- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00456300
Role of Exenatide in Type 1 Diabetes
The Role of Exenatide in Type 1 Diabetes Mellitus
Study Overview
Detailed Description
A large study in people with type 1 diabetes (T1DM) 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. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. It is now known that a substance made by the body called GLP-1 also helps with this careful balance. Glucagon like peptide-1 works in four ways. First, it helps to stimulate the cells in the pancreas to produce more insulin. Secondly, it helps to "dampen" the glucagon response (glucagon is released after a meal and causes the blood sugar to rise). Thirdly, Glucagon like peptide-1 delays the digestion of food in the stomach. Lastly, it seems to "dampen" the appetite, which causes a person to eat less.
Exenatide is a medication that works very similar to Glucagon like peptide-1. Exenatide is FDA approved for use in adults.
Study Design: Followed by a baseline study with insulin alone, subjects were randomized to two different doses of exenatide (1.25 and 2.5 µ,g), administered in a double-blinded randomized controlled manner, along with insulin as a single subcutaneous injection. Studies were at least 3 weeks apart.
Baseline: At 0800 h, the pre-breakfast insulin bolus was administered based on patient's usual insulin-to-carbohydrate ratio. Post-bolus, subjects drank 12 ounces of a standard liquid meal (Boost High Protein Drink, 360 calories, 50 g carbohydrates, and 12 g fat), enriched with 1 g of [13C] glucose within 10 min. Breath samples for 13CO2 analysis were collected in duplicates at 17 time points until 1300 h. Usual insulin basal rates or glargine were maintained during study.
On the days subjects received the study drug of 1.25 µ,g (~0.02 µ,g/kg) or 2.5 µ,g (~0.04 µ,g/kg) exenatide along with insulin, the prandial insulin was reduced by 20%.
Measurements: Plasma glucose was measured using a bedside YSI glucose analyzer (2300 Stat Plus; Yellow Springs Instruments, Yellow Springs, OH) throughout the study at regularly timed intervals. Delta plasma glucose area under the curve (AUC0 -120) was measured for the exenatide treated groups vs. insulin monotherapy.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital/ Baylor College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
***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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Exenatide 1.25 mcg + Insulin
In each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection
|
In each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide.
Other Names:
Each subject received a baseline study with insulin alone
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Experimental: Exenatide 2.5 mcg + Insulin
In each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection
|
In each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide.
Other Names:
Each subject received a baseline study with insulin alone
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Active Comparator: Insulin
Each subject received a baseline study with insulin alone
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Each subject received a baseline study with insulin alone
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 0-120 minutes post-dose
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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
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0-120 minutes post-dose
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rubina Heptulla, MD, Montefiore Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Obesity Agents
- Incretins
- Exenatide
Other Study ID Numbers
- H-16488
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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