group

high

Experimental group

Description:

AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)

Treatment:

Drug: AZD1656

Middle

Experimental group

Description:

AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)

Treatment:

Drug: AZD1656

low

Experimental group

Description:

AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)

Treatment:

Drug: AZD1656

4

Placebo Comparator group

Treatment:

Drug: Placebo