Trial Outcomes & Findings for Liraglutide in Adolescents With Type 1 Diabetes (NCT NCT02516657)

Last Updated: 2025-04-20

Results Overview

The primary outcome is to determine whether liraglutide decreases mean weekly blood glucose (mean mg/dL glucose as measured by continuous glucose monitor readings) in adolescents with Type 1 diabetes

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

5 participants

Primary outcome timeframe

Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

Results posted on

2025-04-20

Participant Flow

Recruited from medical clinic

Participant milestones

Participant milestones
Measure	Liraglutide 0.6 mg Liraglutide 0.6 mg daily injection x 7 days Liraglutide: Liraglutide 0.6 mg
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Liraglutide in Adolescents With Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liraglutide 0.6 mg n=5 Participants Liraglutide 0.6 mg daily injection x 7 days Liraglutide: Liraglutide 0.6 mg
Age, Categorical <=18 years	5 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	5 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	5 Participants n=99 Participants
Hemoglobin A1c	8.52 Percent of glycosylated HemoglobinA STANDARD_DEVIATION 0.64 • n=99 Participants
Total Daily insulin dose	73.74 Units per day STANDARD_DEVIATION 10.09 • n=99 Participants

PRIMARY outcome

Timeframe: Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

Population: Data for mean weekly blood glucose was only collected for 4 of the 5 subjects enrolled in the study. 1 subject had missing CGM data

The primary outcome is to determine whether liraglutide decreases mean weekly blood glucose (mean mg/dL glucose as measured by continuous glucose monitor readings) in adolescents with Type 1 diabetes

Outcome measures

Outcome measures
Measure	Liraglutide 0.6 mg n=4 Participants Liraglutide 0.6 mg daily injection x 7 days Liraglutide: Liraglutide 0.6 mg	Liraglutide Treatment U/kg/day during liraglutide treatment
Mean Weekly Blood Glucose Visit 1, before liraglutide	187 mg/dL Standard Deviation 35	—
Mean Weekly Blood Glucose Visit 2, after liraglutide	178 mg/dL Standard Deviation 42	—

SECONDARY outcome

Timeframe: Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

Population: Unable to determine mean U/kg/day for one of the subjects due to missing data

mean U/kg/day over 7 days

Outcome measures

Outcome measures
Measure	Liraglutide 0.6 mg n=4 Participants Liraglutide 0.6 mg daily injection x 7 days Liraglutide: Liraglutide 0.6 mg	Liraglutide Treatment n=4 Participants U/kg/day during liraglutide treatment
Total Daily Insulin Dose	0.97 U/kg/day Standard Deviation 0.18	0.67 U/kg/day Standard Deviation 0.14

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

Population: Unable to determine mean U/kg/day for one of the subjects due to missing data

Determine whether liraglutide increases episodes of blood sugar \<70 mg/dL as measured by glucometer and CGM

Outcome measures

Outcome measures
Measure	Liraglutide 0.6 mg n=4 Participants Liraglutide 0.6 mg daily injection x 7 days Liraglutide: Liraglutide 0.6 mg	Liraglutide Treatment n=4 Participants U/kg/day during liraglutide treatment
Blood Sugar < 70 mg/dL	5.5 episodes Standard Deviation 7.7	3.3 episodes Standard Deviation 3.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;

Determine amylase levels before and during liraglutide treatment

Outcome measures

Outcome measures
Measure	Liraglutide 0.6 mg n=5 Participants Liraglutide 0.6 mg daily injection x 7 days Liraglutide: Liraglutide 0.6 mg	Liraglutide Treatment n=5 Participants U/kg/day during liraglutide treatment
Serum Amylase Level	36 U/L Standard Deviation 15	33 U/L Standard Deviation 11

Adverse Events

Liraglutide 0.6 mg

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

Lucy D. Mastrandrea

Jacobs School of Medicine and Biomedical Sciences, Department of Pediatrics

Phone: 716-323-0170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place