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Completed

NCT Number: NCT01152385

Japan Dose Regimen Study of AZD1656 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Osaka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1656

Drug

Oral tablet administered twice daily during 4 months

Placebo

Drug

administered twice daily during 4 months

Primary outcomes

  1. Change in Haemoglobin A1c (HbA1c)

    Time frame: from baseline to 4 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 29, 2010
Registry last updated
Aug 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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