Phase 3
N=129
Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia
Hypoglycemia · Diabetes Mellitus · Drug-Specific Antibodies
Bottom Line
View on ClinicalTrials.gov: NCT02171130 ↗Enrolled (actual)
129
Serious AEs
1.2%
Results posted
Oct 2019
Primary outcome: Primary: Percentage of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration — 95.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nasal Glucagon (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration |
95.7 | — |
| SECONDARY Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver |
2; 4; 4; 26; 143; 2 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) Reported Through the Nasal Score Questionnaire |
82.8 | — |
Summary
Up to two hundred (200) adult participants with type 1 diabetes (T1D) aged 18 to 75 years will be selected for inclusion in the study. The target is to obtain treatment response and user-experience data following use of nasal glucagon (AMG504-1) in treating episodes of hypoglycemia. The population will be enriched to include participants who suffer from impaired hypoglycemia awareness.
Eligibility Criteria
Inclusion Criteria
- Male or Female Person with diabetes (PWD) lives with or is in frequent contact with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia
- With a history of type 1 diabetes >1 year
- At least 18 years of age but not older than 75 years
- Body mass index (BMI) greater than or equal to 18.50 and below 35.00 kg/m2.
- PWD will be otherwise healthy according to medical history, general physical examination (including vital signs), nasal examination, and laboratory tests (biochemistry, hematology, and urinalysis).
- For female subjects, a urine pregnancy test must be negative.
Exclusion Criteria
- Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
- Use of a daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.
Data sourced from ClinicalTrials.gov (NCT02171130). 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.