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
1 other identifier
interventional
36
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 8, 2009
CompletedFirst Posted
Study publicly available on registry
January 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedMay 7, 2009
May 1, 2009
4 months
January 8, 2009
May 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (3)
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
Study Arms (2)
1
EXPERIMENTALtwice daily during 4 days
2
EXPERIMENTALonce daily during 4 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
San Antonio, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 8, 2009
First Posted
January 9, 2009
Study Start
January 1, 2009
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
May 7, 2009
Record last verified: 2009-05