Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes Taking Twice-Daily Exenatide or Once-Weekly Exenatide
NCT ID: NCT00803920
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
8 participants
OBSERVATIONAL
2006-12-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Exenatide
No interventions assigned to this group
Exenatide LAR
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* at least 16 years of age
* type 2 diabetes being treated with stable regiment of metformin, SU, TZD, combination of metformin/SU, combination metformin/TZD, combination SU/TZD
* A1c 7.1 - 11
* fasting glucose less than 280 at screening
* BMI 25 - 45
* stable body weight 6 months prior to screening
* not pregnant and willing to practice birth control
* physical exam \& ECG not clinically significant
* lab values judged not to be clinically significant
* able to understand \& sign consent form
Exclusion Criteria
* drug or alcohol abuse
* previous use of exenatide or any GLP-1 analog
* has used any investigational drug in the past 30 days prior to screening
* is currently using: alpha-glucosidase inhibitor, insulin, drugs that affect GI motility, use of systemic corticosteroids, use of medications with addictive potential, prescription or OTC weight-loss medications
* has donated blood within 60 days of screening, or is planning to donate during the study
* has had major surgery or blood transfusion within 2 months of screening
* has had a surgical procedure that may impact gastric emptying
* has any allergies or hypersensitivity to any component of study treatment
* is an immediate family member of personnel affiliated with the study at the investigative site
* is employed by Amylin, Lilly or Alkermes
16 Years
ALL
No
Sponsors
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Amylin Pharmaceuticals, LLC.
INDUSTRY
HealthPartners Institute
OTHER
Responsible Party
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Principal Investigators
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Richard M Bergenstal, MD
Role: PRINCIPAL_INVESTIGATOR
Park Nicollet Institute dba International Diabetes Center
Elinor S Strock, APRN, BC
Role: PRINCIPAL_INVESTIGATOR
Park Nicollet Institute dba International Diabetes Center
Roger S Mazze, PhD
Role: PRINCIPAL_INVESTIGATOR
Park Nicollet Institute dba International Diabetes Center
Locations
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International Diabetes Center
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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03404-06-C
Identifier Type: -
Identifier Source: org_study_id