drugset / Trial / NCT04028960
IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase
Phase 2
Terminated
4 enrolled
HealthPartners Institute
International Diabetes Center at Park Nicollet · collabJuvenile Diabetes Research Foundation · collab
RandomizedCrossoverTriple-blindTreatment
Summary
The purpose of this study is to determine how Humulin-R regular insulin affects the body's ability to feel low blood sugar (hypoglycemia) when delivered intranasally compared to placebo in subjects with Type 1 Diabetes (T1D) with hypoglycemia awareness. The study will use continuous glucose monitoring (CGM) to collect this information. The study drug or placebo will be administered using an intranasal device.
Timeline
- Start
- 2019-10-23
- Primary completion
- 2020-04-08
- Completion
- 2020-04-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin | Protein / enzyme biologic | — | Intranasal |