To Evaluate 24-hr Glucose After OD vs BD AZD1656

Phase 1

Completed

• Conditions: Type II Diabetes
• Interventions: Drug: AZD1656

• Registration Number: NCT00819884
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-08
• Study First Posted: 2009-01-09
• Status Verified: 2009-05
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Last Update Submitted: 2009-05-06
• Last Update Posted: 2009-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD1656	twice daily during 4 days
2	AZD1656	once daily during 4 days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 San Antonio, Texas, United States