Role of Exenatide in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00456300
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : December 1, 2010
National Institutes of Health (NIH)
Information provided by:
Baylor College of Medicine

Brief Summary:
The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal. This study may help in developing new treatments to help control high blood sugars after meals. This may help improve overall blood sugar control and prevent the long-term problems of diabetes.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Exenatide Phase 4

Detailed Description:

A large study in people with type 1 diabetes (T1DM) showed that lowering blood sugars stopped or delayed the occurrence of health problems. As a result of the study, treatment should try to control blood sugar as near to normal as safely possible.

In people without diabetes, the "after meal" blood sugar level is very carefully controlled. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. We now know that a substance made by the body called GLP-1 also helps with this careful balance. GLP-1 works in four ways. First, it helps to stimulate the cells in the pancreas to produce more insulin. Secondly, it helps to "dampen" the glucagon response (glucagon is released after a meal and causes the blood sugar to rise). Thirdly, GLP-1 delays the digestion of food in the stomach. Lastly, it seems to "dampen" the appetite, which causes a person to eat less.

Exenatide is a medication that works very similar to GLP-1. Exenatide is FDA approved for use in adults.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Role of Exenatide in Type 1 Mellitus
Study Start Date : March 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Exenatide
U.S. FDA Resources

Intervention Details:
    Drug: Exenatide
    3 doses of exenatide will be tested in same group of patients
    Other Name: Exenatide or Byetta

Primary Outcome Measures :
  1. Area under the curve for glucose [ Time Frame: 5 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

***Subjects must be patients of the Texas Children's Hospital Diabetes Care Center***.

All of the following criteria must be met:

  1. Between 12-21 years of age at the time of enrollment.
  2. Have been diagnosed with Type 1 diabetes for at least 1 year and in good control (HbA1C less than 8.5%).
  3. Subjects must be otherwise healthy except for their TIDM and treated hypothyroidism.
  4. Menstruating women must have a negative pregnancy test.
  5. Hemoglobin equal to or greater than 12 g/dL before each study.
  6. Weight greater than 44 kg.
  7. Tanner stage greater than 3

Exclusion Criteria:

  1. Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc or on treatment that might directly or indirectly affect glucose homeostasis, except for diabetes and hypothyroidism; stable on medications.
  2. Lack of a supportive family environment as detected by the clinicians and/or social workers.
  3. Positive pregnancy test in menstruating young women.
  4. BMI greater than 90th percentile for age or less than 10th percentile for age.
  5. Lactating and nursing mothers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00456300

United States, Texas
Texas Children's Hospital/ Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
National Institutes of Health (NIH)
Principal Investigator: Rubina Heptulla, MD Baylor College of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rubina Heptulla, MD, Baylor College of Medicine Identifier: NCT00456300     History of Changes
Other Study ID Numbers: H-16488
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: November 2010

Keywords provided by Baylor College of Medicine:
Type 1 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists