Phase 2
Completed N=18
Safety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia
Source: ClinicalTrials.gov NCT01556594 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Percentage of Responders — 83.3; 25; 50; 75 percentage of participants
Summary
In this study, participants with Type 1 diabetes received insulin through an infusion into a vein to reduce their blood glucose, and then received nasal glucagon (NG) or glucagon for injection under the skin, and their blood glucose was measured for 3 hours.
The main objective of this study was to evaluate the safety and efficacy of intranasal and subcutaneous glucagon (SC) in reversing insulin-induced hypoglycemia in participants with type 1 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders |
83.3; 25; 50; 75 | — |
| PRIMARY Number of Participants With at Least One Adverse Event |
16; 9; 15; 8 | — |
| SECONDARY Maximum Concentration (Cmax) of Baseline-Adjusted Glucose |
5.68; 2.41; 3.46; 3.11 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose |
1.5; 0.67; 1.0; 1.0 | — |
| SECONDARY Maximum Change From Baseline Concentration (Cmax) of Glucagon |
3930; 504; 2370; 1360 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon |
0.33; 0.25; 0.33; 0.29 | — |
| SECONDARY Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon |
2390; 95.2; 886; 720 | — |
Eligibility Criteria
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 kg/m2
- 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
Data sourced from ClinicalTrials.gov (NCT01556594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.