Phase 2 N=20 Randomized Treatment

Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia

Diabetes Mellitus, Type 1

Bottom Line

View on ClinicalTrials.gov: NCT02411578 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcome: Primary: Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment — 58; 53 Hypoglycemic Events — p=0.99

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: G-Pen Mini™ (glucagon injection) (Drug); Glucose Tablets (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Jaeb Center for Health Research
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment	58; 53	0.99
SECONDARY Continuous Glucose Monitor (CGM) Minimum Glucose, Event Level	59; 56	0.34
SECONDARY CGM Maximum Glucose, Event Level	122; 139	0.21
SECONDARY CGM Mean Glucose, Event Level	95; 108	0.09
SECONDARY CGM Time in Range, Event Level	79; 79	0.49
SECONDARY CGM Time Below 70 mg/dL, Event Level	35; 33	0.95
SECONDARY CGM Minimum Glucose, Event Level	57; 56	0.78
SECONDARY CGM Maximum Glucose, Event Level	122; 139	0.21
SECONDARY CGM Mean Glucose, Event Level	95; 108	0.09
SECONDARY CGM Time in Range, Event Level	79; 79	0.49
SECONDARY CGM Time Below 70 mg/dL	20; 19	0.63
SECONDARY CGM Mean Glucose	143; 149	0.41
SECONDARY CGM Time in Range	71; 71	0.80
SECONDARY CGM Time Below 70	5; 4	0.13
SECONDARY CGM Coefficient of Variation	35; 36	0.70

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).

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of presumed autoimmune T1D and receiving daily insulin
Age: 18.0 to 160 mmHg systolic or >100 mmHg diastolic
Currently a high endurance exerciser or plans to perform high endurance exercise during study (from screening visit until study completion)
High endurance exerciser defined as a person who regularly competes in running, cycling, rowing, swimming or any other endurance-based activity for the purpose of competition (>2100 metabolic equivalent of task (MET) minutes per week [i.e. 7 METs x 60 minutes x 5 days a week, where 7 METs is equivalent to jogging])
Currently following a very low calorie or other weight-loss diet
Participation in other studies involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before screening for the current study or planning to participate in another such study during participation in the current study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02411578). 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.