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.