To Evaluate 24-hr Glucose After OD vs BD AZD1656

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00819884
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 3.9
• Patients Per Site Per Month: 9.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Type II Diabetes	Drug: AZD1656	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 twice daily during 4 days	Drug: AZD1656; Oral suspension
Experimental: 2 once daily during 4 days	Drug: AZD1656; Oral suspension

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

2. 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]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	San Antonio	Texas	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Klas Malmberg, MD, PhD, Prof.,, AstraZeneca R&D Mölndal
• Principal Investigator: Emanuel P DeNoia, M.D, Healthcare Discoveries LLC Icon Development Solutions

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00819884
• Other Study ID Numbers: D1020C00017
• First Posted: Jan 9, 2009
• Last Update Posted: May 7, 2009
• Last Verified: May 1, 2009

• Keywords provided by , ,: Type II Diabetes; 24 hour glucose profile
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

No Results Posted as of May 7, 2009