Clinical Trial Results:
Low-dose glucagon for Prevention of Exercise-Induced Hypoglycemia in People with Type 1 Diabetes
Summary
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EudraCT number |
2021-001342-34 |
Trial protocol |
DK |
Global end of trial date |
31 Aug 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Nov 2024
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First version publication date |
27 Nov 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
78618
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Steno Diabetes Center Copenhagen
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Sponsor organisation address |
Borgmester Ib Juuls Vej 89, Herlev, Denmark, 2730
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Public contact |
Sissel Lundemose, Steno Diabetes Center Copenhagen, +45 23742764, sissel.lundemose@regionh.dk
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Scientific contact |
Sissel Lundemose, Steno Diabetes Center Copenhagen, +45 23742764, sissel.lundemose@regionh.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Aug 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Aug 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Aug 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of the study is to compare the efficacy of single-administration low-dose (150 µg) s.c. glucagon and split-administration low-dose (2 x 75 µg) s.c. glucagon to placebo for prevention of exercise-induced hypoglycemia in people with type 1 diabetes using insulin pumps and multiple daily injections (MDI).
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Protection of trial subjects |
NA
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Background therapy |
All participants used their regular treatment modality; 11 participants used insulin pump therapy and 11 participants used MDI therapy. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Aug 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 22
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Worldwide total number of subjects |
22
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EEA total number of subjects |
22
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
17
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From 65 to 84 years |
5
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were recruited from the outpatient diabetes clinic at Steno Diabetes Center Copenhagen from November 2021 to June 2023. | ||||||||||||
Pre-assignment
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Screening details |
After providing oral and written informed consent, participants completed a screening visit for assessment of the eligibility criteria. Procedures included routine blood sampling, physical examination, review of medical history and medications as well as registration of baseline characteristics. | ||||||||||||
Period 1
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Period 1 title |
Study period overall (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||||
Roles blinded |
Subject | ||||||||||||
Blinding implementation details |
The study was a single-blind study. The participants were blinded to the intervention.
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Arms
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Are arms mutually exclusive |
No
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Arm title
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150 microgram glucagon | ||||||||||||
Arm description |
Pre-exercise 150 µg s.c. glucagon and post-exercise placebo | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
GlucaGen
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Investigational medicinal product code |
SUB02347MIG
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection/infusion
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Routes of administration |
Injection
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Dosage and administration details |
150 microgram and s.c. injection
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Arm title
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75 microgram glucagon | ||||||||||||
Arm description |
Pre-exercise 75 µg s.c. glucagon and post-exercise 75 µg s.c. glucagon | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
GlucaGen
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Investigational medicinal product code |
SUB02347MIG
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection/infusion
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Routes of administration |
Injection
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Dosage and administration details |
150 microgram and s.c. injection
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Arm title
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Placebo | ||||||||||||
Arm description |
Pre-exercise placebo and post-exercise placebo | ||||||||||||
Arm type |
Placebo | ||||||||||||
Investigational medicinal product name |
Saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection
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Routes of administration |
Injection
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Dosage and administration details |
150-75 microgram of saline injected s.c.
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Baseline characteristics reporting groups
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Reporting group title |
Study period overall
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
150 microgram glucagon
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Reporting group description |
Pre-exercise 150 µg s.c. glucagon and post-exercise placebo | ||
Reporting group title |
75 microgram glucagon
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Reporting group description |
Pre-exercise 75 µg s.c. glucagon and post-exercise 75 µg s.c. glucagon | ||
Reporting group title |
Placebo
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Reporting group description |
Pre-exercise placebo and post-exercise placebo |
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End point title |
Rate of hypoglycaemia (<3.9mmol/l) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During exercise and post exercise resting phase (0-180 min)
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Statistical analysis title |
Logistic mixed effects regression model | ||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon v Placebo
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Number of subjects included in analysis |
66
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.078 | ||||||||||||
Method |
Regression, Logistic | ||||||||||||
Confidence interval |
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End point title |
Time below range (<3.9 mmol/L) | ||||||||||||||||
End point description |
Unit: percentage point
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End point type |
Secondary
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End point timeframe |
From exercise to post exercise (0-180 min)
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon v Placebo
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Number of subjects included in analysis |
66
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.359 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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End point title |
Time in range (3.9-10.0 mmol/L) | ||||||||||||||||
End point description |
Unit: percentage point
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End point type |
Secondary
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End point timeframe |
From Exercise and post exercise (0-180 min)
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon v Placebo
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Number of subjects included in analysis |
66
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.005 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.845 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v Placebo
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.028 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
Placebo v 75 microgram glucagon
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.007 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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End point title |
Time above range (>10.0 mmol/L) | ||||||||||||||||
End point description |
Unit: Percentage point
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End point type |
Secondary
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End point timeframe |
From exercise and post exercise (0-180 min)
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon v Placebo
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Number of subjects included in analysis |
66
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.007 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.91 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
