Trial Outcomes & Findings for Study to Assess the Efficacy of Liraglutide in Patients With Type 2 Diabetes Mellitus (NCT NCT02889510)
NCT ID: NCT02889510
Last Updated: 2021-02-26
Results Overview
Changes from baseline on measurements of respiratory function defined by forced expiratory volume in 1 second (FEV1). Mean difference between 7 weeks after treatment visit and baseline visit is registered.
COMPLETED
PHASE3
76 participants
7 weeks
2021-02-26
Participant Flow
It is a cross-over study so patients are in both arms if they complete all the study. The order of the treatment received depends on the group assigned: A= treatment with subcutaneus liraglutide for 7 weeks once daily followed by treatment with subcutaneus placebo for 7 weeks B= treatment with subcutaneus placebo for 7 weeks once daily followed by treatment with subcutaneus liraglutide for 7 weeks 76 participants were enrolled in the study but only 72 started the treatment.
Participant milestones
| Measure |
Liraglutide First, Then Placebo
treatment with subcutaneus liraglutide for 7 weeks once daily followed by treatment with subcutaneus placebo for 7 weeks
|
Placebo First, Then Liraglutide
treatment with subcutaneus placebo for 7 weeks once daily followed by treatment with subcutaneus liraglutide for 7 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
37
|
|
Overall Study
COMPLETED
|
27
|
32
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two arms.
Baseline characteristics by cohort
| Measure |
All Participants
n=76 Participants
All participants in the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=76 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=76 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=76 Participants
|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 7.5 • n=76 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
73 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
Arab
|
1 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=76 Participants
|
|
Region of Enrollment
Spain
|
76 Participants
n=76 Participants
|
|
Never smokers
|
38 Participants
n=76 Participants
|
|
Body Mass Index (BMI)
Liraglutide first, then placebo
|
34.7 kg/m^2
STANDARD_DEVIATION 4.2 • n=38 Participants • Two arms.
|
|
Body Mass Index (BMI)
Placebo first,then liraglutide
|
35 kg/m^2
STANDARD_DEVIATION 4.4 • n=38 Participants • Two arms.
|
|
Systolic blood pressure
Liraglutide first, then placebo
|
146.9 mmHg
STANDARD_DEVIATION 17.3 • n=38 Participants • Two arms.
|
|
Systolic blood pressure
Placebo first,then liraglutide
|
145.2 mmHg
STANDARD_DEVIATION 19.8 • n=38 Participants • Two arms.
|
|
Fasting plasma glucose
Liraglutide first, then placebo
|
11.0 mmol/L
STANDARD_DEVIATION 3.5 • n=38 Participants • Two arms.
|
|
Fasting plasma glucose
Placebo first, then liraglutide
|
10.9 mmol/L
STANDARD_DEVIATION 4.0 • n=38 Participants • Two arms.
|
|
Glycated hemoglobin (HbA1c)
Liraglutide first, then placebo
|
67.2 mmol/mol
STANDARD_DEVIATION 12.1 • n=38 Participants • Two arms.
|
|
Glycated hemoglobin (HbA1c)
Placebo first, then liraglutide
|
63.7 mmol/mol
STANDARD_DEVIATION 10.5 • n=38 Participants • Two arms.
|
|
Forced expiratory volume in 1s (FEV1)
Liraglutide first, then placebo
|
81.1 %
STANDARD_DEVIATION 12.1 • n=38 Participants • Two arms.
|
|
Forced expiratory volume in 1s (FEV1)
Placebo first, then liraglutide
|
77.8 %
STANDARD_DEVIATION 12.1 • n=38 Participants • Two arms.
|
|
Forced vital capacity (FVC)
Liraglutide first, then placebo
|
81.9 %
STANDARD_DEVIATION 18.8 • n=38 Participants • Two arms.
|
|
Forced vital capacity (FVC)
Placebo first, then liraglutide
|
79.6 %
STANDARD_DEVIATION 12.6 • n=38 Participants • Two arms.
|
|
Maximum mid-expiratory flow (FEF25-75)
Liraglutide first, then placebo
|
79.2 %
STANDARD_DEVIATION 27.2 • n=38 Participants • Two arms.
|
|
Maximum mid-expiratory flow (FEF25-75)
Placebo first, then liraglutide
|
70.1 %
STANDARD_DEVIATION 28.9 • n=38 Participants • Two arms.
|
|
Peak expiratory flow (PEF)
Liraglutide first, then placebo
|
80.7 %
STANDARD_DEVIATION 27.2 • n=38 Participants • Two arms.
|
|
Peak expiratory flow (PEF)
Placebo first, then liraglutide
|
80.7 %
STANDARD_DEVIATION 27.8 • n=38 Participants • Two arms.
|
|
FEV1/FVC
Liraglutide first, then placebo
|
81.6 %
n=38 Participants • Two arms.
|
|
FEV1/FVC
Placebo first, then liraglutide
|
82.3 %
n=38 Participants • Two arms.
|
|
Non obstructive ventilatory defect (VD)
Liraglutide first, then placebo
|
27 %
STANDARD_DEVIATION 37.5 • n=38 Participants • Two arms.
|
|
Non obstructive ventilatory defect (VD)
Placebo first, then liraglutide
|
25 %
STANDARD_DEVIATION 38.4 • n=38 Participants • Two arms.
|
|
Surfactant A protein
Liraglutide first, then placebo
|
35.6 ng/ml
n=38 Participants • Two arms.
|
|
Surfactant A protein
Placebo first, then liraglutide
|
34.2 ng/ml
n=38 Participants • Two arms.
|
|
Surfactant D protein
Liraglutide first, then placebo
|
196.5 ng/ml
n=38 Participants • Two arms
|
|
Surfactant D protein
Placebo first, then liraglutide
|
184.2 ng/ml
n=38 Participants • Two arms
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: 59 patients ended the period of 7 weeks of liraglutide treatment (A group + B group) but only 50 have this parameter determined both at the beginning and end of the period. 61 patients ended the period of 7 weeks of placebo treatment (A group + B group) but only 50 have this parameter determined both at the beggining and at the end of the period.
Changes from baseline on measurements of respiratory function defined by forced expiratory volume in 1 second (FEV1). Mean difference between 7 weeks after treatment visit and baseline visit is registered.
Outcome measures
| Measure |
Liraglutide
n=50 Participants
7-week subcutaneous liraglutide treatment once daily
liraglutide: 7-week subcutaneous liraglutide once daily
|
Placebo
n=50 Participants
7-week subcutaneous placebo treatment once daily.
placebo: 7-week subcutaneous placebo once daily
|
|---|---|---|
|
Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second (FEV1)
|
4.1 % (FEV1)
Interval 0.0 to 8.3
|
4.3 % (FEV1)
Interval 0.1 to 8.5
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: 59 patients ended the period of 7 weeks of liraglutide treatment (A group + B group) but only 50 have this parameter determined both at the beginning and end of the period. 61 patients ended the period of 7 weeks of placebo treatment (A group + B group) but only 50 have this parameter determined both at the beginning and end of the period.
Changes from baseline on measurements of respiratory function defined by forced vital capacity (FVC). Mean difference between 7 weeks after treatment visit and baseline visit is registered.
Outcome measures
| Measure |
Liraglutide
n=50 Participants
7-week subcutaneous liraglutide treatment once daily
liraglutide: 7-week subcutaneous liraglutide once daily
|
Placebo
n=50 Participants
7-week subcutaneous placebo treatment once daily.
placebo: 7-week subcutaneous placebo once daily
|
|---|---|---|
|
Changes From Baseline on Measurements of Respiratory Function Defined by Forced Vital Capacity (FVC)
|
5.4 % (FVC)
Interval 2.1 to 8.7
|
0.2 % (FVC)
Interval -2.5 to 3.1
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: 59 patients ended the period of 7 weeks of liraglutide treatment (A group + B group) but only 48 have this parameter determined both at the beginning and end of the period. 61 patients ended the period of 7 weeks of placebo treatment (A group + B group) but only 48 have this parameter determined both at the beginning and end of the period.
Changes from baseline in serum levels of surfactant A and D protein. Values for surfactant A or D protein after 7 treatment weeks (liraglutide or placebo) are registered.
Outcome measures
| Measure |
Liraglutide
n=48 Participants
7-week subcutaneous liraglutide treatment once daily
liraglutide: 7-week subcutaneous liraglutide once daily
|
Placebo
n=48 Participants
7-week subcutaneous placebo treatment once daily.
placebo: 7-week subcutaneous placebo once daily
|
|---|---|---|
|
Changes From Baseline in Serum Levels of Surfactant A and D Protein
A protein
|
40.9 ng/ml
Interval 30.8 to 44.5
|
41.3 ng/ml
Interval 21.5 to 50.3
|
|
Changes From Baseline in Serum Levels of Surfactant A and D Protein
D protein
|
169.6 ng/ml
Interval 108.1 to 233.6
|
201.5 ng/ml
Interval 115.3 to 284.7
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: 59 patients ended the period of 7 weeks of liraglutide treatment (A group + B group) but only 46 have this parameter determined both at the beginning and end of the period. 61 patients ended the period of 7 weeks of placebo treatment (A group + B group) but only 46 have this parameter determined both at the beginning and end of the period.
Changes from baseline on measurements of respiratory function defined by Maximum mid-expiratory flow (FEF25-75). Mean difference between 7 weeks after treatment visit and baseline visit is registered.
Outcome measures
| Measure |
Liraglutide
n=46 Participants
7-week subcutaneous liraglutide treatment once daily
liraglutide: 7-week subcutaneous liraglutide once daily
|
Placebo
n=46 Participants
7-week subcutaneous placebo treatment once daily.
placebo: 7-week subcutaneous placebo once daily
|
|---|---|---|
|
Changes From Baseline on Measurements of Respiratory Function Defined by Maximum Mid-expiratory Flow (FEF25-75)
|
8.0 % (FEF25-75)
Interval -4.1 to 20.1
|
12.5 % (FEF25-75)
Interval 2.2 to 22.8
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: 59 patients ended the period of 7 weeks of liraglutide treatment (A group + B group) but only 50 have this parameter determined both at the beginning and end of the period. 61 patients ended the period of 7 weeks of placebo treatment (A group + B group) but only 50 have this parameter determined both at the beginning and end of the period.
Changes from baseline on measurements of respiratory function defined by forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC). Mean difference between 7 weeks after treatment visit and baseline visit is registered.
Outcome measures
| Measure |
Liraglutide
n=50 Participants
7-week subcutaneous liraglutide treatment once daily
liraglutide: 7-week subcutaneous liraglutide once daily
|
Placebo
n=50 Participants
7-week subcutaneous placebo treatment once daily.
placebo: 7-week subcutaneous placebo once daily
|
|---|---|---|
|
Changes From Baseline on Measurements of Respiratory Function Defined by Forced Expiratory Volume in 1 Second/Forced Vital Capacity (FEV1/FVC)
|
-2.1 % (FEV1/FVC)
Interval -5.1 to 0.9
|
1.7 % (FEV1/FVC)
Interval -0.8 to 4.2
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: 59 patients ended the period of 7 weeks of liraglutide treatment (A group + B group) but only 12 have this parameter determined both at the beginning and end of the period. 61 patients ended the period of 7 weeks of placebo treatment (A group + B group) but only 12 have this parameter determined both at the beginning and end of the period.
Changes from baseline on measurements of respiratory function defined by residual volume (RV).
Outcome measures
| Measure |
Liraglutide
n=12 Participants
7-week subcutaneous liraglutide treatment once daily
liraglutide: 7-week subcutaneous liraglutide once daily
|
Placebo
n=12 Participants
7-week subcutaneous placebo treatment once daily.
placebo: 7-week subcutaneous placebo once daily
|
|---|---|---|
|
Changes From Baseline on Measurements of Respiratory Function Defined by Residual Volume (RV)
|
3.2 % (RV)
Interval -17.5 to 24.1
|
-1.1 % (RV)
Interval -25.4 to 23.1
|
SECONDARY outcome
Timeframe: 7 weeksChanges from baseline on measurements of respiratory function defined by Total lung capacity (TLC).
