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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes

NCTNCT02081014 (opens ClinicalTrials.gov in a new tab)Other idXSMP-201Other id1R44DK096715-01A1

Overview

Status
Completed
Phase
Phase 2
Enrollment
13 participants (actual)
Sponsor
Xeris Pharmaceuticals · Industry
Design
Randomized · Single masking
Countries
1 country

United States

Start
Mar 2014
Primary completion
Nov 2014
Completion
Nov 2014
First posted
7 Mar 2014 (estimated)
Last update posted
5 Apr 2018
Conditions
Hypoglycemia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015
  1. Ph 2

    Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes

    NCT02081014

    Mar 2014 to Nov 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to moderate hypoglycemia, a complication of diabetes.

Interventions

  • G-Pen Mini™ (glucagon injection)Drug

Arms3

  • Experimental

    G-Pen Mini™ (glucagon injection) 75 ug

    G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart

  • Experimental

    G-Pen Mini™ (glucagon injection) 150 ug

    G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart

  • Experimental

    G-Pen Mini™ (glucagon injection) 300 ug

    G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Serious Adverse Events

    Time frame · From first dose until follow-up call, up to 7 weeks per subject

    Registry description

    Number of serious adverse events (SAEs) per treatment

Secondary outcomes(12)
  1. Glucagon Cmax (Fasting)

    Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection

    Registry description

    Pharmacokinetic parameter: Maximum concentration of glucagon

  2. Glucagon Cmax (Post-insulin)

    Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

    Registry description

    Pharmacokinetic parameter: Maximum concentration of glucagon

  3. Glucagon Area Under the Curve (AUC) (Fasting)

    Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

    Registry description

    Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes

  4. Glucagon AUC (Post-insulin)

    Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

    Registry description

    Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes

  5. Glucagon Tmax (Fasting)

    Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection

    Registry description

    Pharmacokinetic parameter: Time to reach maximum concentration of glucagon

  6. Glucagon Tmax (Post-insulin)

    Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

    Registry description

    Pharmacokinetic parameter: Time to reach maximum concentration of glucagon

  7. Glucose Cmax (Fasting)

    Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection

    Registry description

    Pharmacodynamic parameter: Maximum concentration of glucose

  8. Glucose Cmax (Post-insulin)

    Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

    Registry description

    Pharmacodynamic parameter: Maximum concentration of glucose

  9. Glucose AUC (Fasting)

    Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

    Registry description

    Pharmacodynamic parameter: baseline adjusted area under the glucagon concentration curve from 0 to 120 minutes

  10. Glucose AUC (Post-insulin)

    Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

    Registry description

    Pharmacodynamic parameter: baseline adjusted area under the glucose concentration curve from 0-120 minutes

  11. Glucose Tmax (Fasting)

    Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection

    Registry description

    Pharmacodynamic parameter: Time to reach maximum concentration of glucose

  12. Glucose Tmax (Post-insulin)

    Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

    Registry description

    Pharmacodynamic parameter: Time to reach maximum concentration of glucose

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 outcomeNumber· From first dose until follow-up call, up to 7 weeks per subject

Serious Adverse Events

GroupValue (participants)
G-Pen Mini™ (Glucagon Injection) 75 ug0
G-Pen Mini™ (Glucagon Injection) 150 ug0
G-Pen Mini™ (Glucagon Injection) 300 ug0
Secondary and other outcome results(7)
Secondary outcomeMean· Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection

Glucagon Cmax (Fasting)

GroupValue (pg/ml)Spread
G-Pen Mini™ (Glucagon Injection) 75 ug233.834
G-Pen Mini™ (Glucagon Injection) 150 ug380.734
G-Pen Mini™ (Glucagon Injection) 300 ug663.634
Secondary outcomeMean· Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

Glucagon Cmax (Post-insulin)

GroupValue (pg/ml)Spread
G-Pen Mini™ (Glucagon Injection) 75 ug253.430.1
G-Pen Mini™ (Glucagon Injection) 150 ug335.430.1
G-Pen Mini™ (Glucagon Injection) 300 ug561.729.9
Secondary outcomeMean· Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

Glucagon Area Under the Curve (AUC) (Fasting)

GroupValue ((pg/ml)*hour)Spread
G-Pen Mini™ (Glucagon Injection) 75 ug265.435.4
G-Pen Mini™ (Glucagon Injection) 150 ug389.635.4
G-Pen Mini™ (Glucagon Injection) 300 ug735.335.4
Secondary outcomeMean· Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

