Phase 3
Completed N=13
Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon
Source: ClinicalTrials.gov NCT02018627 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Tmax — 23.8; 15.7 minutes
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tmax |
23.8; 15.7 | — |
| SECONDARY AOCGIR |
201.1; 132.2 | — |
| SECONDARY GIRmin |
2.9; 2.9 | — |
| SECONDARY t½Max |
11.3; 5.9 | — |
| SECONDARY Injection Pain |
13.8; 7.6 | — |
| SECONDARY Injection Site Erythema |
0; 0 | — |
| SECONDARY Maximal Nausea |
1.0; 2.3 | — |
| SECONDARY Dermal Response (Draize Scale for Erythema and Eschar Formation) |
0; 0 | — |
| SECONDARY Dermal Response (Draize Scale Grade for Edema Formation) |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age 21 to 80 years old with type 1 diabetes for at least one year.
- Diabetes managed using an insulin infusion pump using rapid-acting insulin such as insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least one week prior to enrollment.
Exclusion Criteria
- Unable to provide informed consent.
- Unable to comply with study procedures.
- Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the clamp study or the safety of the subject.
- Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.
- End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
- Hemoglobin < 11.5 gm/dl.
- History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor (paroxysms of tachycardia, pallor, or headache; personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease; episodic or treatment of refractory hypertension, defined as requiring 4 or more medications to achieve normotension).
- History of adverse reaction to glucagon (including allergy) besides nausea, vomiting, or headache.
- Inadequate venous access as determined by study nurse or physician at time of screening.
- Liver failure or cirrhosis.
- Any other factors that, in the judgment of the principal investigator, would interfere with the safe completion of the study procedures.
Data sourced from ClinicalTrials.gov (NCT02018627). 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. Informational only — not medical advice.