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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Byetta (exenatide); Drug: Symlin (pramlintide)

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	concentration and AUC calculations	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glucagon	concentration and AUC calculations	4 hrours
gastric emptying	concentration and AUC calculations	4 hours
pramlintide concentrations	concentration and AUC calculations	4 hours
exenatide concentrations	concentration and AUC calculations	4 hours

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Luisa M Rodriguez, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: July 30, 2009
• First Submitted That Met QC Criteria: July 31, 2009
• First Posted (Estimate): August 3, 2009

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes; gastric emptying; glucagon; exenatide; Symlin; pramlintide; byetta
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Pramlintide; Exenatide
• Other Study ID Numbers: H-22439; K23DK075931 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No