Status:
COMPLETED
Role of Exenatide in Type 1 Diabetes
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
12-21 years
Phase:
PHASE2
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 s...
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 bl...
Eligibility Criteria
Inclusion
- \*\*\*Subjects must be patients of the Texas Children's Hospital Diabetes Care Center\*\*\*.
- All of the following criteria must be met:
- Between 12-21 years of age at the time of enrollment.
- Have been diagnosed with Type 1 diabetes for at least 1 year and in good control (HbA1C less than 8.5%).
- Subjects must be otherwise healthy except for the Type 1 Diabetes and treated hypothyroidism.
- Menstruating women must have a negative pregnancy test.
- Hemoglobin equal to or greater than 12 g/dL before each study.
- Weight greater than 44 kg.
- Tanner stage greater than 3
Exclusion
- 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.
- Lack of a supportive family environment as detected by the clinicians and/or social workers.
- Positive pregnancy test in menstruating young women.
- BMI greater than 90th percentile for age or less than 10th percentile for age.
- Lactating and nursing mothers.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00456300
Start Date
March 1 2007
End Date
March 1 2009
Last Update
February 26 2019
Active Locations (1)
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1
Texas Children's Hospital/ Baylor College of Medicine
Houston, Texas, United States, 77030