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NCT00950677·Phase 4·INTERVENTIONAL

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

PramlintideType 2 diabetesCompleted

Status

Completed

Phase

Phase 4

Enrollment

16

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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 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.

Interventions

Treatment arms and agents.

DRUG

Byetta (exenatide)

exenatide 5 mcg subcutaneously

DRUG

Symlin (pramlintide)

pramlintide 60 mcg subcutaneously

Timeline

From registration to results.

  1. First posted

    Aug 3, 2009

  2. Study start

    Jul 2009

  3. Primary completion

    May 2011

  4. Study completion

    May 2011

  5. Results posted

    Not reported

  6. Registry updated

    Apr 24, 2017

Outcomes

What the study measures.

Primary outcomes

Glucose

Time frame · 4 hours

concentration and AUC calculations

Secondary outcomes

glucagon

Time frame · 4 hrours

concentration and AUC calculations

gastric emptying

Time frame · 4 hours

concentration and AUC calculations

pramlintide concentrations

Time frame · 4 hours

concentration and AUC calculations

exenatide concentrations

Time frame · 4 hours

concentration and AUC calculations

Eligibility

Who can take part.

Minimum age
12 Years
Maximum age
21 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Baylor College of Medicine

Houston, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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