To Evaluate 24-hr Glucose After OD vs BD AZD1656

Study Overview
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Brief Summary
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The purpose of this study is to compare the 24-hour glucose profiles in diabetic patients treated with metformin following once daily and twice daily oral dosing

Official Title
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A Randomised, Two Way Cross-Over, Single-Blind, Phase I Study to Evaluate 24-hr Glucose Profiles in Patients With T2DM When Dosed OD and BD on Top of Metformin for Four Days With AZD1656

Conditions
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Type II Diabetes

Intervention / Treatment
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* Drug: AZD1656


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type II diabetes patients, female with non child-bearing potential Type 2 Diabetes Mellitus (T2DM) diagnosis confirmed by C-peptide >0.3nmol/L and no Glutamic acid decarboxylase (GAD) antibodies at enrolment (screening) Treatment with metformin as single therapy for T2DM for at least 30 days prior to enrolment and the metformin dose must have been unchanged during this period Exclusion Criteria: History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease Any clinically significant abnormality identified on physical examination, laboratory test or ECG, which in the judgement of investigator would compromise the subject's safety or successful participation in the clinical study

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>twice daily during 4 days | Drug: AZD1656<br>* Oral suspension<br>|
| Experimental: 2<br>once daily during 4 days | Drug: AZD1656<br>* Oral suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hr glucose (Calculated plasma glucose AUC0-24, change in fasting plasma glucose) |  | Repeated sampling during the 24 hour period on day -1, 4 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability (Adverse events (AEs) during the study, blood pressure (BP), pulse rate, safety laboratory variables (incl. glucose) and investigator's interpretation of electrocardiogram (ECG) |  | Frequent measurements during the study period | 
| Pharmacokinetic variables (Area under the plasma conc vs. time curve (AUC0-24), maximum plasma conc (Cmax), time to reach maximum plasma conc(tmax), terminal elimination half-life and apparent oral clearance |  | Repeated sampling at pre-specified timepoints on day 4 and 8 | 
| Pharmacodynamics (S-Insulin AUC0-24 and C-peptide AUC0-24) |  | Repeated sampling during the 24 hour period on day -1, 4 and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type II Diabetes, 24 hour glucose profile