TerminatedPhase 2

Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses

Stopped: Primary endpoint was not met

United States49 participantsStarted 2018-03-15

Plain-language summary

This is a prospective, randomized, controlled, double-blind, parallel 4-group trial with the primary analysis after 4 weeks of treatment with continuous subcutaneous glucagon infusion (CSGI) or placebo. After a 1-week qualification on continuous glucose monitoring (CGM), subjects will have their baseline hypoglycemia counter-regulatory response hormones quantified using a step-wise hypoglycemia induction procedure. Subjects meeting eligibility requirements will be randomized to 1 of 4 treatment groups, 2 glucagon, 2 placebo. Subjects will receive blinded study drug for 4 weeks, and they will be followed for an additional 26 weeks post-treatment. Subjects' counter-regulatory hormone response will be measured at baseline, the end of treatment (4 weeks), and 13 and 26 weeks after treatment ends.

Who can participate

Age range21 Years – 64 Years

SexALL

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Inclusion criteria

✓. Males or females diagnosed with type 1 diabetes mellitus for at least 24 months.
✓. Random serum C-peptide concentration \< 0.5 ng/ml at Screening.
✓. Current use of multiple daily dosing insulin treatment \< 1 U/(kg\*day) total daily dose either administered with subcutaneous injections or continuous subcutaneous insulin infusion (CSII).
✓. Recurrent severe hypoglycemia as defined by minimally two events during the last year and at least one the last six months requiring not merely receiving third party intervention and either confirmation with a measured glucose \< 50 mg/dl, or prompt recovery from impaired consciousness. Events must be documented in patient chart prior to study entry. Events induced as a part of clinical diagnostics or experimentation do not qualify.
✓. Performs monitoring of glucose minimally 3 times a day. Patients using continuous glucose monitoring for monitoring should continue to do so during the course of the study.
✓. Age 21-64 years, inclusive, at screening.
✓. Willingness to provide informed consent and follow all study procedures, including using the Medtronic smart phone application "iPRO2mylog" for diabetes data logging and attending all scheduled visits.

Exclusion criteria

What they're measuring

Plasma Epinephrine

Timeframe: 0-30 minutes

Trial details

NCT IDNCT03490942

SponsorXeris Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-04

Results submitted2020-11-04

View on ClinicalTrials.gov More Hypoglycemia Unawareness trials