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Safety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia

Information source: Locemia Solutions ULC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypoglycemia

Intervention: glucagon (Drug); Low dose novel formulation (Drug); high dose novel formulation (Drug); Medium dose novel formulation (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Locemia Solutions ULC

Official(s) and/or principal investigator(s):
Eric Sicard, MD, Principal Investigator, Affiliation: Algorithme Pharma Inc


Hypoglycemia is common in people with type 1 diabetes. Mild and moderate hypoglycaemia is normally treated by consuming oral carbohydrates. During an episode of severe hypoglycaemia however, the person with diabetes is unable to consume carbohydrates and requires help from another person. The current standard treatment for severe hypoglycemia is intravenous glucose or an injection of glucagon, which causes an increase of blood glucose, which allows the person with diabetes to recover sufficiently to consume carbohydrate. AMG Medical is investigating a novel formulation of glucagon which may be easier to administer than the currently available glucagon formulations. In this study, patients with Type 1 diabetes will receive injected insulin to reduce their blood glucose, and will then receive one of three doses of the new glucagon formulation or a dose of glucagon for injection, and their blood glucose will be measured for 3 hours. The study hypothesis is that the new glucagon formulation will be as effective as the current injected formulation at raising blood glucose levels within 15 minutes.

Clinical Details

Official title: Phase II Study to Investigate the Safety and Efficacy of 2 Dose Levels of a Novel Glucagon Formulation Compared to Commercially Available Glucagon in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Percentage of Responders

Participants With at Least One Adverse Event

Secondary outcome: Mean Peak Plasma Concentration (Cmax) of Glucose

Detailed description: On each study day patients will be admitted to the clinical site at least 10 hours prior to glucagon administration. Each patient will be weighed in a hospital gown in the evening prior to glucagon administration to adjust the insulin infusion rate individually. Blood glucose values will be measured using a bedside rapid glucose analyzer. Blood glucose levels will be controlled overnight prior to dosing. On the morning of dosing after a supervised overnight fast, hypoglycemia will be induced by IV insulin infusion prior to dosing. Glucose levels will be measured throughout the IV insulin infusion process and once a value of ≤3. 6 mmol/L is observed, the insulin infusion will be stopped and within 5 minutes, subjects will be treated with one of the four treatments. Serial blood sampling for PK (glucagon) and PD (glucose) assessments will be performed before and after glucagon administration. In addition to the blood sampling schedule for glucose PD measurement, glucose levels will also be measured regularly throughout the procedure with a beside glucose analyzer for safety monitoring of patients. Minimally, measurements will be performed at each PK/PD blood draw. For each study period administration sites will be closely evaluated for tolerability. Before departure about 6 hours after glucagon administration, the glucose and insulin dosing and their stabilization will be evaluated by the physician to ensure the safety of the patient. These procedures will be applied for each period of the study. Drug Administration Procedure In each study period, a single dose of glucagon will be administered in the morning after a 10-hour overnight fast and following insulin-induced hypoglycemia, using either the new glucagon formulation or glucagon for injection.

Treatments 1 and 2 and 3 - New formulation:

Treatment 4 - Subcutaneous administration:

The approved dose level of 1 mg of glucagon will be injected under the skin A nurse will be at the clinical site overnight before glucagon administration to ensure safety of the patients. In addition, the physician in charge will remain at the clinical site from the start of the insulin infusion in the morning until at least the first 6 hours following each glucagon administration to ensure patients are re-stabilized in their regular insulin medication before departure. The physician in charge will also remain available at all times during the entire period of the study. End of the study The following post-study tests will be performed after the collection of the last blood sample of the study.

- Physical examination

- Laboratory tests

- Biochemistry

- Hematology

- Urinalysis

- HCG beta serum pregnancy test (female patients).

- 12-lead ECG


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- History of type 1 diabetes between 2 and 30 years

- Receiving daily insulin injections or insulin pump therapy for at least 2 years

- If patient is taking Lantus, Levemir or equivalent once-daily in the evening as basal

insulin, must be willing to transition to once-daily in the morning at least 48 hours prior to 1st dosing, and to follow this dosing regimen for the entire duration of the study

- Body mass index (BMI) greater than or equal to 20. 00 and below or equal to 33. 00


- Female patients must not be pregnant, and must be using effective contraception.

- Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10

cigarettes or less per day for at least 3 months before day 1 of this study. An ex smoker is defined as someone who completely stopped smoking for at least 6 months before day 1 of this study Exclusion Criteria:

- History of an episode of severe hypoglycemia (as defined by an episode that required

third party assistance for treatment) in the previous 6 months before day 1 of this study

- Score ≥4 on the Clarke Hypoglycemia Awareness survey at screening

- Presence or history of pheochromocytoma (i. e. adrenal gland tumor)

- Presence or history of significant upper respiratory or allergic (i. e., seasonal

rhinitis) disease

- Presence of clinically significant findings on nasal examination and bilateral

anterior rhinoscopy

- Known presence of hereditary problems of galactose and /or lactose intolerance

- History of significant hypersensitivity to glucagon or any related products as well

as severe hypersensitivity reactions (like angioedema) to any drugs

Locations and Contacts

Algorithme Pharma, Montreal, Quebec H3P 3P1, Canada
Additional Information

Starting date: March 2012
Last updated: August 9, 2014

Page last updated: August 23, 2015

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