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

NCT00950677 | Completed Phase 4 DMC FDA Drug

• 2 other identifiers: H-22439K23DK075931
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Diabetes; pramlintide; Symlin; exenatide; byetta; glucagon; gastric emptying

Outcome Measures

Primary Outcomes (1)

• Glucose

  concentration and AUC calculations

  4 hours

Secondary Outcomes (4)

• glucagon

  4 hrours

• gastric emptying

  4 hours

• pramlintide concentrations

  4 hours

• exenatide concentrations

  4 hours

Study Arms (2)

exenatide

ACTIVE COMPARATOR

exenatide one dose

Drug: Byetta (exenatide)

pramlintide

ACTIVE COMPARATOR

pramlintide one dose

Drug: Symlin (pramlintide)

Interventions

Byetta (exenatide) DRUG

exenatide 5 mcg subcutaneously

exenatide

Symlin (pramlintide) DRUG

pramlintide 60 mcg subcutaneously

pramlintide

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children with Type 2 Diabetes,
• Between the ages of 12-21 years,
• Tanner stage 4-5 for pubertal development,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Exenatide; pramlintide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• LUISA M RODRIGUEZ, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: August 3, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)