Status:
COMPLETED
The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 Diabetes
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
12-21 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to see if giving study drugs before a meal may lower blood sugars after the meal. An improvement in blood sugar control may prevent long-term problems of diabetes.
Detailed Description
A large study in people with type 2 diabetes (T2DM) 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
- Children with Type 2 Diabetes,
- Between the ages of 12-21 years,
- Tanner stage 4-5 for pubertal development,
- Menstruating females must have a negative urine pregnancy test for inclusion,
- Must have T2DM for at least 6 months,
- History of negative anti-glutamic acid decarboxylase (GAD) -65 and anti-islet cell antibodies,
- HbA1c \< 8.5% and on a stable dose of an oral hypoglycemic agent (with or without insulin) over the last 2 months, or well controlled on diet.
Exclusion
- A history of a chronic disease other than diabetes (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, dyslipidemia, cholelithiasis etc),
- BMI\> 40 kg/m2,
- Weight of \< 60 kg,
- Female with menstrual irregularities,
- Allergy to local anesthetics (ELAMAX Cream, Ethyl Chloride),
- Evidence or history of chemical abuse,
- Anemia (age specific normal range for hemoglobin will be used),
- Elevated liver enzymes (defined as more than 3 times the upper limit of the normal range for age),
- Elevated BUN or creatinine (defined as more than 3 times the upper limit of the normal range for age),
- Use of medications that may increase the blood sugars and admission to the hospital for diabetes related problems over the last 6 months.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00950677
Start Date
July 1 2009
End Date
May 1 2011
Last Update
April 24 2017
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030