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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014