Role of Exenatide in Type 1 Diabetes

NCT00456300 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: H-16488
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal. This study may help in developing new treatments to help control high blood sugars after meals. This may help improve overall blood sugar control and prevent the long-term effects of diabetes.

Conditions

Type 1 Diabetes

Keywords

Hypoglycemia; Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Mean Plasma Glucose Area Under the Curve (AUC) for Blood Glucose Concentration in the Exenatide 1.25 mcg or Exenatide 2.5 mcg Treated Groups Along With Insulin, Compared to Insulin Alone

  Post-prandial blood glucose concentration in terms of mean AUC (0-120 min) was determined in subjects treated with either Exenatide 1.25 mcg or Exenatide 2.5 along with insulin, compared to insulin alone, given as a single subcutaneous injection

  0-120 minutes post-dose

Study Arms (3)

Exenatide 1.25 mcg + Insulin

EXPERIMENTAL

In each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection

Drug: Exenatide; Drug: Insulin

Exenatide 2.5 mcg + Insulin

EXPERIMENTAL

In each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection

Drug: Exenatide; Drug: Insulin

Insulin

ACTIVE COMPARATOR

Each subject received a baseline study with insulin alone

Drug: Insulin

Interventions

Exenatide DRUG

In each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide.

Also known as: Byetta

Exenatide 1.25 mcg + Insulin; Exenatide 2.5 mcg + Insulin

Insulin DRUG

Each subject received a baseline study with insulin alone

Exenatide 1.25 mcg + Insulin; Exenatide 2.5 mcg + Insulin; Insulin

Eligibility Criteria

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

You may qualify if:

• \*\*\*Subjects must be patients of the Texas Children's Hospital Diabetes Care Center\*\*\*.
• All of the following criteria must be met:
• Between 12-21 years of age at the time of enrollment.
• Have been diagnosed with Type 1 diabetes for at least 1 year and in good control (HbA1C less than 8.5%).
• Subjects must be otherwise healthy except for the Type 1 Diabetes and treated hypothyroidism.
• Menstruating women must have a negative pregnancy test.
• Hemoglobin equal to or greater than 12 g/dL before each study.
• Weight greater than 44 kg.
• Tanner stage greater than 3

You may not qualify if:

• Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc or on treatment that might directly or indirectly affect glucose homeostasis, except for diabetes and hypothyroidism; stable on medications.
• Lack of a supportive family environment as detected by the clinicians and/or social workers.
• Positive pregnancy test in menstruating young women.
• BMI greater than 90th percentile for age or less than 10th percentile for age.
• Lactating and nursing mothers.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Texas Children's Hospital/ Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Raman VS, Mason KJ, Rodriguez LM, Hassan K, Yu X, Bomgaars L, Heptulla RA. The role of adjunctive exenatide therapy in pediatric type 1 diabetes. Diabetes Care. 2010 Jun;33(6):1294-6. doi: 10.2337/dc09-1959. Epub 2010 Mar 23.

  PMID: 20332358 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Hyperglycemia

Interventions

Exenatide; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Rubina Heptulla
• Organization: Montefiore Medical College

rubhep@gmail.com

832824000

Study Officials

• Rubina Heptulla, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2007
• First Posted: April 4, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: February 26, 2019
• Results First Posted: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)