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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Characterize glucose control using periodic CGM in subjects participating in protocol 2993LAR-105 at the International Diabetes Center study site.

Time frame: 2 week periods of time - 3 times during study:

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)

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

Amylin Pharmaceuticals, LLC.

Registry information

Official study 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)

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Dec 8, 2008
Registry last updated: Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed