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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01152385
Recruitment Status : Completed
First Posted : June 29, 2010
Results First Posted : August 27, 2012
Last Update Posted : August 27, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: AZD1656 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : May 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01152385


Locations
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Japan
Research Site
Osaka, Japan
Research Site
Suita, Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Maria Leonsson-Zachrisson AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01152385    
Other Study ID Numbers: D1020C00016
First Posted: June 29, 2010    Key Record Dates
Results First Posted: August 27, 2012
Last Update Posted: August 27, 2012
Last Verified: July 2012
Keywords provided by AstraZeneca:
Type 2 diabetes mellitus
Japanese
phase 2
AZD1656
 efficacy
dose regimen
pharmacokinetics
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases