Trial Outcomes & Findings for Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes (NCT NCT00395746)
NCT ID: NCT00395746
Last Updated: 2017-03-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
264 participants
Primary outcome timeframe
after 24 weeks of treatment
Results posted on
2017-03-08
Participant Flow
49 sites in Japan
Subjects included were patients with type 2 diabetes treated with diet therapy and one sulphonylurea (SU) agent (glibenclamide, gliclazide or glimepiride). Subjects continued their current SU therapy with, as a rule, no change in the dose and dosage in the study. A total of 267 subjects were randomised, 3 subjects were not exposed to study drug.
Participant milestones
| Measure |
0.6 mg + SU
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Overall Study
STARTED
|
88
|
88
|
88
|
|
Overall Study
COMPLETED
|
78
|
84
|
66
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
22
|
Reasons for withdrawal
| Measure |
0.6 mg + SU
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
2
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
17
|
|
Overall Study
Hypoglycaemia
|
2
|
1
|
0
|
|
Overall Study
Subject decision
|
0
|
0
|
1
|
|
Overall Study
Withdrawal of consent
|
0
|
0
|
1
|
|
Overall Study
Difficultulty in use of device
|
0
|
0
|
1
|
|
Overall Study
Unable to visit site on schedule
|
1
|
0
|
0
|
Baseline Characteristics
Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
0.6 mg + SU
n=88 Participants
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=88 Participants
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=88 Participants
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
Total
n=264 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
20-29
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Age, Customized
30-39
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
0 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Age, Customized
40-49
|
16 participants
n=5 Participants
|
5 participants
n=7 Participants
|
19 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Age, Customized
50-59
|
24 participants
n=5 Participants
|
27 participants
n=7 Participants
|
28 participants
n=5 Participants
|
79 participants
n=4 Participants
|
|
Age, Customized
60-69
|
30 participants
n=5 Participants
|
32 participants
n=7 Participants
|
30 participants
n=5 Participants
|
92 participants
n=4 Participants
|
|
Age, Customized
70-
|
16 participants
n=5 Participants
|
19 participants
n=7 Participants
|
11 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
58.6 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
169 Participants
n=4 Participants
|
|
BMI
|
25.25 kg/m2
STANDARD_DEVIATION 3.58 • n=5 Participants
|
24.40 kg/m2
STANDARD_DEVIATION 3.37 • n=7 Participants
|
24.94 kg/m2
STANDARD_DEVIATION 3.96 • n=5 Participants
|
24.86 kg/m2
STANDARD_DEVIATION 3.65 • n=4 Participants
|
|
Body weight
|
66.19 kg
STANDARD_DEVIATION 12.03 • n=5 Participants
|
64.53 kg
STANDARD_DEVIATION 11.95 • n=7 Participants
|
66.79 kg
STANDARD_DEVIATION 13.66 • n=5 Participants
|
65.84 kg
STANDARD_DEVIATION 12.56 • n=4 Participants
|
|
Duration of diabetes
|
9.33 years
STANDARD_DEVIATION 5.77 • n=5 Participants
|
11.61 years
STANDARD_DEVIATION 7.68 • n=7 Participants
|
10.06 years
STANDARD_DEVIATION 7.28 • n=5 Participants
|
10.33 years
STANDARD_DEVIATION 7.00 • n=4 Participants
|
|
HbA1c
|
8.48 percentage of total haemoglobin
STANDARD_DEVIATION 0.73 • n=5 Participants
|
8.26 percentage of total haemoglobin
STANDARD_DEVIATION 0.71 • n=7 Participants
|
8.44 percentage of total haemoglobin
STANDARD_DEVIATION 0.83 • n=5 Participants
|
8.39 percentage of total haemoglobin
STANDARD_DEVIATION 0.76 • n=4 Participants
|
PRIMARY outcome
Timeframe: after 24 weeks of treatmentPopulation: Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.
