Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Role of Exenatide in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00456300
Recruitment Status : Completed
First Posted : April 4, 2007
Results First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Rubina Heptulla, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Exenatide Drug: Insulin Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Role of Exenatide in Type 1 Diabetes Mellitus
Actual Study Start Date : March 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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
Drug: Exenatide
In each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide.
Other Name: Byetta

Drug: Insulin
Each subject received a baseline study with insulin alone

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
Drug: Exenatide
In each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide.
Other Name: Byetta

Drug: Insulin
Each subject received a baseline study with insulin alone

Active Comparator: Insulin
Each subject received a baseline study with insulin alone
Drug: Insulin
Each subject received a baseline study with insulin alone




Primary Outcome Measures :
  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 [ Time Frame: 0-120 minutes post-dose ]
    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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

***Subjects must be patients of the Texas Children's Hospital Diabetes Care Center***.

All of the following criteria must be met:

  1. Between 12-21 years of age at the time of enrollment.
  2. Have been diagnosed with Type 1 diabetes for at least 1 year and in good control (HbA1C less than 8.5%).
  3. Subjects must be otherwise healthy except for the Type 1 Diabetes and treated hypothyroidism.
  4. Menstruating women must have a negative pregnancy test.
  5. Hemoglobin equal to or greater than 12 g/dL before each study.
  6. Weight greater than 44 kg.
  7. Tanner stage greater than 3

Exclusion Criteria:

  1. 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.
  2. Lack of a supportive family environment as detected by the clinicians and/or social workers.
  3. Positive pregnancy test in menstruating young women.
  4. BMI greater than 90th percentile for age or less than 10th percentile for age.
  5. Lactating and nursing mothers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456300


Locations
Layout table for location information
United States, Texas
Texas Children's Hospital/ Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Montefiore Medical Center
National Institutes of Health (NIH)
Investigators
Layout table for investigator information
Principal Investigator: Rubina Heptulla, MD Montefiore Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Rubina Heptulla, Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00456300     History of Changes
Other Study ID Numbers: H-16488
First Posted: April 4, 2007    Key Record Dates
Results First Posted: February 26, 2019
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rubina Heptulla, Montefiore Medical Center:
Hypoglycemia
Hyperglycemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists