Trial Outcomes & Findings for Glucagon Use in Colonoscopies (NCT NCT02078726)
NCT ID: NCT02078726
Last Updated: 2025-07-03
Results Overview
ADR was defined as the percentage of participants with at least one traditional adenoma (including tubular or villous adenomas, and adenomas with high grade dysplasia or adenocarcinoma) of any size.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
During colonoscopy procedure (an average of 1139 seconds for Glucagon Arm and 1353 seconds for Placebo Arm)
Results posted on
2025-07-03
Participant Flow
Participant milestones
| Measure |
Glucagon
1 mg glucagon given during colonoscopy
Glucagon: glucagon (hormone produced by the body)
|
Placebo
1 mL normal saline
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
36
|
|
Overall Study
COMPLETED
|
64
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glucagon Use in Colonoscopies
Baseline characteristics by cohort
| Measure |
Glucagon
n=64 Participants
1 mg glucagon given during colonoscopy
Glucagon: glucagon (hormone produced by the body)
|
Placebo
n=36 Participants
1 mL normal saline
Placebo
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
30 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
16 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=99 Participants
|
36 participants
n=107 Participants
|
100 participants
n=206 Participants
|
|
Diabetes
|
18 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Tobacco use
|
21 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During colonoscopy procedure (an average of 1139 seconds for Glucagon Arm and 1353 seconds for Placebo Arm)ADR was defined as the percentage of participants with at least one traditional adenoma (including tubular or villous adenomas, and adenomas with high grade dysplasia or adenocarcinoma) of any size.
Outcome measures
| Measure |
Glucagon
n=64 Participants
1 mg glucagon given during colonoscopy
Glucagon: glucagon (hormone produced by the body)
|
Placebo
n=36 Participants
1 mL normal saline
Placebo
|
|---|---|---|
|
Adenoma Detection Rate (ADR) During Colonoscopy Procedure
|
43.75 percentage of participants
|
33.33 percentage of participants
|
Adverse Events
Glucagon
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place