Phase 2
N=9
Role of Exenatide in Type 1 Diabetes
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00456300 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: 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; 44; 379 mmol*L/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Exenatide (Drug); Insulin (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; 44; 379 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00456300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.