Primary outcomeCount of participants· At 30 minutes following administration of study drug
Severe Hypoglycemia Rescue
| Group | Value (Participants) |
|---|---|
| G-Pen | 127 |
| Novo Glucagon | 123 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataG-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes
NCTNCT03738865 (opens ClinicalTrials.gov in a new tab)Other idXSGP-304
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 132 participants (actual)
- Sponsor
- Xeris Pharmaceuticals · Industry
- Design
- Randomized · Single masking
- Countries
3 countries
United States, Austria, Canada
- Start
- 27 Sept 2018
- Primary completion
- 29 Mar 2019
- Completion
- 2 Apr 2019
- First posted
- 13 Nov 2018
- Last update posted
- 22 May 2020
- Conditions
- Insulin Hypoglycemia · Type 1 Diabetes Mellitus · Severe Hypoglycemia
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201820192020
- Ph 3
G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes
NCT0373886527 Sept 2018 to 2 Apr 2019
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus. The study involves two daytime clinical research center (CRC) visits with random assignment to receive G-Pen glucagon 1 mg during one period and Novo Glucagon 1 mg during the other. Each daytime visit is preceded by an overnight stay in the CRC. In the morning of the inpatient study visit, the subject is brought into a state of severe hypoglycemia through IV administration of regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose \< 54 mg/dL (3 mmol/L) is verified, the subject is administered a dose of G-Pen or Novo Glucagon via subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes post-dosing, with a value of \>70.0 mg/dL (3.89 mmol/L) or an increase of \> 20 mg/dL (\>1.11 mmol/L) within 30 minutes of glucagon administration indicating a positive response. After 3 hours, the subject is given a meal and discharged when medically stable. After a wash-out period of 7 to 28 days, subjects return to the CRC, and the procedures are repeated with each subject crossed over to the other treatment. A follow-up visit as a safety check is conducted 2-7 days following administration of the final dose of study drug.
Interventions
- G-PenDrug
- Novo GlucagonDrug
Arms2
Experimental
G-Pen followed by Novo Glucagon
1 mg G-Pen at the first treatment visit followed by 1 mg Novo Glucagon at the second treatment visit
Active comparator
Novo Glucagon followed by G-Pen
1 mg Novo Glucagon at the first treatment visit followed by 1 mg G-Pen at the second treatment visit
Primary outcomes1
Outcomes the sponsor listed as primary.
Severe Hypoglycemia Rescue
Time frame · At 30 minutes following administration of study drug
Registry description
Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration \> 20 mg/dL (\> 1.11 mmol/L) within 30 minutes after administration of glucagon
Secondary outcomes(4)
Plasma Glucose Response 1
Time frame · At 30 minutes following a decision to administer study drug
Registry description
Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) within 30 minutes of a decision to dose
Plasma Glucose Response 2
Time frame · At 0-30 minutes following a decision to administer study drug
Registry description
Number of subjects with an increase in plasma glucose concentration \> 20 mg/dL (\> 1.11 mmol/L) after administration of glucagon.
