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A Multiple Center, Open Label, Prospective Study to Evaluate the Effectiveness and Ease-Of-Use of AMG504-1 Administered in the Home or School Environments for Treating Hypoglycemia in Children and Adolescents With T1D
Up to fifty (50) children and adolescents with type 1 diabetes (T1D) aged 4 to ˂18 years at time of enrolment will be selected for inclusion in the study. The target is to obtain treatment response and user-experience data following use of Nasal Glucagon (LY900018) in treating episodes of hypoglycemia.
Details
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 26 |
| Start date | 2015-03 |
| Completion | 2015-08 |
Conditions
- Hypoglycemia
- Diabetes Mellitus
Interventions
- Nasal Glucagon
Primary outcomes
- Number of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration — Within 30 minutes after each drug administration for an episode of hypoglycemia
Responses to questions completed by the caregiver are used to assess this outcome. An episode of severe hypoglycemia is generally defined as an event associated with severe neuroglycopenia usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose) administered by a third party. In this study moderate hypoglycemia is defined as an episode wherein the child/adolescent with diabetes has symptoms and/or signs of neuroglycopenia and has a blood glucose ≤3.9 millimoles per liter (mmol/L) (70 milligram per deciliter \[mg/dL\]) based on a blood sample taken at or close to the time of treatment.
Countries
United States