Study of LY2409021 in Participants With Type 1 Diabetes
Summary
This study involves taking a single dose of 100 milligrams (mg) or 300 mg LY2409021 or placebo (an inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if this drug will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study includes a 7-day hospitalization period at the clinical research unit (CRU) and will involve screening within 30 days of the start of the study as well as telephone consultations within 5 days after discharge from the CRU.
Timeline
- Start
- 2012-07
- Primary completion
- 2012-09
- Completion
- 2012-09
Outcome
Missed primary endpoint
registry analysis (superiority or other test); 100 mg LY2409021; p = 0.0542; Mean Difference (Net) -5.84 (95% CI -11.82 to 0.14); t-test, 1 sided NCT01640834 ↗
registry analysis (superiority or other test); 300 mg LY2409021; p = 0.0826; Mean Difference (Net) -6.89 (95% CI -14.95 to 1.16); t-test, 1 sided NCT01640834 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADOMEGLIVANT | Small molecule | 100 mg | Oral |
| Subject | ADOMEGLIVANT | Small molecule | 300 mg | Oral |
| Background | Glucagon | Peptide | 1 mg | Intramuscular |