Administration Time
Time frame · At 0-10 minutes from a decision to administer study drug
Registry description
Mean time (minutes) to administer study drug from a decision to dose
Hypoglycemia Resolution
Time frame · At 0-90 minutes following administration of study drug
Registry description
Mean time (minutes) to complete resolution of the overall sensation of hypoglycemia from a decision to dose
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(4)
Secondary outcomeCount of participants· At 30 minutes following a decision to administer study drug
Plasma Glucose Response 1
| Group | Value (Participants) |
|---|---|
| G-Pen | 127 |
| Novo Glucagon | 123 |
Secondary outcomeCount of participants· At 0-30 minutes following a decision to administer study drug
Plasma Glucose Response 2
| Group | Value (Participants) |
|---|---|
| G-Pen | 127 |
| Novo Glucagon | 123 |
Secondary outcomeMean· At 0-10 minutes from a decision to administer study drug
Administration Time
| Group | Value (minutes) | Spread |
|---|---|---|
| G-Pen | 0.79 | 0.530 |
| Novo Glucagon | 1.76 | 0.678 |
Secondary outcomeMean· At 0-90 minutes following administration of study drug
Hypoglycemia Resolution
| Group | Value (minutes) | Spread |
|---|---|---|
| G-Pen | 15.69 | 7.428 |
| Novo Glucagon | 15.32 | 8.479 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| G-PenG-Pen: 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector | 0 / 127 | 0 / 127 | 67 / 127 |
| Novo GlucagonNovo Glucagon: 1 mg subcutaneous injection of Novo Glucagon (glucagon injection) | 0 / 123 | 0 / 123 | 57 / 123 |
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.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedPieber TR, Aronson R, Christiansen MP, Bode B, Junaidi K, Conoscenti V. Efficacy, safety, tolerability, and noninferiority phase 3 study of glucagon as a ready-to-use room temperature liquid stable formulation versus a lyophilised formulation for the biochemical recovery and symptomatic relief of insulin-induced severe hypoglycaemia in adults with type 1 diabetes. Diabetes Obes Metab. 2022 Jul;24(7):1394-1397. doi: 10.1111/dom.14699. Epub 2022 Apr 28. No abstract available. PMID 35322535
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:
1. Males and non-pregnant females diagnosed with type 1 diabetes (T1D) for at least 24 months.
2. Current usage of daily insulin treatment that includes having an assigned "correction factor" for managing hyperglycemia.
3. Age 18 to 75 years, inclusive.
4. Random serum C-peptide concentration \< 0.6 ng/mL.
5. Willingness to follow all study procedures, including attending all clinic visits.
6. Subject has provided informed consent as evidenced by a signed and dated informed consent form (ICF) completed before any trial-related activities occur.
Exclusion Criteria:
1. Pregnancy
2. Glycated hemoglobin (HbA1c) \> 10% at Screening.
3. Body mass index (BMI) \> 40 kg/m2.
4. Renal insufficiency (serum creatinine greater than 3.0 mg/dL) or end-stage renal disease requiring renal replacement therapy.
5. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or greater than 3 times the upper limit of normal.
6. Hepatic synthetic insufficiency as defined as a serum albumin of less than 3.0 g/dL.
7. Hematocrit \< 30%.
8. Blood pressure (BP) readings at Screening where systolic blood pressure (SBP) \< 90 or \> 150 mm Hg, and diastolic blood pressure (DBP) \< 50 or \> 100 mm Hg.
9. Clinically significant electrocardiogram (ECG) abnormalities.
10. Use of total insulin dose per day \> 2 U/kg.
11. Inadequate venous access.
12. Congestive heart failure, New York Heart Association (NYHA) class III or IV.
13. History of myocardial infarction, unstable angina, or revascularization within the past 6 months.
14. History of a cerebrovascular accident in the past 6 months or with major neurological deficits.
15. Active malignancy within 5 years from Screening, except basal cell or squamous cell skin cancers. Any history of breast cancer or malignant melanoma will be exclusionary.
16. Major surgical operation within 30 days prior to Screening.
17. Current seizure disorder (other than with suspect or documented hypoglycemia).
18. Current bleeding disorder, treatment with warfarin, or platelet count below 50 × 109 per liter.
19. History of pheochromocytoma or disorder with increased risk of pheochromocytoma (multiple endocrine neoplasia type 2 (MEN 2), neurofibromatosis, or Von Hippel-Lindau disease).
20. History of insulinoma.
21. History of allergies to glucagon or glucagon-like products, or any history of significant hypersensitivity to glucagon or any related products or to any of the excipients (DMSO and trehalose) in the investigational formulation.
22. History of glycogen storage disease.
23. Subject tests positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infection (hepatitis B surface antigen positive \[HBsAg+\]) at Screening.
24. Active substance other than tetrahydrocannabinol (THC) or alcohol abuse (more than 21 drinks per week for male subjects or 14 drinks per week for female subject).
25. Administration of glucagon within 7 days of Screening.
26. Participation in other studies involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before Screening for the current study and during participation in the current study.
27. Any other reason the Investigator deems exclusionary.
PepBank is a research reference. Talk to a doctor before you use any peptide.