To Study Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1656 in Japanese Type 2 Diabetes Mellitus (T2DM) Patients

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and tolerability of AZD1656 after multiple repeated oral doses in Japanese patients with type 2 diabetes.

Official Title
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A Randomized, Single-blind, Placebo-Controlled, Multi-centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Japanese T2DM Patients

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: AZD1656
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female non-childbearing potential Japanese T2DM patients, 30-75 years. A body mass index (BMI) of 19 to 27 kg/m2. Diagnosed Diabetes Mellitus patients treated with diet and exercise or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment. Exclusion Criteria: Renal dysfunction GFR < 60 mL/min. Systolic pressure (SBP) > 160 mmHg or diastolic pressure (DBP) > 95 mmHg Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP. History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>3 gradually increasing repeated oral doses of AZD1656 given to 3 groups (6 on active substance in each group) | Drug: AZD1656<br>* Three increasing dose-steps with oral suspension, 8 days treatment<br>|
| Placebo Comparator: B<br>Placebo oral suspension given to 3 groups (2 on placebo in each group) | Drug: Placebo<br>* Placebo oral suspension, 8 days treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety by assessment of adverse events, BP, pulse rate, plasma glucose, safety laboratory variables and ECG |  | Blood samples taken repeatedly during 24 hours on study day sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables (AUC, Cmax, tmax, t½, CL/F, Ae and CLR). |  | Blood samples taken repeatedly during 24 hours on study day sessions | 
| Pharmacodynamic variables (P-Glucose, S-Insulin and S-C-peptide). |  | Blood samples taken repeatedly during 24 hours on study day sessions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AZD1656, Safety, Pharmacokinetics, Pharmacodynamic, Multiple ascending doses, Japanese, T2DM