Placebo v 150 microgram glucagon
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.027 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
Placebo v 75 microgram glucagon
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.009 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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End point title |
Time to hypoglycaemia | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From exercise and post exercise (0-180 min)
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Statistical analysis title |
Non parametric test | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon v Placebo
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Number of subjects included in analysis |
66
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.49 | ||||||||||||||||
Method |
Friedmanns Non parametric test | ||||||||||||||||
Confidence interval |
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End point title |
Change in plasma glucose over time | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From exercise and post exercise (o-180 min)
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon v Placebo
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Number of subjects included in analysis |
66
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.419 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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End point title |
Mean Plasma glucose | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From exercise and post exercise (0-180 min)
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon v Placebo
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Number of subjects included in analysis |
66
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.015 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Copy of Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.787 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Copy of Copy of Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v Placebo
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.076 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Copy of Copy of Copy of Generalized linear mixe... | ||||||||||||||||
Comparison groups |
Placebo v 75 microgram glucagon
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.016 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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End point title |
Hyperglycaemic events | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From exercise and post exercise (0-180 min)
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon v Placebo
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Number of subjects included in analysis |
66
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.011 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Confidence interval |
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.412 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Confidence interval |
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||
Comparison groups |
150 microgram glucagon v Placebo
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.137 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Confidence interval |
|||||||||||||
Statistical analysis title |
Generalized linear mixed model | ||||||||||||
Comparison groups |
Placebo v 75 microgram glucagon
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Number of subjects included in analysis |
44
|
||||||||||||
Analysis specification |
Pre-specified
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||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.009 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Confidence interval |
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End point title |
Nadir | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From exercise and post exercise
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon v Placebo
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Number of subjects included in analysis |
66
|
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Analysis specification |
Pre-specified
|
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.223 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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End point title |
Peak | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From exercise and post exercise (0-180 min)
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Statistical analysis title |
generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon v Placebo
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||||||||||||||||
Number of subjects included in analysis |
66
|
||||||||||||||||
Analysis specification |
Pre-specified
|
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.005 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
|||||||||||||||||
Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon
|
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Number of subjects included in analysis |
44
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||||||||||||||||
Analysis specification |
Pre-specified
|
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.511 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v Placebo
|
||||||||||||||||
Number of subjects included in analysis |
44
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.063 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
|||||||||||||||||
Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
Placebo v 75 microgram glucagon
|
||||||||||||||||
Number of subjects included in analysis |
44
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.004 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
|
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End point title |
Incemental peak | ||||||||||||||||
End point description |
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End point type |
Secondary
|
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End point timeframe |
From exercise and post exercise (0-180 min)
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon v Placebo
|
||||||||||||||||
Number of subjects included in analysis |
66
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
< 0 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
|||||||||||||||||
Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon
|
||||||||||||||||
Number of subjects included in analysis |
44
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.75 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
|||||||||||||||||
Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v Placebo
|
||||||||||||||||
Number of subjects included in analysis |
44
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.01 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
|||||||||||||||||
Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
Placebo v 75 microgram glucagon
|
||||||||||||||||
Number of subjects included in analysis |
44
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
|
|||||||||||||||||
End point title |
AUC | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From exercise and post exercise
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon v Placebo
|
||||||||||||||||
Number of subjects included in analysis |
66
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
< 0 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
|||||||||||||||||
Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v 75 microgram glucagon
|
||||||||||||||||
Number of subjects included in analysis |
44
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.215 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
|||||||||||||||||
Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
150 microgram glucagon v Placebo
|
||||||||||||||||
Number of subjects included in analysis |
44
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.061 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
|||||||||||||||||
Statistical analysis title |
Generalized linear mixed model | ||||||||||||||||
Comparison groups |
Placebo v 75 microgram glucagon
|
||||||||||||||||
Number of subjects included in analysis |
44
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From intervention (t=0) to the end of the observation period (t=180 min)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Adverse effects (nausea, headache, stomachache, palpitations and injection site pain) were scored using a 0-100 visual analog scale (VAS) just prior to the intervention (t=0), after exercise (t=60 min) and two hours later (t=180) to evaluate whether any adverse events had occurred within three/two hours after the intervention.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
None | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
150 microgram glucagon (G150)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
75*2 microgram glucagon (G75*2)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo (PBO)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |