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The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 Diabetes (T2DM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00950677
Recruitment Status : Completed
First Posted : August 3, 2009
Last Update Posted : April 24, 2017
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Luisa M. Rodriguez, Baylor College of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Byetta (exenatide) Drug: Symlin (pramlintide) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of the Glucagon Suppressors Pramlintide and Exenatide on Postprandial Glucose Metabolism in Children With Type 2 Diabetes Mellitus
Study Start Date : July 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: exenatide
exenatide one dose
Drug: Byetta (exenatide)
exenatide 5 mcg subcutaneously

Active Comparator: pramlintide
pramlintide one dose
Drug: Symlin (pramlintide)
pramlintide 60 mcg subcutaneously

Primary Outcome Measures :
  1. Glucose [ Time Frame: 4 hours ]
    concentration and AUC calculations

Secondary Outcome Measures :
  1. glucagon [ Time Frame: 4 hrours ]
    concentration and AUC calculations

  2. gastric emptying [ Time Frame: 4 hours ]
    concentration and AUC calculations

  3. pramlintide concentrations [ Time Frame: 4 hours ]
    concentration and AUC calculations

  4. exenatide concentrations [ Time Frame: 4 hours ]
    concentration and AUC calculations

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00950677

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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: LUISA M RODRIGUEZ, MD Baylor College of Medicine
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Responsible Party: Luisa M. Rodriguez, Principal Investigator, Baylor College of Medicine Identifier: NCT00950677    
Other Study ID Numbers: H-22439
K23DK075931 ( U.S. NIH Grant/Contract )
First Posted: August 3, 2009    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luisa M. Rodriguez, Baylor College of Medicine:
gastric emptying
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Hormones, Hormone Substitutes, and Hormone Antagonists