Clinical trial NCT00803920: Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes Taking Twice-Daily Exenatide or Once-Weekly Exenatide
Official title: CGM Substudy, Addendum 2, of the Following Exenatide LAR Protocol 2993LAR-105: A Randomized, Open-Label, Multicenter, Comparator Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: exenatide twice daily or once weekly
continuous glucose monitoring
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Amylin Pharmaceuticals, LLC.
First posted: 2008-12-08
Enrollment: 8
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to eighteen subjects at the International Diabetes Center study site will be selected for this substudy in accordance with protocol 2993LAR-105

Brief summary: The purpose of this substudy is to obtain CGM data from individuals taking exenatide. The CGM measurements gathered before starting and during treatment with exenatide IR and/or exenatide LAR will help determine the characteristics of glucose control during treatment.


Eligibility criteria: Inclusion Criteria:

* participant in Amylin Protocol 2993LAR-105
* 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:

* clinically significant medical condition as judged by investigator
* 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

Primary outcomes:
measure: Characterize glucose control using periodic CGM in subjects participating in protocol 2993LAR-105 at the International Diabetes Center study site.
timeFrame: 2 week periods of time - 3 times during study:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: Park Nicollet Institute dba International Diabetes Center
name: Richard M Bergenstal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Park Nicollet Institute dba International Diabetes Center
name: Elinor S Strock, APRN, BC
role: PRINCIPAL_INVESTIGATOR
affiliation: Park Nicollet Institute dba International Diabetes Center
name: Roger S Mazze, PhD
role: PRINCIPAL_INVESTIGATOR
References: