Clinical trial NCT01152385: Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Japanese
phase 2
AZD1656
efficacy
dose regimen
pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 224
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Haemoglobin A1c (HbA1c)
timeFrame: from baseline to 4 months
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: from baseline to 4 months
measure: Number of Responders in Terms of HbA1C ≤ 7%
timeFrame: at 4th month
measure: Number of Responders in Terms of HbA1C ≤ 6.5%
timeFrame: at 4th month
measure: Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: from baseline to 4 months
measure: Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: from baseline to 4 months
measure: Percentage Change in Triglycerides
timeFrame: from baseline to 4 months
measure: Change in High-sensitivity C-reactive Protein (Hs-CRP)
timeFrame: from baseline to 4 months
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Research Site
city: Suita
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Maria Leonsson-Zachrisson
role: STUDY_DIRECTOR
References:
citation: Kiyosue A, Hayashi N, Komori H, Leonsson-Zachrisson M, Johnsson E. Dose-ranging study with the glucokinase activator AZD1656 as monotherapy in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2013 Oct;15(10):923-30. doi: 10.1111/dom.12100. Epub 2013 Apr 22.