Primary outcomeMedian· 0-45 minutes after dosing
Time to Plasma Glucose Recovery
| Group | Value (minutes) |
|---|---|
| Dasiglucagon 0.6 mg | 10 |
| Placebo | 40 |
| GlucaGen® 1.0 mg | 12 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects
NCTNCT03378635 (opens ClinicalTrials.gov in a new tab)Other idZP4207-16137
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 170 participants (actual)
- Sponsor
- Zealand Pharma · Industry
- Design
- Randomized · Quadruple masking
- Countries
4 countries
United States, Austria, Canada, Germany
- Start
- 7 Dec 2017
- Primary completion
- 27 Apr 2018
- Completion
- 25 May 2018
- First posted
- 20 Dec 2017
- Last update posted
- 10 Jun 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
201720182019
- Ph 3
A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects
NCT033786357 Dec 2017 to 25 May 2018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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®.
Interventions
- DasiglucagonDrug
- GlucaGenDrug
- PlaceboDrug
Arms3
Experimental
Dasiglucagon
Single fixed dose (s.c.injection) of dasiglucagon
Placebo comparator
Placebo
Single fixed dose (s.c.injection) of placebo
Active comparator
GlucaGen®
Single fixed dose (s.c.injection) of GlucaGen®
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 is defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose. The outcome measure used a Kaplan-Meier estimate with 95% confidence interval. Treatment groups without censoring utilized a distribution free method to compute the confidence interval for median time.
Secondary outcomes(11)
Plasma Glucose Recovery
Time frame · 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection
Registry description
Plasma glucose recovery within 30 minutes, within 20 minutes, within 15 minutes, and within 10 minutes after study drug injection without administration of rescue IV glucose. Plasma glucose recovery was defined as the first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose.
Plasma Glucose Changes From Baseline
Time frame · 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection
Registry description
Plasma glucose changes from baseline at 30 minutes, 20 minutes, 15 minutes and 10 minutes after study drug injection without administration of rescue intravenous glucose
Time to Target
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. The outcome measure used a Kaplan-Meier estimate with 95% confidence interval. Treatment groups without censoring utilized a distribution free method to compute the confidence interval for median time.
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. Samples were collected pre-dose, and at 4, 6, 8, 10, 12, 15, 17, 20, 25 and 30 minutes after dosing.
Pharmacokinetics - Area Under the Plasma Concentration Curve
Time frame · 0-90 minutes after dosing
Registry description
Area under the drug concentration curve from time zero to 90 minutes, AUC0-90min. To calculate the AUC the standard trapezoidal method was used, based on actual rather than nominal time points. Samples were collected pre-dose, and at 15, 30, 35, 40, 50, 60, 90 and 120 minutes after dosing.
Pharmacokinetics - Area Under the Plasma Concentration Curve
Time frame · 0-120 minutes after dosing
Registry description
Area under the drug concentration curve from time zero to 120 minutes, AUC0-120min. To calculate the AUC the standard trapezoidal method was used, based on actual rather than nominal time points. Samples were collected pre-dose, and at 15, 30, 35, 40, 50, 60, 90 and 120 minutes after dosing.
Pharmacokinetics - Maximum Plasma Concentration
Time frame · 0-120 minutes after dosing
Registry description
Maximum plasma drug concentration (Cmax). Maximum plasma drug concentration was determined as the maximum of all valid plasma dasiglucagon/glucagon concentrations. Samples were collected pre-dose, and at 15, 30, 35, 40, 50, 60, 90 and 120 minutes after dosing.
Pharmacokinetics - Time to Maximum Plasma Concentration
Time frame · 0-120 minutes after dosing
Registry description
Time to maximum plasma drug concentration (tmax). Median Tmax was determined as the time point where the maximum of all valid plasma dasiglucagon/glucagon concentration measurements for each measurement series was observed. Samples were collected pre-dose, and at 15, 30, 35, 40, 50, 60, 90 and 120 minutes after dosing.
Immunogenicity - Occurence of Anti-drug Antibodies
Time frame · 28 days
Registry description
Occurence of antibodies against dasiglucagon/GlucaGen
Rescue Infusion of IV Glucose During the Hypoglycemic Clamp Procedure
Time frame · 0-45 minutes after dosing
Registry description
Number of patients receiving administration of rescue infusion of IV glucose during the hypoglycemic clamp procedure. IV = intravenous
Time to First Rescue Infusion of IV Glucose
Time frame · 0-45 minutes after dosing
Registry description
Time to first rescue administration of rescue infusion of IV glucose. 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: assessed at 10, 15, 20 and 30 minutes after study drug injection
Plasma Glucose Recovery
| Group | Value (Participants) |
|---|---|
| Dasiglucagon 0.6 mg | 82 |
| Placebo | 20 |
| GlucaGen® 1.0 mg | 43 |
Secondary outcomeMean· 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection
Plasma Glucose Changes From Baseline
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Dasiglucagon 0.6 mg | 90.9 | 18.2 |
| Placebo | 19.1 | 13.0 |
| GlucaGen® 1.0 mg | 88.5 | 19.2 |
Secondary outcomeMedian· 0-45 minutes after dosing
Time to Target
| Group | Value (minutes) |
|---|---|
| Dasiglucagon 0.6 mg | 8 |
| Placebo | 25 |
| GlucaGen® 1.0 mg | 8 |
Secondary outcomeMean· 0-30 minutes after dosing
Pharmacodynamics - Area Under the Effect Curve
| Group | Value (mg*h/dL) | Spread |
|---|---|---|
| Dasiglucagon 0.6 mg | 21.0 | 5.26 |
| Placebo | 3.57 | 2.86 |
| GlucaGen® 1.0 mg | 20.4 | 5.49 |
Secondary outcomeGeometric mean· 0-90 minutes after dosing
Pharmacokinetics - Area Under the Plasma Concentration Curve
| Group | Value (pmol*h/L) | Spread |
|---|---|---|
| Dasiglucagon 0.6 mg | 1430 | 34.2 |
| GlucaGen® 1.0 mg | 1300 | 27.5 |
Secondary outcomeGeometric mean· 0-120 minutes after dosing
Pharmacokinetics - Area Under the Plasma Concentration Curve
| Group | Value (pmol*h/L) | Spread |
|---|---|---|
| Dasiglucagon 0.6 mg | 1770 | 31.2 |
| GlucaGen® 1.0 mg | 1490 | 27.2 |
Secondary outcomeGeometric mean· 0-120 minutes after dosing
Pharmacokinetics - Maximum Plasma Concentration
| Group | Value (pmol/L) | Spread |
|---|---|---|
| Dasiglucagon 0.6 mg | 1280 | 37.7 |
| GlucaGen® 1.0 mg | 1490 | 34.5 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Dasiglucagon 0.6 mgSingle fixed dose (s.c.injection) of dasiglucagon Dasiglucagon: Glucagon analog | 0 / 82 | 0 / 82 | 66 / 82 |
| PlaceboSingle fixed dose (s.c.injection) of placebo Placebo: Placebo for dasiglucagon | 0 / 43 | 0 / 43 | 14 / 43 |
| GlucaGen® 1.0 mgSingle fixed dose (s.c.injection) of GlucaGen® GlucaGen: Native glucagon | 0 / 43 | 0 / 43 | 32 / 43 |
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
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2021
6 results
Dasiglucagon-A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia: Results of Phase 3 Randomized Double-Blind Clinical Trial.
Pieber et al. 2021Diabetes carecited by 42
PMID 35239971PMC8247529DOI 10.2337/dc20-2995PUB-35239971
Rights unknown6 results
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 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
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