At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 70 enrolled
Drug / intervention
Nasal Glucagon +1 moredrug
Likely dose
Not stated in record
Key inclusion· 2
- ✓Diagnosis of Type 1 Diabetes Mellitus for at least 2 years
- ✓Receiving daily insulin since the time of diagnosis
Key exclusion· 8
- ✕History of hypersensitivity to glucagon or related products, or severe hypersensitivity reactions such as angioedema to any drugs
- ✕History of pheochromocytoma (adrenal gland tumor) or insulinoma
- ✕Episode of severe hypoglycemia (requiring assistance of another person) in the 1 month prior to enrollment
- ✕History of epilepsy or seizure disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of Glucagon Administered by Either the Nasal (LY900018) or Intra-muscular (GlucaGen®) Routes in Adult Patients With Type 1 Diabetes Mellitus During Controlled Insulin-Induced Hypoglycemia
In Brief
A Phase 1 clinical trial evaluating Nasal Glucagon and Intramuscular Glucagon for Hypoglycemia and Diabetes Mellitus, Type 1. Completed, enrolled 70 participants across 2 sites.
Detailed Summary
The purpose of this study is to compare a needle-free treatment of hypoglycemia with nasal glucagon (study drug) to a marketed glucagon administered by the intramuscular (IM) route, in participants with type 1 diabetes mellitus (T1DM).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoglycemia, Diabetes Mellitus, Type 1
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartNov 2017
First PostedNov 2017
Primary CompletionDec 2017
Study CompletionJan 2018
TodayJul 2026
First PostedNov 13, 2017
Enrollment StartNov 10, 2017
Primary CompletionDec 17, 2017
Study CompletionJan 13, 2018
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 8.6 years ago
Interventions
Nasal Glucagondrug
Administered nasally
Intramuscular Glucagondrug
Administered IM