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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Baylor College of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00950677
First received: July 30, 2009
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

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 Intervention Phase
Type 2 Diabetes
Drug: Byetta (exenatide)
Drug: Symlin (pramlintide)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Glucose [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • glucagon [ Time Frame: 4 hrours ] [ Designated as safety issue: No ]
  • gastric emptying [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • pramlintide concentrations [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • exenatide concentrations [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: July 2009
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: exenatide
exenatide one dose
Drug: Byetta (exenatide)
exenatide 5 mcg subcutaneously
Other Name: Byetta
Active Comparator: pramlintide
pramlintide one dose
Drug: Symlin (pramlintide)
pramlintide 60 mcg subcutaneously
Other Name: Symlin

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.

  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950677

Contacts
Contact: Kathy Shippy, RN 832-822-3768 kshippy@bcm.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Sub-Investigator: MOREY W HAYMOND, MD         
Sub-Investigator: AGNETA L SUNEHAG, MD         
Sub-Investigator: RUBINA A HEPTULLA, MD         
Sub-Investigator: SIRIPOOM V MCKAY, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: LUISA M RODRIGUEZ, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Luisa M Rodriguez, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00950677     History of Changes
Other Study ID Numbers: H-22439
Study First Received: July 30, 2009
Last Updated: December 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Diabetes
pramlintide
Symlin
exenatide
byetta
glucagon
gastric emptying

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Pramlintide
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014