Glucagon AUC (Post-insulin)

GroupValue ((pg/ml)*hour)Spread
G-Pen Mini™ (Glucagon Injection) 75 ug277.429.9
G-Pen Mini™ (Glucagon Injection) 150 ug386.829.9
G-Pen Mini™ (Glucagon Injection) 300 ug635.329.7
Secondary outcomeMean· Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection

Glucagon Tmax (Fasting)

GroupValue (minutes)Spread
G-Pen Mini™ (Glucagon Injection) 75 ug29.23.6
G-Pen Mini™ (Glucagon Injection) 150 ug29.83.6
G-Pen Mini™ (Glucagon Injection) 300 ug36.53.6
Secondary outcomeMean· Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

Glucagon Tmax (Post-insulin)

GroupValue (minutes)Spread
G-Pen Mini™ (Glucagon Injection) 75 ug242.7
G-Pen Mini™ (Glucagon Injection) 150 ug33.12.7
G-Pen Mini™ (Glucagon Injection) 300 ug34.12.7
Secondary outcomeMean· Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection

Glucose Cmax (Fasting)

GroupValue (mg/dl)Spread
G-Pen Mini™ (Glucagon Injection) 75 ug155.111.2
G-Pen Mini™ (Glucagon Injection) 150 ug186.211.1
G-Pen Mini™ (Glucagon Injection) 300 ug213.511.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
G-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart–0 / 1210 / 12
G-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart–0 / 1211 / 12
G-Pen Mini™ (Glucagon Injection) 300 ugG-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart–0 / 1211 / 12

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

PubMed tag: none · 2016

6 results

Nonaqueous, Mini-Dose Glucagon for Treatment of Mild Hypoglycemia in Adults With Type 1 Diabetes: A Dose-Seeking Study.

Haymond et al. 2016Diabetes carecited by 34

PMID 26861921PMC4764034DOI 10.2337/dc15-2124PUB-26861921

Rights unknown6 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Male and female subjects on insulin infusion pump therapy for treatment of type 1 diabetes 2. Between the ages of 18 and 50 years of age, inclusive, at Screening. 3. Females of childbearing potential with a negative serum pregnancy test prior at screening and negative urine pregnancy tests prior to the Treatment visits, using an approved forms of contraception for the duration of participation in the study (i.e. until after last dose). 4. Male subjects are required to use a condom and another of the methods of contraception in #3 above starting at Randomization and for the duration of the study. 5. Hemoglobin A1c (HbA1c) \< 9.0 %. 6. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 7. Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures. Exclusion Criteria: 1. Clinical evidence of microvascular complication(s) other than mild microalbuminuria or history of mild non-proliferative retinopathy 2. Any chronic diseases or illness that interferes with glucose metabolism, except for T1DM, or medications other than hypothyroidism on appropriate thyroid hormone replacement. 3. Blood pressure (BP) readings at Screening where Systemic BP \<90 or \>140 mm Hg, and Diastolic BP \<50 or \>90 mm Hg. 4. Cardiovascular event within 6 months prior to screening such as unstable angina, acute coronary syndrome, myocardial infarction, therapeutic coronary procedure (e.g., stent placement, Percutaneous Transluminal Coronary Angioplasty (PTCA), Coronary Artery By-pass Grafting (CABG)), stroke or transient ischemic attack. 5. Study participants who are pregnant at Screening. 6. Breast feeding must be discontinued if a subject wishes to participate in this study. 7. Positive test for hepatitis B, hepatitis C, or HIV found at Screening. 8. Positive urine drug test for illicit drugs at Screening. 9. History of allergies to glucagon, glucagon-like products or to any of the excipients in the investigational formulation. 10. Known presence of hereditary problems of glycogen storage disease, galactose and /or lactose intolerance 11. Administration of glucagon more than once within the three (3) months prior to Screening 12. Subjects with any of the following abnormalities in clinical laboratory tests at Screening, confirmed by a single repeat, if necessary: * Hemoglobin (Hb) below the lower limits of normal for the laboratory * Total bilirubin above the upper limits of normal for the laboratory * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) above the upper limits of normal for the laboratory * Creatinine above the upper limits of normal for the laboratory 13. History of regular alcohol consumption as defined by alcohol intake in a quantity exceeding 7 drinks per week for females or 14 drinks per week for males, where 1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor. 14. 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 15. Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed red blood cells, platelets or quantities less than 500 mL are allowed at investigator discretion. 16. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

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