Outcome measures
| Measure |
Liraglutide
n=12 Participants
7-week subcutaneous liraglutide treatment once daily
liraglutide: 7-week subcutaneous liraglutide once daily
|
Placebo
n=12 Participants
7-week subcutaneous placebo treatment once daily.
placebo: 7-week subcutaneous placebo once daily
|
|---|---|---|
|
Changes From Baseline on Measurements of Respiratory Function Defined by Total Lung Capacity (TLC)
|
-2.6 % (TLCO)
Interval -11.9 to 6.6
|
-3.1 % (TLCO)
Interval -9.5 to 3.2
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: This parameter was not determined in patients due to an error in the programm used.
Changes from baseline on measurements of respiratory function defined by Residual functional capacity (RFC) are registered. However, this parameter was not determined in patients due to an error in the programm used.
Outcome measures
Outcome data not reported
Adverse Events
Liraglutide
Placebo
Serious adverse events
| Measure |
Liraglutide
n=70 participants at risk
7-week subcutaneous liraglutide treatment once daily
liraglutide: 7-week subcutaneous liraglutide once daily
|
Placebo
n=70 participants at risk
7-week subcutaneous placebo treatment once daily.
placebo: 7-week subcutaneous placebo once daily
|
|---|---|---|
|
Vascular disorders
Ischemic stroke
|
0.00%
0/70 • 7 weeks of treatment.
|
1.4%
1/70 • Number of events 1 • 7 weeks of treatment.
|
Other adverse events
| Measure |
Liraglutide
n=70 participants at risk
7-week subcutaneous liraglutide treatment once daily
liraglutide: 7-week subcutaneous liraglutide once daily
|
Placebo
n=70 participants at risk
7-week subcutaneous placebo treatment once daily.
placebo: 7-week subcutaneous placebo once daily
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
27.1%
19/70 • Number of events 20 • 7 weeks of treatment.
|
5.7%
4/70 • Number of events 4 • 7 weeks of treatment.
|
|
Infections and infestations
Infections and infestations
|
1.4%
1/70 • Number of events 1 • 7 weeks of treatment.
|
4.3%
3/70 • Number of events 3 • 7 weeks of treatment.
|
|
Nervous system disorders
Nervous system disorders
|
2.9%
2/70 • Number of events 2 • 7 weeks of treatment.
|
2.9%
2/70 • Number of events 2 • 7 weeks of treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
1.4%
1/70 • Number of events 1 • 7 weeks of treatment.
|
2.9%
2/70 • Number of events 2 • 7 weeks of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
1.4%
1/70 • Number of events 1 • 7 weeks of treatment.
|
2.9%
2/70 • Number of events 2 • 7 weeks of treatment.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.00%
0/70 • 7 weeks of treatment.
|
4.3%
3/70 • Number of events 3 • 7 weeks of treatment.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
2.9%
2/70 • Number of events 2 • 7 weeks of treatment.
|
1.4%
1/70 • Number of events 1 • 7 weeks of treatment.
|
|
General disorders
General disorders and administration site conditions
|
2.9%
2/70 • Number of events 2 • 7 weeks of treatment.
|
0.00%
0/70 • 7 weeks of treatment.
|
|
Cardiac disorders
Cardiac disorders
|
1.4%
1/70 • Number of events 1 • 7 weeks of treatment.
|
1.4%
1/70 • Number of events 1 • 7 weeks of treatment.
|
|
Injury, poisoning and procedural complications
Traumatic injuries, poisonings and complications of therapeutic procedures
|
0.00%
0/70 • 7 weeks of treatment.
|
1.4%
1/70 • Number of events 1 • 7 weeks of treatment.
|
|
Congenital, familial and genetic disorders
Congenital, family and genetic disorders
|
0.00%
0/70 • 7 weeks of treatment.
|
1.4%
1/70 • Number of events 1 • 7 weeks of treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.00%
0/70 • 7 weeks of treatment.
|
1.4%
1/70 • Number of events 1 • 7 weeks of treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place