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

Type 2 Diabetes Clinical Trial

— T2DM  

Official title:

The Effect of the Glucagon Suppressors Pramlintide and Exenatide on Postprandial Glucose Metabolism in Children With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950677
• Other study ID #: H-22439
• Secondary ID: K23DK075931
• Status: Completed
• Phase: Phase 4
• First received: July 30, 2009
• Last updated: April 21, 2017
• Start date: July 2009
• Est. completion date: May 2011

Study information

• Verified date: April 2017
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 blood sugars as near to normal as safely possible.

In people without diabetes, the "after meal" blood sugar level is very carefully controlled by several hormones. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. Also, we now know of 2 new substances made by the body called amylin and GLP-1 that also help with this careful balance. Amylin is made in the pancreas. GLP-1 is made in the gut. We know that both amylin and GLP-1 are abnormal in people with diabetes.

There are two medicines that may help to control after meal blood sugars from going too high. The medicines are called Symlin (pramlintide) and Byetta (exenatide). Symlin works like amylin. Byetta works like GLP-1. Both medications are very similar in the ways that they work to control blood sugars.

Both medicines help to keep glucagon lower after a meal. They both also help the stomach to digest food more slowly so the blood sugar does not go up too fast after eating. They also help to control how much hunger a person may have before meals. This may help a person to eat less and possibly lose weight. Byetta also seems to help islet cells (cells that make insulin) make more insulin.

Byetta and Symlin are FDA approved for use in adults with T2DM. We want to study these drugs in children with T2DM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Byetta (exenatide)
exenatide 5 mcg subcutaneously
• Symlin (pramlintide)
pramlintide 60 mcg subcutaneously

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose	concentration and AUC calculations	4 hours
Secondary	glucagon	concentration and AUC calculations	4 hrours
Secondary	gastric emptying	concentration and AUC calculations	4 hours
Secondary	pramlintide concentrations	concentration and AUC calculations	4 hours
Secondary	exenatide concentrations	concentration and AUC calculations	4 hours