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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02081014
Recruitment Status : Completed
First Posted : March 7, 2014
Results First Posted : May 16, 2016
Last Update Posted : April 5, 2018
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Emissary International LLC
Information provided by (Responsible Party):
Xeris Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypoglycemia Drug: G-Pen Mini™ (glucagon injection) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Phase 2a, Blinded, 3-Way Crossover Dose-Ranging Study With G-Pen Mini™ (Glucagon Injection) to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Type 1 Diabetes Mellitus (T1DM)
Study Start Date : March 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: G-Pen Mini™ (glucagon injection) 75 ug
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
Drug: G-Pen Mini™ (glucagon injection)
stable, pre-mixed, liquid glucagon for subcutaneous injection
Other Name: mini-dose glucagon

Experimental: G-Pen Mini™ (glucagon injection) 150 ug
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
Drug: G-Pen Mini™ (glucagon injection)
stable, pre-mixed, liquid glucagon for subcutaneous injection
Other Name: mini-dose glucagon

Experimental: G-Pen Mini™ (glucagon injection) 300 ug
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
Drug: G-Pen Mini™ (glucagon injection)
stable, pre-mixed, liquid glucagon for subcutaneous injection
Other Name: mini-dose glucagon




Primary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: From first dose until follow-up call, up to 7 weeks per subject ]
    Number of serious adverse events (SAEs) per treatment


Secondary Outcome Measures :
  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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Pharmacodynamic parameter: Time to reach maximum concentration of glucose



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081014


Locations
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United States, Texas
Baylor College of Medicine, Children's Nutritional Research Center, Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Xeris Pharmaceuticals
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Emissary International LLC
Investigators
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Principal Investigator: Morey W Haymond, MD Baylor College of Medicine
Publications of Results:
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Responsible Party: Xeris Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02081014    
Other Study ID Numbers: XSMP-201
1R44DK096715-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2014    Key Record Dates
Results First Posted: May 16, 2016
Last Update Posted: April 5, 2018
Last Verified: March 2018
Keywords provided by Xeris Pharmaceuticals:
Hypoglycemia
Glucagon
Diabetes
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins