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To Evaluate 24-hr Glucose After OD vs BD AZD1656

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ClinicalTrials.gov Identifier: NCT00819884
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : May 7, 2009
Sponsor:
Information provided by:
AstraZeneca

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 Type : Interventional  (Clinical Trial)
Estimated 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 : January 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 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) [ Time Frame: 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 [ Time Frame: Repeated sampling at pre-specified timepoints on day 4 and 8 ]
  3. 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 ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: May 7, 2009
Last Verified: May 2009

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

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