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

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)

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • International Diabetes Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Exenatide
Exenatide LAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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:

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: Amylin Pharmaceuticals, LLC.
• Investigators: Principal Investigator: Richard M Bergenstal, MD, Park Nicollet Institute dba International Diabetes Center; Principal Investigator: Elinor S Strock, APRN, BC, Park Nicollet Institute dba International Diabetes Center; Principal Investigator: Roger S Mazze, PhD, Park Nicollet Institute dba International Diabetes Center

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: December 4, 2008
• First Submitted That Met QC Criteria: December 5, 2008
• First Posted (Estimate): December 8, 2008

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: continuous glucose monitoring; exenatide twice daily or once weekly
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 03404-06-C