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Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon

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ClinicalTrials.gov Identifier: NCT02018627
Recruitment Status : Active, not recruiting
First Posted : December 23, 2013
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Steven J. Russell, MD, PhD, Massachusetts General Hospital

Brief Summary:
This study will test the hypothesis that micro-doses of Xerisol Glucagon (Xeris Pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of Glucagon for Injection (Eli Lilly).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Xeris glucagon Drug: Lilly glucagon Phase 2 Phase 3

Detailed Description:
This study will test the hypothesis that micro-doses of a new formulation of stable glucagon, Xerisol Glucagon (Xeris Pharmaceuticals), will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of a freshly reconstituted formulation of glucagon that has poor stability in solution, Glucagon for Injection (Eli Lilly).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon
Study Start Date : April 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Xeris glucagon
Xeris glucagon 50 micrograms, subcutaneous injection
Drug: Xeris glucagon
The subject is given an injection of xeris glucagon
Active Comparator: Lilly glucagon
Lilly glucagon 30 micrograms, subcutaneous injection
Drug: Lilly glucagon
The subject is given an injection of lilly glucagon



Primary Outcome Measures :
  1. tmax [ Time Frame: 1 day visit ]
    tmax for Xeris vs. Lilly (non-inferiority)


Secondary Outcome Measures :
  1. AOCGIR [ Time Frame: 1 day visit ]
    Area over the curve for glucose infusion rate in the hour following administration (AOCGIR) for Xeris vs. Lilly (non-inferiority)

  2. GIRmax [ Time Frame: 1 day visit ]
    Maximal glucose infusion rate (GIRmax) for Xeris vs. Lilly (non-inferiority)

  3. t½max [ Time Frame: 1 day visit ]
    Glucagon t½max for Xeris vs. Lilly (non-inferiority)

  4. Injection pain [ Time Frame: immediately after injection ]

    Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly:

    -Injection pain on a 10 cm standard VAS: 0 = no pain, 10 = worst imaginable pain


  5. Injection site erythema [ Time Frame: within 1 hour of injection ]

    Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly:

    -Injection site erythema or other local reaction, maximum diameter within 1 hour of injection


  6. Maximal nausea [ Time Frame: within 1 hour of injection ]

    Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly:

    -Maximal nausea within 1 hour of injection on a 10 cm VAS: no nausea = 0, vomiting = 10


  7. Dermal response (Draize scale for erythema and eschar formation) [ Time Frame: within 1 hour of injection ]
    Grade on the erythema and eschar formation portion of the Draize scale for dermal response

  8. Dermal response (Draize scale grade for edema formation) [ Time Frame: within 1 hour of injection ]
    Grade on the edema formation portion of the Draize scale for dermal response



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 21 to 80 years old with type 1 diabetes for at least one year.
  • Diabetes managed using an insulin infusion pump using rapid-acting insulin such as insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least one week prior to enrollment.

Exclusion Criteria:

  • Unable to provide informed consent.
  • Unable to comply with study procedures.
  • Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the clamp study or the safety of the subject.
  • Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.
  • End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
  • Hemoglobin < 11.5 gm/dl.
  • History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor (paroxysms of tachycardia, pallor, or headache; personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease; episodic or treatment of refractory hypertension, defined as requiring 4 or more medications to achieve normotension).
  • History of adverse reaction to glucagon (including allergy) besides nausea, vomiting, or headache.
  • Inadequate venous access as determined by study nurse or physician at time of screening.
  • Liver failure or cirrhosis.
  • Any other factors that, in the judgment of the principal investigator, would interfere with the safe completion of the study procedures.

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): NCT02018627


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Steven J. Russell, MD, PhD
Investigators
Principal Investigator: Steven J Russell, MD, PhD Massachusetts General Hospital

Responsible Party: Steven J. Russell, MD, PhD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02018627     History of Changes
Other Study ID Numbers: 2013P002549
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Steven J. Russell, MD, PhD, Massachusetts General Hospital:
bionic pancreas
artificial pancreas
insulin
glucagon
clamp

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins