Primary outcome
What NCT00456300 measured first
| Exenatide 1.25 mcg + Insulinn=8 | Exenatide 2.5 mcg + Insulinn=8 | Insulin Monotherapyn=8 |
|---|---|---|
| 49(156) | 44(281) | 379(259) |
Phase 2 · Exenatide
NCT00456300 trial results
The Role of Exenatide in Type 1 Diabetes Mellitus
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 (mmol*L/min), 0-120 minutes post-dose. Exenatide 1.25 mcg + Insulin: 49; Exenatide 2.5 mcg + Insulin: 44; Insulin Monotherapy: 379.
- Participants
- 11
- Status
- completed
- Completed
- 2009-03
- Sponsor
- Montefiore Medical Center
As posted on ClinicalTrials.gov (NCT00456300), updated at source Feb 26, 2019. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT00456300
Percent of participants affected, 0-120 minutes post-dose. The most common events the registry lists.
| Event | Exenatide 1.25 mcg + Insulin | Exenatide 2.5 mcg + Insulin | Insulin Monotherapy |
|---|---|---|---|
| Any serious event | 0% | 0% | 0% |
| Hypoglycemia | 11.1% | 0% | 0% |
The trial
How NCT00456300 was run
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.
- 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
- 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
- Insulin: Each subject received a baseline study with insulin alone
Who could join the trial
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.
Published papers
Papers from NCT00456300
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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