- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02081014
Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes
March 10, 2018 updated by: Xeris Pharmaceuticals
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Baylor College of Medicine, Children's Nutritional Research Center, Texas Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Creatinine above the upper limits of normal for the laboratory
- 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.
- 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
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / 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
|
stable, pre-mixed, liquid glucagon for subcutaneous injection
Other Names:
|
EXPERIMENTAL: G-Pen Mini™ (glucagon injection) 150 ug
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
|
stable, pre-mixed, liquid glucagon for subcutaneous injection
Other Names:
|
EXPERIMENTAL: G-Pen Mini™ (glucagon injection) 300 ug
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
|
stable, pre-mixed, liquid glucagon for subcutaneous injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From first dose until follow-up call, up to 7 weeks per subject
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
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
|
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)
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
|
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)
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
|
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)
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
|
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 (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
|
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
|
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
|
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 (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
|
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
|
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
|
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
|
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
|
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
|
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
|
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection
|
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
|
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Morey W Haymond, MD, Baylor College of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (ACTUAL)
November 1, 2014
Study Completion (ACTUAL)
November 1, 2014
Study Registration Dates
First Submitted
March 4, 2014
First Submitted That Met QC Criteria
March 4, 2014
First Posted (ESTIMATE)
March 7, 2014
Study Record Updates
Last Update Posted (ACTUAL)
April 5, 2018
Last Update Submitted That Met QC Criteria
March 10, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XSMP-201
- 1R44DK096715-01A1 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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