Trial Outcomes & Findings for Liraglutide in the Treatment of Type 1 Diabetes Mellitus (NCT NCT01722266)
NCT ID: NCT01722266
Last Updated: 2024-01-05
Results Overview
The primary endpoint of the study is to detect a difference from baseline in mean weekly blood glucose concentrations before and after 12 weeks of treatment in each of the Liraglutide groups.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
72 participants
Primary outcome timeframe
12 Weeks
Results posted on
2024-01-05
Participant Flow
Participant milestones
| Measure |
Placebo
Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.
|
Liraglutide 1.8mg
Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 1.2mg
Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 0.6 mg
Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
18
|
18
|
|
Overall Study
COMPLETED
|
17
|
15
|
13
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
5
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.
|
Liraglutide 1.8mg
Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 1.2mg
Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 0.6 mg
Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
|
Overall Study
Tolerated only 0.6 mg liraglutide
|
0
|
1
|
3
|
0
|
|
Overall Study
Dropped out due to Nausea
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Liraglutide in the Treatment of Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Liraglutide 0.6 mg
n=18 Participants
Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Total
n=63 Participants
Total of all reporting groups
|
Placebo
n=17 Participants
Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.
|
Liraglutide 1.8mg
n=15 Participants
Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 1.2mg
n=13 Participants
Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 4 • n=4 Participants
|
44 years
STANDARD_DEVIATION 2 • n=21 Participants
|
50 years
STANDARD_DEVIATION 3 • n=5 Participants
|
42 years
STANDARD_DEVIATION 3 • n=7 Participants
|
42 years
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=4 Participants
|
63 participants
n=21 Participants
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Age of Type 1 Diabetes Diagnosis
|
19 years
STANDARD_DEVIATION 3 • n=4 Participants
|
20 years
STANDARD_DEVIATION 1 • n=21 Participants
|
19 years
STANDARD_DEVIATION 3 • n=5 Participants
|
21 years
STANDARD_DEVIATION 3 • n=7 Participants
|
21 years
STANDARD_DEVIATION 3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksThe primary endpoint of the study is to detect a difference from baseline in mean weekly blood glucose concentrations before and after 12 weeks of treatment in each of the Liraglutide groups.
Outcome measures
| Measure |
Placebo
n=17 Participants
Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.
|
Liraglutide 1.8mg
n=15 Participants
Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 1.2mg
n=13 Participants
Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 0.6 mg
n=18 Participants
Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
|---|---|---|---|---|
|
Change in Mean Weekly Glucose Concentrations
|
1 mg/dl
Standard Error 0
|
-10 mg/dl
Standard Error 1
|
-10 mg/dl
Standard Error 2
|
-0.3 mg/dl
Standard Error 2
|
SECONDARY outcome
Timeframe: 12 WeeksChange from baseline (week 0) in HbA1c at 12 weeks after treatment
Outcome measures
| Measure |
Placebo
n=17 Participants
Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.
|
Liraglutide 1.8mg
n=15 Participants
Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 1.2mg
n=13 Participants
Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 0.6 mg
n=18 Participants
Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
|---|---|---|---|---|
|
Change in HbA1c
|
-0.30 Percent of Hemoglobin (%)
Standard Error 0.15
|
-0.42 Percent of Hemoglobin (%)
Standard Error 0.15
|
-0.78 Percent of Hemoglobin (%)
Standard Error 0.15
|
-0.26 Percent of Hemoglobin (%)
Standard Error 0.17
|
SECONDARY outcome
Timeframe: 12 weeksChange in Body weight in Kg from baseline after 12 weeks of treatment
Outcome measures
| Measure |
Placebo
n=17 Participants
Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.
|
Liraglutide 1.8mg
n=15 Participants
Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 1.2mg
n=13 Participants
Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 0.6 mg
n=18 Participants
Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
|---|---|---|---|---|
|
Change in Body Weight From Baseline
|
-0.3 Kg
Standard Error 0.5
|
-4.8 Kg
Standard Error 0.7
|
-5.0 Kg
Standard Error 1.2
|
-2.7 Kg
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 12 weeksTotal daily insulin dose = Basal insulin dose plus bolus insulin dose. Change from baseline in Total daily insulin dose at 12 weeks from treatment.
