Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide - Full Text View

Sponsors and Collaborators:	Park Nicollet Institute Eli Lilly and Company
Information provided by:	Park Nicollet Institute
ClinicalTrials.gov Identifier:	NCT00569907

Purpose

Approximately 30 adults will participate in this study at the International Diabetes Center (IDC). The IDC is the only site conducting this study.

Length of participation can range from two to three months which will include four to seven clinic visits.

The purpose of this study is to use a Continuous Glucose Monitoring (CGM) system to determine the characteristics of glucose control and patterns of food intake before exenatide is started, during the start and adjustment of exenatide and during exenatide treatment.

The long-term purpose of this study is to determine to what extent continuous glucose monitoring improves or alters clinical decision making for patients treated with exenatide. And, the study will also compare CGM to conventional self-monitored blood glucose methods.

The study will also compare subjects' changes, if any, in nutrient intake such as energy, protein, fat and carbohydrate during the course of the study through interpretation/analysis of self-reported food intake.

Condition
Diabetes Mellitus Type 2

MedlinePlus related topics: Diabetes

Drug Information available for: Exenatide Dextrose

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Crossover, Prospective
Official Title:	Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide

Further study details as provided by Park Nicollet Institute:

Estimated Enrollment:	30
Study Start Date:	January 2007
Estimated Study Completion Date:	May 2010

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Community sample.

Criteria

Inclusion Criteria:

Male or female (if of child-bearing age must practice appropriate birth control such as tubal ligation, oral contraceptives, abstinence or vasectomized partner during the duration of the study)
Previously diagnosed with type 2 diabetes
Age 21 and older
Treated with metformin, a sulfonylurea, a thiazolidinedione, a combination or metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione (approved FDA indications)
HbA1c 7.1-11%, unless subject has been using exenatide prior to study; in that case, there is no restriction on HbA1c level.
Willing to give informed consent
Motivated and capable of following the protocol and instructions provided by the healthcare professional
Available for the study on the scheduled visit days
Access to telephone communications

Exclusion Criteria:

Under 21 years of age
Pregnancy
Creatinine clearance <30 ml/min (using MDRD formula)
Known gastrointestinal disease
Without diabetes or known type 1 diabetes
Unable to follow the study protocol
Unable to read and write in English
Allergy to adhesives
Any concomitant medical condition that would likely affect the evaluation of CGM device performance as determined by the investigator such as dermatological conditions or myxedema.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569907

Contacts

Contact: Nathan Tessum	952-993-3267	nathan.tessum@parknicollet.com
Contact: Kimberly Gunyou	952-993-3640	kimberly.gunyou@parknicollet.com

Locations

United States, Minnesota
International Diabetes Center - Park Nicollet Health Services	Recruiting
Minneapolis, Minnesota, United States, 55416
Principal Investigator: Roger Mazze, PhD
Principal Investigator: Robert M. Cuddihy, MD
Principal Investigator: Ellie Strock, ANP

Sponsors and Collaborators

Park Nicollet Institute

Eli Lilly and Company

Investigators

Principal Investigator:	Roger Mazze, PhD	International Diabetes Center - Park Nicollet Institute
Principal Investigator:	Robert M. Cuddihy, MD	International Diabetes Center - Park Nicollet Institute
Principal Investigator:	Ellie Strock, ANP	International Diabetes Center - Park Nicollet Institute

More Information

Publications:

Mazze RS, Lucido D, Langer O, Hartmann K, Rodbard D. Ambulatory glucose profile: representation of verified self-monitored blood glucose data. Diabetes Care. 1987 Jan-Feb;10(1):111-7.

Buse JB, Henry RR, Han J, Kim DD, Fineman MS, Baron AD; Exenatide-113 Clinical Study Group. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care. 2004 Nov;27(11):2628-35.

DeFronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005 May;28(5):1092-100.

Garg S, Zisser H, Schwartz S, Bailey T, Kaplan R, Ellis S, Jovanovic L. Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. Diabetes Care. 2006 Jan;29(1):44-50.

Responsible Party:	Park Nicollet Institute dba International Diabetes Center ( Roger S. Mazze, PhD - Chief Academic Officer )
Study ID Numbers:	03520-06-C
Study First Received:	December 6, 2007
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00569907
Health Authority:	United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:

type 2 diabetes
continuous glucose monitoring
exenatide
exenatide use

Study placed in the following topic categories:

Metabolic Diseases
Exenatide
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009