Primary outcomeMedian· 0-45 minutes after dosing
Time to Plasma Glucose Recovery.
| Group | Value (minutes) |
|---|---|
| Dasiglucagon 0.6 mg | 10.0 |
| Placebo | 35.0 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataTrial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
NCTNCT03688711 (opens ClinicalTrials.gov in a new tab)Other idZP4207-17145
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 45 participants (actual)
- Sponsor
- Zealand Pharma · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 1 Nov 2018
- Primary completion
- 11 Mar 2019
- Completion
- 11 Mar 2019
- First posted
- 28 Sept 2018
- Last update posted
- 19 May 2021
- Conditions
- Hypoglycemia · Diabetes Mellitus, Type 1
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201820192020
- Ph 3
Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
NCT036887111 Nov 2018 to 11 Mar 2019
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
Interventions
- DasiglucagonDrug
- PlaceboDrug
Arms2
Experimental
Dasiglucagon
single fixed dose (subcutaneous injection) of dasiglucagon
Placebo comparator
Placebo
single fixed dose (subcutaneous injection) of placebo
Primary outcomes1
Outcomes the sponsor listed as primary.
Time to Plasma Glucose Recovery.
Time frame · 0-45 minutes after dosing
Registry description
Plasma glucose recovery was defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline during the hypoglycemic clamp procedure without administration of rescue intravenous (IV) glucose. Patients who received rescue IV glucose before 45 minutes and patients not recovering within 45 minutes after dosing were censored at 45 minutes.
Secondary outcomes(11)
Plasma Glucose Recovery After Trial Drug Injection
Time frame · 0-30 minutes after dosing
Registry description
Plasma glucose recovery (patient has achieved increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L)) within 30 minutes, within 20 minutes, within 15 minutes, and within 10 minutes after trial drug injection without administration of rescue intravenous (IV) glucose.
Plasma Glucose Changes From Baseline
Time frame · 0-30 minutes after dosing
Registry description
Plasma glucose changes from baseline at 30 minutes, at 20 minutes, at 15 minutes, and at 10 minutes after trial drug injection or at the time of rescue (patient level).
Time to Target Plasma Glucose Concentration
Time frame · 0-45 minutes after dosing
Registry description
Time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) without administration of rescue intravenous glucose
Pharmacodynamics - Area Under the Effect Curve
Time frame · 0-30 minutes after dosing
Registry description
Plasma glucose response as area under the effect curve (AUE) above baseline from time zero to 30 minutes, AUE0-30min.
Pharmacokinetics - Area Under the Plasma Concentration Curve
Time frame · 0-90 minutes after dosing
Registry description
Area under the drug concentration curve (AUC) from time zero to 90 minutes, AUC0-90min
Pharmacokinetics - Area Under the Plasma Concentration Curve
Time frame · 0-120 minutes after dosing
Registry description
Area under the drug concentration curve (AUC) from time zero to 120 minutes, AUC0-120min
Pharmacokinetics - Maximum Plasma Concentration
Time frame · 0-120 minutes after dosing
Registry description
Maximum plasma dasiglucagon concentration (Cmax)
Pharmacokinetics - Time to Maximum Plasma Concentration
Time frame · 0-120 minutes after dosing
Registry description
Time to maximum plasma dasiglucagon concentration (tmax)
Immunogenicity - Occurrence of Anti-drug Antibodies
Time frame · 58 days
Registry description
Occurrence of antibodies against dasiglucagon. Presented as percentage of patients with antibodies.
Rescue Infusions of IV Glucose After Trial Drug Administration
Time frame · 0-45 minutes after dosing
Registry description
Presented as number of patients with rescue infusions of IV glucose after trial drug administration. This was a safety outcome measure. IV = intravenous
Time to First Rescue Infusion of IV Glucose After Trial Drug Administration
Time frame · 0-45 minutes after dosing
Registry description
Safety outcome measure: time to first rescue infusion of IV glucose after trial drug administration. IV = intravenous
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeCount of participants· 0-30 minutes after dosing
Plasma Glucose Recovery After Trial Drug Injection
| Group | Value (Participants) |
|---|---|
| Dasiglucagon 0.6 mg | 33 |
| Placebo | 5 |
Secondary outcomeMean· 0-30 minutes after dosing
Plasma Glucose Changes From Baseline
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Dasiglucagon 0.6 mg | 85.29 | 29.696 |
| Placebo | 15.14 | 9.328 |
Secondary outcomeMedian· 0-45 minutes after dosing
Time to Target Plasma Glucose Concentration
| Group | Value (minutes) |
|---|---|
| Dasiglucagon 0.6 mg | 9.0 |
| Placebo | 27.5 |
Secondary outcomeMean· 0-30 minutes after dosing
Pharmacodynamics - Area Under the Effect Curve
| Group | Value (hr*mg/dL) | Spread |
|---|---|---|
| Dasiglucagon 0.6 mg | 19.9 | 8.41 |
| Placebo | 2.67 | 3.06 |
Secondary outcomeGeometric mean· 0-90 minutes after dosing
Pharmacokinetics - Area Under the Plasma Concentration Curve
| Group | Value (hr*pmol/L) | Spread |
|---|---|---|
| Dasiglucagon 0.6 mg | 1480 | 34.6 |
Secondary outcomeGeometric mean· 0-120 minutes after dosing
Pharmacokinetics - Area Under the Plasma Concentration Curve
| Group | Value (hr*pmol/L) | Spread |
|---|---|---|
| Dasiglucagon 0.6 mg | 1780 | 31.6 |
Secondary outcomeGeometric mean· 0-120 minutes after dosing
Pharmacokinetics - Maximum Plasma Concentration
| Group | Value (pmol/L) | Spread |
|---|---|---|
| Dasiglucagon 0.6 mg | 1350 | 38.2 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Dasiglucagon 0.6 mgsingle fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue | 0 / 34 | 0 / 34 | 24 / 34 |
| Placebosingle fixed dose (subcutaneous injection) of placebo Placebo: Placebo for dasiglucagon | 0 / 10 | 0 / 10 | 3 / 10 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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