Outcome measures
| Measure |
Placebo
n=17 Participants
Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.
|
Liraglutide 1.8mg
n=15 Participants
Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 1.2mg
n=13 Participants
Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 0.6 mg
n=18 Participants
Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
|---|---|---|---|---|
|
Change in Total Insulin Dose From Baseline
|
-3.4 Units of insulin
Standard Error 0.7
|
-10 Units of insulin
Standard Error 0.5
|
-12.1 Units of insulin
Standard Error 0.7
|
-2.8 Units of insulin
Standard Error 0.7
|
SECONDARY outcome
Timeframe: 12 weeksChange in the Area Under Curve (AUC0h-5h) of glucose concentration measured following meal challenge of up to 5hrs performed at baseline (week 0) at 12 weeks following treatment.
Outcome measures
| Measure |
Placebo
n=17 Participants
Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.
|
Liraglutide 1.8mg
n=15 Participants
Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 1.2mg
n=13 Participants
Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 0.6 mg
n=18 Participants
Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
|---|---|---|---|---|
|
Change in the Area Under Curve (AUC) of Glucose Following the Meal
|
0.04 g * 5 h * dL^-1
Standard Error 0
|
-0.55 g * 5 h * dL^-1
Standard Error 10
|
-0.55 g * 5 h * dL^-1
Standard Error 10
|
-0.01 g * 5 h * dL^-1
Standard Error 0.11
|
SECONDARY outcome
Timeframe: 12 weeksChange from baseline (0 week) in Daily Carbohydrate intake (in grams) at 12 weeks after treatment.
Outcome measures
| Measure |
Placebo
n=17 Participants
Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.
|
Liraglutide 1.8mg
n=15 Participants
Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 1.2mg
n=13 Participants
Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 0.6 mg
n=18 Participants
Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
|---|---|---|---|---|
|
Change in Carbohydrate Intake
|
-13.4 grams
Standard Error 2.6
|
-46.4 grams
Standard Error 1.6
|
-47.6 grams
Standard Error 2.6
|
-23.7 grams
Standard Error 2.5
|
SECONDARY outcome
Timeframe: 12 weekschange from baseline (week 0) in glucagon concentrations following 12 weeks of treatment
Outcome measures
| Measure |
Placebo
n=17 Participants
Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.
|
Liraglutide 1.8mg
n=15 Participants
Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 1.2mg
n=13 Participants
Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 0.6 mg
n=18 Participants
Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
|---|---|---|---|---|
|
Change in Glucagon Concentrations
|
5 ng/L
Standard Error 3
|
9 ng/L
Standard Error 6
|
-6 ng/L
Standard Error 9
|
7 ng/L
Standard Error 4
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Liraglutide 1.8mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Liraglutide 1.2mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Liraglutide 0.6 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=17 participants at risk
Daily Injection
Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards.
|
Liraglutide 1.8mg
n=15 participants at risk
Daily Injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 1.2mg
n=13 participants at risk
Daily injections
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
Liraglutide 0.6 mg
n=18 participants at risk
Daily injection
Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Transient Nausea
|
17.6%
3/17 • Number of events 3 • 12 weeks.
|
60.0%
9/15 • Number of events 9 • 12 weeks.
|
76.9%
10/13 • Number of events 10 • 12 weeks.
|
61.1%
11/18 • Number of events 11 • 12 weeks.
|
Additional Information
Nitesh D Kuhadiya,MD,MPH ;Co-Investigator;Assistant Professor of Medicine, Section of Endocrinology
University at Buffalo
Phone: 716-626-7998
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place