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Role of Exenatide in Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00456300
First received: April 3, 2007
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Type 1 Diabetes
Drug: Exenatide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Role of Exenatide in Type 1 Mellitus

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Area under the curve for glucose [ Time Frame: 5 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 17
Study Start Date: March 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Exenatide
    3 doses of exenatide will be tested in same group of patients
    Other Name: Exenatide or Byetta
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.

  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456300

Locations
United States, Texas
Texas Children's Hospital/ Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Rubina Heptulla, MD Baylor College of Medicine
  More Information

No publications provided by Baylor College of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rubina Heptulla, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00456300     History of Changes
Other Study ID Numbers: H-16488
Study First Received: April 3, 2007
Last Updated: November 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Type 1 Diabetes
Hyperglycemia
Hypoglycemia

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

ClinicalTrials.gov processed this record on November 27, 2014