Phase 3
Completed N=45
Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
Hypoglycemia · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT03688711 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Time to Plasma Glucose Recovery. — 10.0; 35.0 minutes — p=<0.0001
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (T1DM) compared to placebo
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Plasma Glucose Recovery. |
10.0; 35.0 | <0.0001 sig |
| SECONDARY Plasma Glucose Recovery After Trial Drug Injection |
33; 5; 32; 1; 30; 0 | 0.0012 sig |
| SECONDARY Plasma Glucose Changes From Baseline |
85.29; 15.14; 52.95; 9.67; 41.62; 5.23 | <0.0001 sig |
| SECONDARY Time to Target Plasma Glucose Concentration |
9.0; 27.5 | <0.0001 sig |
| SECONDARY Pharmacodynamics - Area Under the Effect Curve |
19.9; 2.67 | <0.0001 sig |
| SECONDARY Pharmacokinetics - Area Under the Plasma Concentration Curve |
1780 | — |
| SECONDARY Pharmacokinetics - Area Under the Plasma Concentration Curve |
1780 | — |
| SECONDARY Pharmacokinetics - Maximum Plasma Concentration |
1350 | — |
| SECONDARY Pharmacokinetics - Time to Maximum Plasma Concentration |
35 | — |
| SECONDARY Immunogenicity - Occurrence of Anti-drug Antibodies |
0; 0 | — |
| SECONDARY Rescue Infusions of IV Glucose After Trial Drug Administration |
1; 1 | — |
| SECONDARY Time to First Rescue Infusion of IV Glucose After Trial Drug Administration |
10; 14 | — |
Eligibility Criteria
Inclusion Criteria
- Female or male subjects with T1DM for at least 1 year; diagnostic criteria as defined by the American Diabetes Association (3).
- Treated with insulin for T1DM for at least 1 year and with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening
- Hemoglobin A1c <10%.
- Aged between 18 and 75 years, both inclusive.
Exclusion Criteria
- Previous participation in a clinical trial within the dasiglucagon in the rescue treatment of hypoglycemia program.
- Known or suspected allergy to trial drug(s) or related products.
- History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema).
- Previous participation in this trial. Participation being defined by signing the informed consent document.
Data sourced from ClinicalTrials.gov (NCT03688711). 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.