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NCT02018627
Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon
Phase 2/Phase 3 trial testing Xeris glucagon in Type 1 Diabetes in 20 participants. Completed in 2 August 2018.
2 August 2018
Quick facts
| Lead sponsor | Steven J. Russell, MD, PhD |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 April 2014 |
| Primary completion | 2 August 2018 |
| Estimated completion | 2 August 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Xeris glucagon — full drug profile →
- Lilly glucagon — full drug profile →
Conditions studied
- Type 1 Diabetes — all drugs for Type 1 Diabetes →
Sponsor
Steven J. Russell, MD, PhD — full company profile →
Who can join
Adults 21 to 80, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Tmax
Time frame: every 2 minutes for 1 hour post-dose of each glucagon
tmax for Xeris vs. Lilly (non-inferiority)
Sponsor's own description
This study will test the hypothesis that micro-doses of Xerisol Glucagon (Xeris Pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of Glucagon for Injection (Eli Lilly).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02018627
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Type 1 Diabetes
Currently open trials in the same condition.
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- NCT07457580 — Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) · recruiting
- NCT07212179 — Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 · NA · recruiting
- NCT07287943 — To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes. · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02018627 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Steven J. Russell, MD, PhD
- Last refreshed: 17 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02018627.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing