Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes Taking Twice-Daily Exenatide or Once-Weekly Exenatide

Type 2 Diabetes Mellitus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803920
• Other study ID #: 03404-06-C
• Status: Completed
• Phase: N/A
• First received: December 4, 2008
• Last updated: December 2, 2015
• Start date: December 2006
• Est. completion date: February 2008

Study information

• Verified date: August 2013
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
United States	International Diabetes Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	Amylin Pharmaceuticals, LLC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize glucose control using periodic CGM in subjects participating in protocol 2993LAR-105 at the International Diabetes Center study site.	Baseline CGM will be performed from Visit 2 to Visit 3 for approximately 14 days followed by a second CGM period from Visit 3 to Visit 6 for approximately 17 days. At Week 28, two weeks after Visit 14 (Week 26), subjects will be instructed to begin CGM and to continue through Visit 20 (Week 30) for Group A subjects or Visit 22 (Week 32) for Group B subjects. At Week 50, two weeks after Visit 28 (Week 48), subjects will be instructed to begin the final CGM period and to continue monitoring until the next study visit at Visit 29 (Week 52)	2 week periods of time - 3 times during study:	No