| Trial ID: | L2492 |
| Source ID: | NCT03439072
|
| Associated Drug: |
G-Pen
|
| Title: |
G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03439072/results
|
| Conditions: |
Insulin Hypoglycemia|Type 1 Diabetes Mellitus|Severe Hypoglycemia
|
| Interventions: |
DRUG: G-Pen|DRUG: Lilly Glucagon
|
| Outcome Measures: |
Primary: Number of Subjects With a Positive Glucose Response, Increase in plasma glucose concentration from below 50.0 mg/dL to greater than 70.0 mg/dL within 30 minutes after receiving glucagon, 0 to 30 minutes post dose | Secondary: Time for Positive Glucose Response, Time from administration of glucagon for plasma glucose to rise from below 50.0 mg/dL to above 70.0 mg/dL, 0 to 180 minutes post dose|Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Positive Glucose Increase, A positive response for this endpoint is a return of plasma glucose to \> 70 mg/dL or an increase in plasma glucose by ≥20 mg/dL within 30 minutes after receiving glucagon, 0 to 30 minutes post dose|Number of Subjects With a Positive Glucose Increase, Increase in plasma glucose by ≥ 20.0 mg/dL within 30 minutes after receiving glucagon, 0 to 30 minutes post dose|Time for Positive Glucose Increase, Time from administration of glucagon for plasma glucose to increase by ≥20 mg/dL from baseline, 0 to 180 minutes post dose|Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Relief of Neuroglycopenic Symptoms, A positive response for this endpoint is a return of plasma glucose to \> 70 mg/dL or clearance of all neuroglycopenic symptoms of hypoglycemia within 30 minutes after receiving glucagon. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness., 0 to 30 minutes post dose|Number of Subjects With Relief of Neuroglycopenic Symptoms, Clearance of all neuroglycopenic symptoms of hypoglycemia within 30 minutes after receiving glucagon. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness., 0 to 30 minutes post dose|Time to Resolution of Autonomic Symptoms, Time from administration of glucagon to complete resolution of 4 autonomic symptoms of hypoglycemia. Symptoms included: sweating, tremor, palpitations and feeling of nervousness., 0 to 180 minutes post dose|Time to Resolution of Neuroglycopenic Symptoms, Time from administration of glucagon to complete resolution of 4 neuroglycopenic symptoms of hypoglycemia. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness., 0 to 180 minutes post dose|Time to Resolution of the Feeling of Hypoglycemia, Time from administration of glucagon to resolution of the overall sensation of hypoglycemia. Subjects were asked to answer yes/no to the question, "Do you feel hypoglycemic?" The time point as which the subject first answered "no" was considered the time of resolution., 0 to 180 minutes post dose|Glucose AUC, Area under the curve for plasma glucose., 0 to 180 minutes post dose - Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose.|Glucose Cmax, Maximum concentration of plasma glucose., 0 to 180 minutes post dose - Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose.|Glucose Tmax, Time to maximum concentration of plasma glucose. Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose., 0 to 180 minutes post dose|Glucagon Preparation and Administration Time, Time required to prepare and inject glucagon as measured between a "decision to dose" and completion of the injection, 0 to 5 minutes pre-dose
|
| Sponsor/Collaborators: |
Sponsor: Xeris Pharmaceuticals | Collaborators: SGS S.A.|Integrated Medical Development
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
81
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-01-23
|
| Completion Date: |
2018-05-03
|
| Results First Posted: |
2019-05-30
|
| Last Update Posted: |
2020-02-17
|
| Locations: |
ProSciento, Inc., Chula Vista, California, 91911, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States|Rainier Clinical Research Center, Inc., Renton, Washington, 98057, United States|LMC ESD, Inc., Toronto, Ontario, M4G 3E8, Canada|Altasciences Algorithme Pharma, Montréal, Quebec, H3P 3P1, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT03439072
|
