A Study to Evaluate Safety, Tolerability and P-Glucose After Multiple Ascending Oral Doses of AZD1656 in Type 2 Diabetes

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

Official Title
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A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in T2DM Subjects

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: AZD1656
* Drug: AZD1656


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or surgically sterile female of non-childbearing potential (post-menopausal, ie natural or induced menopause with last menstruation >1 year ago and LH and FSH in the post-menopausal range, and/or have undergone hysterectomy and/or bilateral oophorectomy Diagnosed diabetes Mellitus patients treated with diet and exercise alone or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment HbA1c ≤10.5 % at screening (HbA1c value according to international DCCT standard) Exclusion Criteria: Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP History ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results. Positive test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus

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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>3 (alt.4) gradually increasing repeated oral doses of AZD1656 given to 3 (alt.4) groups (6 on active and 2 on placebo in each group) | Drug: AZD1656<br>* Dose titration to 3 (alt 4) increasing dose-steps with oral suspension, 8 days treatment<br>|
| Experimental: 2<br>Oral dose of AZD1656 titrated during 3 days to a tolerable dose (15 on active and 5 on placebo) | Drug: AZD1656<br>* Dose titration of oral suspension to a tolerable dose, 1 month treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (AE, BP, pulse, plasma glucose, 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 |  | Blood samples taken repeatedly during 24 hours on study day sessions | 
| Pharmacodynamic variables |  | 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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Type 2 diabetes