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Role of Exenatide in Type 1 Diabetes

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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

Tracking Information
First Submitted Date  ICMJE April 3, 2007
First Posted Date  ICMJE April 4, 2007
Results First Submitted Date  ICMJE March 13, 2018
Results First Posted Date  ICMJE February 26, 2019
Last Update Posted Date February 26, 2019
Actual Study Start Date  ICMJE March 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2007)
Area under the curve for glucose
Change History Complete list of historical versions of study NCT00456300 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Exenatide in Type 1 Diabetes
Official Title  ICMJE The Role of Exenatide in Type 1 Diabetes Mellitus
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Exenatide
    • Drug: Insulin
  • 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
    Interventions:
    • Drug: Exenatide
    • Drug: Insulin
  • Active Comparator: Insulin
    Each subject received a baseline study with insulin alone
    Intervention: Drug: Insulin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2019)
11
Original Enrollment  ICMJE
 (submitted: April 3, 2007)
17
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00456300
Other Study ID Numbers  ICMJE H-16488
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rubina Heptulla, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Rubina Heptulla, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP