To Evaluate 24-hr Glucose After OD vs BD AZD1656

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00819884

Enrollment

Registered

2009-01-09

Start date

2009-01-31

Completion date

2009-05-31

Last updated

2009-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II Diabetes

Keywords

Type II Diabetes, 24 hour glucose profile

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

Interventions

DRUGAZD1656

Oral suspension

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026