Primary outcomeNumber· Pre-dose; 30 minutes following glucagon administration
Percentage of Responders
| Group | Value (percentage of participants) |
|---|---|
| SC Glucagon | 83.3 |
| NG 1 mg | 25 |
| NG 2 mg | 50 |
| NG 3 mg | 75 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataSafety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia
Short name AMG102
NCTNCT01556594 (opens ClinicalTrials.gov in a new tab)Other id16416Other idI8R-MC-IGBAOther idAMG102
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 18 participants (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Canada
- Start
- Mar 2012
- Primary completion
- Jul 2012
- Completion
- Jul 2012
- First posted
- 16 Mar 2012 (estimated)
- Last update posted
- 23 Sept 2019
- Conditions
- Hypoglycemia
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20122013
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Nasal Glucagon 1 mgDrug
- Nasal Glucagon 2 mgDrug
- SC GlucagonDrug
- Nasal Glucagon 3 mgDrug
Arms4
Experimental
Nasal Glucagon 1 mg
Nasal glucagon (NG) administered as single dose of 1 milligram (mg).
Experimental
Nasal Glucagon 2 mg
NG administered as single dose of 2 mg.
Active comparator
SC Glucagon
Glucagon solution dose of 1 mg administered as a single subcutaneous (SC) injection.
Experimental
Nasal Glucagon 3 mg
NG administered as single dose of 3 mg (composed of one dose of 1 mg NG immediately followed by one dose of 2mg NG).
Primary outcomes2
Outcomes the sponsor listed as primary.
Percentage of Responders
Time frame · Pre-dose; 30 minutes following glucagon administration
Registry description
Participants with a blood glucose increment of ≥1.5 millimole per liter \[mmol/L) within 15 of nadir (5 minutes post dose) and for at least 10 minutes following nadir.
Number of Participants With at Least One Adverse Event
Time frame · Within 3 hours post glucagon administration
Registry description
Safety and tolerability evaluated through the assessment of adverse events. An AE was defined as any untoward medical occurrence in a clinical investigation subject administered the investigational product and which did not necessarily have a causal relationship with this treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Secondary outcomes(5)
Maximum Concentration (Cmax) of Baseline-Adjusted Glucose
Time frame · Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Time frame · Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Maximum Change From Baseline Concentration (Cmax) of Glucagon
Time frame · Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Time frame · Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon
Time frame · Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeCount of participants· Within 3 hours post glucagon administration
Number of Participants With at Least One Adverse Event
| Group | Value (Participants) |
|---|---|
| SC Glucagon | 16 |
| NG 1 mg | 9 |
| NG 2 mg | 15 |
| NG 3 mg | 8 |
Secondary and other outcome results(5)
Secondary outcomeMean· Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Maximum Concentration (Cmax) of Baseline-Adjusted Glucose
| Group | Value (millimole per liter (mmol/L)) | Spread |
|---|---|---|
| SC Glucagon | 5.68 | 2.57 |
| NG 1 mg | 2.41 | 1.89 |
| NG 2 mg | 3.46 | 1.44 |
| NG 3 mg | 3.11 | 2.08 |
Secondary outcomeMedian· Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
| Group | Value (hours (hr)) |
|---|---|
| SC Glucagon | 1.5 |
| NG 1 mg | 0.67 |
| NG 2 mg | 1.0 |
| NG 3 mg | 1.0 |
Secondary outcomeMean· Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Maximum Change From Baseline Concentration (Cmax) of Glucagon
| Group | Value (picograms per millilitre (pg/mL)) | Spread |
|---|---|---|
| SC Glucagon | 3930 | 2650 |
| NG 1 mg | 504 | 342 |
| NG 2 mg | 2370 | 1810 |
| NG 3 mg | 1360 | 722 |
Secondary outcomeMedian· Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
| Group | Value (hours (hr)) |
|---|---|
| SC Glucagon | 0.33 |
| NG 1 mg | 0.25 |
| NG 2 mg | 0.33 |
| NG 3 mg | 0.29 |
Secondary outcomeMean· Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon
| Group | Value (hour*picogram per millilitre (hr*pg/mL)) | Spread |
|---|---|---|
| SC Glucagon | 2390 | 1350 |
| NG 1 mg | 95.2 | 38.4 |
| NG 2 mg | 886 | 796 |
| NG 3 mg | 720 | 386 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| SC GlucagonSC glucagon injection 1 mg | – | 0 / 18 | 16 / 18 |
| NG 1 mgNG dose of 1 mg | – | 0 / 12 | 9 / 12 |
| NG 2 mgNG dose of 2 mg | – | 0 / 18 | 15 / 18 |
| NG 3 mgNG dose of 3 mg | – | 0 / 8 | 8 / 8 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 55 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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