Primary outcomeCount of participants· At 30 minutes following administration of study drug
Hypoglycemia Rescue: Intent-to-Treat Population
| Group | Value (Participants) |
|---|---|
| G-Pen | 74 |
| Lilly Glucagon | 79 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataSafety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics
NCTNCT02656069 (opens ClinicalTrials.gov in a new tab)Other idXSGP-301
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 80 participants (actual)
- Sponsor
- Xeris Pharmaceuticals · Industry
- Design
- Randomized · Triple masking
- Countries
2 countries
United States, Canada
- Start
- 15 Mar 2017
- Primary completion
- 14 Aug 2017
- Completion
- 25 Sept 2017
- First posted
- 14 Jan 2016 (estimated)
- Last update posted
- 30 Oct 2018
- 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
20172018
- Ph 3
Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics
NCT0265606915 Mar 2017 to 25 Sept 2017
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen (glucagon injection) to Lilly Glucagon (glucagon for injection \[rDNA origin\]) for hypoglycemia rescue of adult patients with type 1 diabetes.
Interventions
- G-Pen (glucagon injection)Drug
- Lilly Glucagon (glucagon injection [rDNA origin])Drug
Arms2
Other
G-Pen first, then Lilly Glucagon
A single 1 mg subcutaneous (SC) injection of G-Pen (glucagon injection) with a 7-28 day wash-out, followed by a single 1 mg SC injection of Lilly Glucagon (glucagon injection \[rDNA origin\])
Other
Lilly Glucagon first, then G-Pen
A single 1 mg SC injection of Lilly Glucagon (glucagon injection \[rDNA origin\]) with a 7-28 day wash-out, followed by a single 1 mg SC injection of G-Pen (glucagon injection)
Primary outcomes3
Outcomes the sponsor listed as primary.
Hypoglycemia Rescue: Intent-to-Treat Population
Time frame · At 30 minutes following administration of study drug
Registry description
Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon
Hypoglycemia Rescue: Per Protocol Population
Time frame · At 30 minutes following administration of study drug
Registry description
Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon
Hypoglycemia Rescue: Alternate Glucose Response Definition
Time frame · At 30 minutes following administration of study drug
Registry description
Number of subjects with either an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL or an increase in from baseline in plasma glucose concentration of at least 20 mg/dL within 30 minutes after administration of glucagon
Secondary outcomes(6)
Plasma Glucose Area Under the Curve (AUC)
Time frame · At -5, 0, 10, 20, 30, 45, 60, and 90 minutes following administration of glucagon
Registry description
Pharmacodynamic endpoint of plasma glucose AUC from baseline to 90 minutes following administration of glucagon
Plasma Glucose Maximum Concentration (Cmax)
Time frame · At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon
Registry description
Pharmacodynamic endpoint of plasma glucose Cmax from baseline to 4 hours following administration of glucagon
Plasma Glucose Time to Maximum Concentration (Tmax)
Time frame · At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon
Registry description
Pharmacodynamic endpoint of plasma glucose Tmax from baseline to 4 hours following administration of glucagon
Plasma Glucose Time to Concentration > 70 mg/dL
Time frame · At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon
Registry description
Pharmacodynamic endpoint of time to achieve a plasma glucose concentration \> 70 mg/dL following administration of glucagon
Time to Resolution of Hypoglycemia Symptoms
Time frame · At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon
Registry description
Time to resolution of mean autonomic, mean neuroglycopenic and mean total hypoglycemia symptom scores from baseline through 90 minutes following administration of glucagon.
Global Assessment of Hypoglycemia
Time frame · At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon
Registry description
Time to resolution of the overall sensation of hypoglycemia following administration of glucagon
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeCount of participants· At 30 minutes following administration of study drug
Hypoglycemia Rescue: Per Protocol Population
| Group | Value (Participants) |
|---|---|
| G-Pen | 74 |
| Lilly Glucagon | 78 |
Primary outcomeCount of participants· At 30 minutes following administration of study drug
Hypoglycemia Rescue: Alternate Glucose Response Definition
| Group | Value (Participants) |
|---|---|
| G-Pen | 76 |
| Lilly Glucagon | 79 |
Secondary and other outcome results(5)
Secondary outcomeMean· At -5, 0, 10, 20, 30, 45, 60, and 90 minutes following administration of glucagon
Plasma Glucose Area Under the Curve (AUC)
| Group | Value (mg*min/dL) | Spread |
|---|---|---|
| G-Pen | 11651.4 | 2406.9 |
| Lilly Glucagon | 12260.4 | 2134.2 |
Secondary outcomeMean· At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon
Plasma Glucose Maximum Concentration (Cmax)
| Group | Value (mg/dL) | Spread |
|---|---|---|
| G-Pen | 202.7 | 41.8 |
| Lilly Glucagon | 193.5 | 42.2 |
Secondary outcomeMean· At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon
Plasma Glucose Time to Maximum Concentration (Tmax)
| Group | Value (minutes) | Spread |
|---|---|---|
| G-Pen | 111.3 | 33.5 |
| Lilly Glucagon | 100.4 | 42.7 |
Secondary outcomeMean· At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon
Plasma Glucose Time to Concentration > 70 mg/dL
| Group | Value (minutes) | Spread |
|---|---|---|
| G-Pen | 19.9 | 8.5 |
| Lilly Glucagon | 14.2 | 4.3 |
Secondary outcomeMean· At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon
Time to Resolution of Hypoglycemia Symptoms
| Group | Value (minutes) | Spread |
|---|---|---|
| G-Pen | 16.0 | 11.5 |
| Lilly Glucagon | 14.2 | 9.4 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| G-PenA single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection) | 0 / 78 | 0 / 78 | 24 / 78 |
| Lilly GlucagonA single 1 mg subcutaneous (SC) injection of Lilly Glucagon | 0 / 79 | 1 / 79 | 16 / 79 |
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
5 results
Comparison of a ready-to-use liquid glucagon injection administered by autoinjector to glucagon emergency kit for the symptomatic relief of severe hypoglycemia: two randomized crossover non-inferiority studies.
Christiansen et al. 2021BMJ open diabetes research & carecited by 19
PMID 34620618PMC8499286DOI 10.1136/bmjdrc-2021-002137PUB-34620618
Free to read · publisher termsCC BY-NC5 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:
* diagnosed with type 1 diabetes mellitus for at least 24 months
* usage of daily insulin treatment
* random serum C-peptide concentration \< 0.5 ng/mL
Exclusion Criteria:
* pregnant or nursing
* HbA1c \>9.0%
* renal insufficiency
* hepatic synthetic insufficiency
* aspartate or alanine aminotransferase \> 3 times the upper limit of normal
* hematocrit less than or equal to 30%
* use of \> 2.0 U/kg total insulin dose per day
* inadequate bilateral venous access in both arms
* congestive heart failure, New York Heart Association class II, III or IV
* active malignancy within 5 years, except basal cell or squamous cell skin cancers
* history of breast cancer or malignant melanoma
* major surgical operation within 30 days
* current seizure disorder.
* current bleeding disorder, treatment with warfarin, or platelet count below 50,000
* history of pheochromocytoma or disorder with increased risk of pheochromocytoma
* history of insulinoma
* history of glycogen storage disease.
* positive for HIV, hepatitis C virus or active hepatitis B virus infection
* whole blood donation of 1 pint (500 mL) within 8 weeks
* active substance or alcohol abuse
* administration of glucagon within 28 days
* participation in other studies involving an investigational drug or device within 30 days
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