To Evaluate 24-hr Glucose After OD vs BD AZD1656

Type II Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819884
• Other study ID #: D1020C00017
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2009
• Last updated: May 6, 2009
• Start date: January 2009
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type II Diabetes

Intervention

Drug:
• AZD1656
Oral suspension

Locations

Country	Name	City	State
United States	Research Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Pharmacodynamics (S-Insulin AUC0-24 and C-peptide AUC0-24)		Repeated sampling during the 24 hour period on day -1, 4 and 8	No