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

July 24, 2012 updated by: AstraZeneca

A 4-month Treatment, Randomized, Double-blind, Placebo-Controlled, Multi-centre, Parallel-Group Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of Different Dosing Regimens of AZD1656 as Monotherapy in Japanese Type 2 Diabetes Mellitus Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan
        • Research Site
      • Suita, Japan
        • Research Site
      • Tokyo, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 4
Drug: Placebo
administered twice daily during 4 months
Experimental: high
AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
Drug: AZD1656
Oral tablet administered twice daily during 4 months
Experimental: Middle
AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
Drug: AZD1656
Oral tablet administered twice daily during 4 months
Experimental: low
AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
Drug: AZD1656
Oral tablet administered twice daily during 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Haemoglobin A1c (HbA1c)
Time Frame: from baseline to 4 months
from baseline to 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Fasting Plasma Glucose (FPG)
Time Frame: from baseline to 4 months
from baseline to 4 months
Number of Responders in Terms of HbA1C ≤ 7%
Time Frame: at 4th month
at 4th month
Number of Responders in Terms of HbA1C ≤ 6.5%
Time Frame: at 4th month
at 4th month
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C)
Time Frame: from baseline to 4 months
from baseline to 4 months
Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)
Time Frame: from baseline to 4 months
from baseline to 4 months
Percentage Change in Triglycerides
Time Frame: from baseline to 4 months
from baseline to 4 months
Change in High-sensitivity C-reactive Protein (Hs-CRP)
Time Frame: from baseline to 4 months
from baseline to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Maria Leonsson-Zachrisson, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 26, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Estimate)

August 27, 2012

Last Update Submitted That Met QC Criteria

July 24, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1020C00016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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