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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01152385
First received: June 10, 2010
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in Haemoglobin A1c (HbA1c) [ Time Frame: from baseline to 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: from baseline to 4 months ] [ Designated as safety issue: No ]
  • Number of Responders in Terms of HbA1C ≤ 7% [ Time Frame: at 4th month ] [ Designated as safety issue: No ]
  • Number of Responders in Terms of HbA1C ≤ 6.5% [ Time Frame: at 4th month ] [ Designated as safety issue: No ]
  • Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: from baseline to 4 months ] [ Designated as safety issue: No ]
  • Percentage Change in High-density Lipoprotein Cholesterol (HDL-C) [ Time Frame: from baseline to 4 months ] [ Designated as safety issue: No ]
  • Percentage Change in Triglycerides [ Time Frame: from baseline to 4 months ] [ Designated as safety issue: No ]
  • Change in High-sensitivity C-reactive Protein (Hs-CRP) [ Time Frame: from baseline to 4 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01152385

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Type 2 diabetes mellitus
Japanese
phase 2
AZD1656
 efficacy
dose regimen
pharmacokinetics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013