Phase 3
Completed N=170
A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects
Hypoglycemia · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT03378635 ↗
Enrolled (actual)
170
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Time to Plasma Glucose Recovery — 10; 40; 12 minutes — p=<0.001
◆ Published Evidence
Established
52citations · ~10 / year
Dasiglucagon-A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia: Results of Phase 3 Randomized Double-Blind Clinical Trial.
Summary
The objective of the trial is to demonstrate superiority of dasiglucagon compared to placebo following a single subcutaneous dose administered to subjects with type 1 diabetes mellitus (T1DM) with insulin-induced hypoglycemia. Additionally to compare the glycemic response observed after administration dasiglucagon with that of GlucaGen®.
Linked Publications
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Dasiglucagon-A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia: Results of Phase 3 Randomized Double-Blind Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Plasma Glucose Recovery |
10; 40; 12 | <0.001 sig |
| SECONDARY Plasma Glucose Recovery |
82; 20; 43; 81; 6; 42 | <0.001 sig |
| SECONDARY Plasma Glucose Changes From Baseline |
90.9; 19.1; 88.5; 59.7; 8.7; 58.4 | <0.001 sig |
| SECONDARY Time to Target |
8; 25; 8 | <0.001 sig |
| SECONDARY Pharmacodynamics - Area Under the Effect Curve |
21.0; 3.57; 20.4 | <0.001 sig |
| SECONDARY Pharmacokinetics - Area Under the Plasma Concentration Curve |
1770; 1490 | 0.006 sig |
| SECONDARY Pharmacokinetics - Area Under the Plasma Concentration Curve |
1770; 1490 | 0.006 sig |
| SECONDARY Pharmacokinetics - Maximum Plasma Concentration |
1280; 1490 | — |
| SECONDARY Pharmacokinetics - Time to Maximum Plasma Concentration |
0.670; 0.250 | — |
| SECONDARY Immunogenicity - Occurence of Anti-drug Antibodies |
1; 0; 0; 0 | — |
| SECONDARY Rescue Infusion of IV Glucose During the Hypoglycemic Clamp Procedure |
0; 0; 0 | — |
| SECONDARY Time to First Rescue Infusion of IV Glucose |
— | — |
Eligibility Criteria
Inclusion Criteria
- Female or male subjects with type 1 diabetes mellitus (T1DM) for at least 1 year, diagnostic criteria as defined by the American Diabetes Association
- 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%
Exclusion Criteria
- Previously treated with dasiglucagon (previously referred to as ZP4207)
- Known or suspected allergy to trial product(s) or related products
- Females who are pregnant according to a positive pregnancy test, are actively attempting to get pregnant, or are lactating.
- History of hypoglycemic events associated with seizures in the last year prior to screening
- History of severe hypoglycemia in the last month prior to screening
- Active malignancy within the last 5 years
- Current bleeding disorder, including anti-coagulant treatment
- Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor)
- Use of a daily systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this trial
- Clinically significant abnormal ECG at screening as judged by the investigator
- Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening
- Surgery or trauma with significant blood loss within the last 2 months prior to screening
- A positive result in the alcohol and/or urine drug screen at the screening visit. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24 g alcohol per day for men, or more than 12 g alcohol per day for women
Data sourced from ClinicalTrials.gov (NCT03378635) and the linked publication. 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.