Trial Outcomes & Findings for Effect of Liraglutide on Epicardial Fat in Subjects With Type 2 Diabetes (NCT NCT02014740)
NCT ID: NCT02014740
Last Updated: 2019-06-06
Results Overview
Echocardiographic epicardial fat thickness is an non invasive, inexpensive, reproducible and direct measure of visceral fat. In fact, epicardial fat strongly reflects the intra-abdominal and intra-myocardial fat accumulation as measured by magnetic resonance imaging procedures.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
6 months
Results posted on
2019-06-06
Participant Flow
Participant milestones
| Measure |
Liraglutide
L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued.
|
Metformin
M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl
Metformin
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
45
|
|
Overall Study
COMPLETED
|
49
|
40
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Liraglutide
L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued.
|
Metformin
M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl
Metformin
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Effect of Liraglutide on Epicardial Fat in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Liraglutide
n=55 Participants
• L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued.
|
Metformin
n=45 Participants
M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl
Metformin
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
100 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 10 • n=93 Participants
|
52 years
STANDARD_DEVIATION 10 • n=4 Participants
|
50.8 years
STANDARD_DEVIATION 10 • n=27 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=93 Participants
|
45 participants
n=4 Participants
|
100 participants
n=27 Participants
|
|
Epicardial adipose tissue Thickness (EAT)
|
9.6 mm
STANDARD_DEVIATION 2 • n=93 Participants
|
7.4 mm
STANDARD_DEVIATION 1.6 • n=4 Participants
|
8.75 mm
STANDARD_DEVIATION 1.9 • n=27 Participants
|
|
Body Mass Index (BMI)
|
37.8 kg/m2
STANDARD_DEVIATION 7 • n=93 Participants
|
32.6 kg/m2
STANDARD_DEVIATION 6 • n=4 Participants
|
35.2 kg/m2
STANDARD_DEVIATION 6 • n=27 Participants
|
|
HemoglobinA1c (HbA1c)
|
6.6 %
STANDARD_DEVIATION 0.8 • n=93 Participants
|
6.4 %
STANDARD_DEVIATION 0.6 • n=4 Participants
|
6.52 %
STANDARD_DEVIATION 0.6 • n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsEchocardiographic epicardial fat thickness is an non invasive, inexpensive, reproducible and direct measure of visceral fat. In fact, epicardial fat strongly reflects the intra-abdominal and intra-myocardial fat accumulation as measured by magnetic resonance imaging procedures.
Outcome measures
| Measure |
Liraglutide
n=55 Participants
• L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued.
|
Metformin
n=45 Participants
M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl
Metformin
|
|---|---|---|
|
Echocardiographic Epicardial Fat Thickness
Baseline
|
9.6 mm
Standard Deviation 2
|
7.4 mm
Standard Deviation 1.6
|
|
Echocardiographic Epicardial Fat Thickness
3-month
|
6.8 mm
Standard Deviation 1.5
|
7.5 mm
Standard Deviation 1.5
|
|
Echocardiographic Epicardial Fat Thickness
6-month
|
6.2 mm
Standard Deviation 1.5
|
6.9 mm
Standard Deviation 1.5
|
Adverse Events
Liraglutide
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Metformin
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Liraglutide
n=55 participants at risk
L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued.
|
Metformin
n=45 participants at risk
M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl
Metformin
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
29.1%
16/55 • 6 months
|
26.7%
12/45 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place