CompletedPhase 2

Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia

United States26 participantsStarted 2015-09

Plain-language summary

The purpose of this study is to determine if a small dose of glucagon (mini-dose glucagon) is effective for the treatment of non-severe hypoglycemia in adults with type 1 diabetes (T1D).

Who can participate

Age range18 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Clinical diagnosis of presumed autoimmune T1D and receiving daily insulin
✓. Age: 18.0 to \< 65.0 years
✓. Duration of T1D: ≥2.0 years
✓. Body mass index 20.0 to \<35.0 kg/m2 and weight 110 to \<250 lbs
✓. HbA1c \<8.5% (point of care or local lab, within past month)
✓. Using continuous subcutaneous insulin infusion (CSII) therapy (i.e., insulin pump) for at least 3 months, with no plans to discontinue use during the study (and no use of active low glucose suspend feature within the last 4 weeks)
✓. Using continuous glucose monitor ≥6 days/week in the last 4 weeks, with no plans to discontinue continuous glucose monitor use during the study
✓. Continuous glucose monitor glucose level \<70 mg/dl during daytime hours (e.g., 8am - 10pm) on at least 7 of the past 28 days (a modification can be made for participants with non-traditional waking hours) evaluated from downloaded CGM data

Exclusion criteria

✕. More than 1 severe hypoglycemic episode in the past 12 months (as defined by an episode that required third party assistance for treatment)
✕. More than 1 episode of diabetic ketoacidosis in the past 12 months (as defined by an episode diagnosed as diabetic ketoacidosis that required treatment in an emergency department or hospitalization)
✕. Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any medical condition which, in the judgment of the investigator, could potentiate or predispose to undesired effects or could interfere with the absorption, distribution, metabolism, or excretion of glucagon or ability to respond appropriately to mild to moderate hypoglycemia.
✕. Known presence of hereditary problems of glycogen storage disease, galactose and/or lactose intolerance
✕. Males with alcohol use in excess of 3 or more drinks per day, on average and females with alcohol use in excess of 2 or more drinks per day, on average
✕. Use of non-insulin anti-diabetic medications
✕. Use of daily systemic beta-blocker
✕. Use of beta-adrenergic agonists, theophylline (or other methylxanthines)

What they're measuring

Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment

Timeframe: 30 minutes

Trial details

NCT IDNCT02411578

SponsorJaeb Center for Health Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-04

Results submitted2017-08-03

View on ClinicalTrials.gov More Diabetes Mellitus, Type 1 trials