A Phase 2 interventional study of Exenatide and Insulin in Type 1 Diabetes, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2019-02-26.
Sponsored by Montefiore Medical Center · Phase 2, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 11 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
***Subjects must be patients of the Texas Children's Hospital Diabetes Care Center***.
All of the following criteria must be met:
Exclusion Criteria:
In each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection
Drug: Exenatide · Drug: Insulin
In each intervention arm the participant receives a different dose of Exenatide along with Insulin as a single subcutaneous injection
Drug: Exenatide · Drug: Insulin
Each subject received a baseline study with insulin alone
Drug: Insulin
In each intervention arm the participant receives a different dose (1.25 or 2.5 mcg) of exenatide.
Also known as: Byetta
Each subject received a baseline study with insulin alone
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
Time frame: 0-120 minutes post-dose
11 subjects were enrolled into the study. Of these, 9 subjects were randomized and only 8 subjects completed this three part study. These subjects were recruited from the diabetes clinics.
| Milestone | Insulin First, Then Exenatide1.25 mcg, Then Exenatide 2.5 mcg | Insulin First, Then Exenatide 2.5 mcg, Then Exenatide 1.25 mcg |
|---|---|---|
| Started | 5 | 4 |
| Completed | 4 | 4 |
| Not completed | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
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
| mmol*L/min | Exenatide 1.25 mcg + Insulin | Exenatide 2.5 mcg + Insulin | Insulin Monotherapy |
|---|---|---|---|
| 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 | 49 ± 156 | 44 ± 281 | 379 ± 259 |
Collected over 0-120 minutes post-dose. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exenatide 1.25 mcg + Insulin | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) |
| Exenatide 2.5 mcg + Insulin | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Insulin Monotherapy | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Event | Exenatide 1.25 mcg + Insulin | Exenatide 2.5 mcg + Insulin | Insulin Monotherapy |
|---|---|---|---|
| HypoglycemiaEndocrine disorders | 1/9 | 0/9 | 0/9 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 17 ± 1 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 4 |
| Male | 5 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 9 |
Plan to share: No
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