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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: June 10, 2010
Last updated: July 24, 2012
Last verified: July 2012
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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: AZD1656
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in Haemoglobin A1c (HbA1c) [ Time Frame: from baseline to 4 months ]

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

Enrollment: 224
Study Start Date: May 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: 4 Drug: Placebo
administered twice daily during 4 months


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01152385

Research Site
Osaka, Japan
Research Site
Suita, Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
Study Director: Maria Leonsson-Zachrisson AstraZeneca
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT01152385     History of Changes
Other Study ID Numbers: D1020C00016
Study First Received: June 10, 2010
Results First Received: July 24, 2012
Last Updated: July 24, 2012

Keywords provided by AstraZeneca:
Type 2 diabetes mellitus
phase 2
dose regimen

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on May 25, 2017