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

Completed · Phase 4

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT00950677

Run by

Baylor College of Medicine

People needed

16

Starts

2009-07-01

Expected to finish

2011-05-01

Last updated by the study team

2017-04-24

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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