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

AstraZeneca1 site in 1 country36 target enrollmentJanuary 2009

ConditionsType II Diabetes

InterventionsAZD1656

DrugsAZD1656

Overview

Phase: Phase 1
Intervention: AZD1656
Conditions: Type II Diabetes
Sponsor: AstraZeneca
Enrollment: 36
Locations: 1
Primary Endpoint: 24-hr glucose (Calculated plasma glucose AUC0-24, change in fasting plasma glucose)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

May 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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

Arms & Interventions

1

twice daily during 4 days

Intervention: AZD1656

2

once daily during 4 days

Intervention: AZD1656

Outcomes

Primary Outcomes

24-hr glucose (Calculated plasma glucose AUC0-24, change in fasting plasma glucose)

Time Frame: Repeated sampling during the 24 hour period on day -1, 4 and 8

Secondary Outcomes

Pharmacodynamics (S-Insulin AUC0-24 and C-peptide AUC0-24)(Repeated sampling during the 24 hour period on day -1, 4 and 8)
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)