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

NCT02081014 | Completed Phase 2 Results

• 2 other identifiers: XSMP-2011R44DK096715-01A1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoglycemia

Keywords

Hypoglycemia; Glucagon; Diabetes

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Events

  Number of serious adverse events (SAEs) per treatment

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

Secondary Outcomes (12)

• Glucagon Cmax (Fasting)

  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 (Post-insulin)

  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)

  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)

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

• Glucagon Tmax (Fasting)

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

Study Arms (3)

G-Pen Mini™ (glucagon injection) 75 ug

EXPERIMENTAL

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

Drug: G-Pen Mini™ (glucagon injection)

G-Pen Mini™ (glucagon injection) 150 ug

EXPERIMENTAL

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

Drug: G-Pen Mini™ (glucagon injection)

G-Pen Mini™ (glucagon injection) 300 ug

EXPERIMENTAL

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

Drug: G-Pen Mini™ (glucagon injection)

Interventions

G-Pen Mini™ (glucagon injection) DRUG

stable, pre-mixed, liquid glucagon for subcutaneous injection

Also known as: mini-dose glucagon

G-Pen Mini™ (glucagon injection) 150 ug; G-Pen Mini™ (glucagon injection) 300 ug; G-Pen Mini™ (glucagon injection) 75 ug

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects on insulin infusion pump therapy for treatment of type 1 diabetes
• Between the ages of 18 and 50 years of age, inclusive, at Screening.
• 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).
• 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.
• Hemoglobin A1c (HbA1c) \< 9.0 %.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures.

You may not qualify if:

• Clinical evidence of microvascular complication(s) other than mild microalbuminuria or history of mild non-proliferative retinopathy
• Any chronic diseases or illness that interferes with glucose metabolism, except for T1DM, or medications other than hypothyroidism on appropriate thyroid hormone replacement.
• Blood pressure (BP) readings at Screening where Systemic BP \<90 or \>140 mm Hg, and Diastolic BP \<50 or \>90 mm Hg.
• 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.
• Study participants who are pregnant at Screening.
• Breast feeding must be discontinued if a subject wishes to participate in this study.
• Positive test for hepatitis B, hepatitis C, or HIV found at Screening.
• Positive urine drug test for illicit drugs at Screening.
• History of allergies to glucagon, glucagon-like products or to any of the excipients in the investigational formulation.
• Known presence of hereditary problems of glycogen storage disease, galactose and /or lactose intolerance
• Administration of glucagon more than once within the three (3) months prior to Screening
• 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

Sponsors & Collaborators

• Xeris Pharmaceuticals: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Emissary International LLC: collaborator

Study Sites (1)

Baylor College of Medicine, Children's Nutritional Research Center, Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Haymond MW, Redondo MJ, McKay S, Cummins MJ, Newswanger B, Kinzell J, Prestrelski S. Nonaqueous, Mini-Dose Glucagon for Treatment of Mild Hypoglycemia in Adults With Type 1 Diabetes: A Dose-Seeking Study. Diabetes Care. 2016 Mar;39(3):465-8. doi: 10.2337/dc15-2124. Epub 2016 Feb 9.

  PMID: 26861921 RESULT

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus

Interventions

Glucagon

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Martin J. Cummins, VP Drug Development
• Organization: Xeris Pharmaceuticals, Inc.

mjcummins@xerispharma.com

512-498-2675

Study Officials

• Morey W Haymond, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 7, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 5, 2018
• Results First Posted: May 16, 2016

Record last verified: 2018-03

Locations

US (1)