Phase 2
Completed N=20
Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT02411578 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: 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
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).
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 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 |
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
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. Informational only — not medical advice.