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To Evaluate 24-hr Glucose After OD vs BD AZD1656

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00819884
First received: January 8, 2009
Last updated: May 6, 2009
Last verified: May 2009
History of Changes
  Purpose

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 Intervention Phase
Type II Diabetes
 Drug: AZD1656
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: Frequent measurements during the study period ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Repeated sampling at pre-specified timepoints on day 4 and 8 ] [ Designated as safety issue: No ]
  • Pharmacodynamics (S-Insulin AUC0-24 and C-peptide AUC0-24) [ Time Frame: Repeated sampling during the 24 hour period on day -1, 4 and 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
twice daily during 4 days
 Drug: AZD1656
Oral suspension
Experimental: 2
once daily during 4 days
 Drug: AZD1656
Oral suspension

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819884

Locations
United States, Texas
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
  More Information

No publications provided

Responsible Party: Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00819884     History of Changes
Other Study ID Numbers: D1020C00017
Study First Received: January 8, 2009
Last Updated: May 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Type II Diabetes
24 hour glucose profile

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013