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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: AZD1656
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high<br>AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose) | Drug: AZD1656<br>* Oral tablet administered twice daily during 4 months<br>|
| Experimental: Middle<br>AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose) | Drug: AZD1656<br>* Oral tablet administered twice daily during 4 months<br>|
| Experimental: low<br>AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose) | Drug: AZD1656<br>* Oral tablet administered twice daily during 4 months<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* administered twice daily during 4 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Haemoglobin A1c (HbA1c) |  | from baseline to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fasting Plasma Glucose (FPG) |  | from baseline to 4 months | 
| Number of Responders in Terms of HbA1C ≤ 7% |  | at 4th month | 
| Number of Responders in Terms of HbA1C ≤ 6.5% |  | at 4th month | 
| Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) |  | from baseline to 4 months | 
| Percentage Change in High-density Lipoprotein Cholesterol (HDL-C) |  | from baseline to 4 months | 
| Percentage Change in Triglycerides |  | from baseline to 4 months | 
| Change in High-sensitivity C-reactive Protein (Hs-CRP) |  | from baseline to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, Japanese, phase 2, AZD1656, efficacy, dose regimen, pharmacokinetics