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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00916604

Type 2 Diabetes

COMPLETED PHASE1

A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Japanese Participants and Participants With Type 2 Diabetes Mellitus

NCT06703658

Healthy Participants Type 2 Diabetes

COMPLETED PHASE1

Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes

NCT00856908

Type II Diabetes

COMPLETED PHASE2

Dose Response Study in Japanese Patients

NCT00261417

Type 2 Diabetes

TERMINATED PHASE2

A Study to Evaluate Safety, Tolerability and P-Glucose After Multiple Ascending Oral Doses of AZD1656 in Type 2 Diabetes

NCT00747175

Type 2 Diabetes

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

high

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

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Oral tablet administered twice daily during 4 months

Middle

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

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Oral tablet administered twice daily during 4 months

low

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

Group Type EXPERIMENTAL

AZD1656

Intervention Type DRUG

Oral tablet administered twice daily during 4 months

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

administered twice daily during 4 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD1656

Oral tablet administered twice daily during 4 months

Intervention Type DRUG

Placebo

administered twice daily during 4 months

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No