Overview

The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 Diabetes

Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Treatments:
Exenatide
Glucagon
Islet Amyloid Polypeptide
Pramlintide
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.