Outcome measures
| Measure |
0.6 mg + SU
n=86 Participants
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=87 Participants
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=88 Participants
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
|
7.02 percentage of total haemoglobin
Standard Error 0.10
|
6.75 percentage of total haemoglobin
Standard Error 0.11
|
8.02 percentage of total haemoglobin
Standard Error 0.10
|
SECONDARY outcome
Timeframe: after 52 weeks of treatmentPopulation: Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.
Outcome measures
| Measure |
0.6 mg + SU
n=86 Participants
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=87 Participants
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=88 Participants
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
|
7.42 percentage of total haemoglobin
Standard Error 0.12
|
7.06 percentage of total haemoglobin
Standard Error 0.13
|
8.39 percentage of total haemoglobin
Standard Error 0.12
|
SECONDARY outcome
Timeframe: after 24 weeks of treatmentPopulation: Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.
Outcome measures
| Measure |
0.6 mg + SU
n=85 Participants
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=86 Participants
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=87 Participants
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Fasting Plasma Glucose After 24 Weeks of Treatment
|
132.2 mg/dL
Standard Error 3.5
|
126.2 mg/dL
Standard Error 3.5
|
158.8 mg/dL
Standard Error 3.5
|
SECONDARY outcome
Timeframe: after 52 weeks of treatmentPopulation: Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.
Outcome measures
| Measure |
0.6 mg + SU
n=85 Participants
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=86 Participants
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=87 Participants
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Fasting Plasma Glucose After 52 Weeks of Treatment
|
140.3 mg/dL
Standard Error 4.0
|
134.5 mg/dL
Standard Error 4.1
|
164.6 mg/dL
Standard Error 4.0
|
SECONDARY outcome
Timeframe: after 24 weeks of treatmentPopulation: Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.
Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment
Outcome measures
| Measure |
0.6 mg + SU
n=83 Participants
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=84 Participants
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=71 Participants
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Postprandial Glucose AUC After 24 Weeks of Treatment
|
614.58 mg/dL *h
Standard Error 14.75
|
575.50 mg/dL *h
Standard Error 15.01
|
725.72 mg/dL *h
Standard Error 15.71
|
SECONDARY outcome
Timeframe: after 52 weeks of treatmentPopulation: Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.
Postprandial Glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment
Outcome measures
| Measure |
0.6 mg + SU
n=78 Participants
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=83 Participants
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=68 Participants
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Postprandial Glucose AUC After 52 Weeks of Treatment
|
648.87 mg/dL *h
Standard Error 16.09
|
589.98 mg/dL *h
Standard Error 16.17
|
717.55 mg/dL *h
Standard Error 17.08
|
SECONDARY outcome
Timeframe: after 24 weeks of treatmentPopulation: Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.
Plasma glucose (PG) profile measured after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
Outcome measures
| Measure |
0.6 mg + SU
n=80 Participants
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=82 Participants
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=80 Participants
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
|
160.20 mg/dL
Standard Error 4.44
|
150.05 mg/dL
Standard Error 4.56
|
194.50 mg/dL
Standard Error 4.61
|
SECONDARY outcome
Timeframe: after 52 weeks of treatmentPopulation: Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.
7-point plasma glucose (PG) profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
Outcome measures
| Measure |
0.6 mg + SU
n=81 Participants
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=80 Participants
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=82 Participants
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
|
171.42 mg/dL
Standard Error 5.11
|
159.58 mg/dL
Standard Error 5.30
|
205.92 mg/dL
Standard Error 5.25
|
SECONDARY outcome
Timeframe: after 24 weeks of treatmentPopulation: Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.
Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
Outcome measures
| Measure |
0.6 mg + SU
n=81 Participants
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=82 Participants
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=82 Participants
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
|
86.38 mg/dL
Standard Error 4.65
|
68.34 mg/dL
Standard Error 4.78
|
79.71 mg/dL
Standard Error 4.75
|
SECONDARY outcome
Timeframe: after 52 weeks of treatmentPopulation: Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.
Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
Outcome measures
| Measure |
0.6 mg + SU
n=82 Participants
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=80 Participants
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=85 Participants
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
|
82.28 mg/dL
Standard Error 4.81
|
76.09 mg/dL
Standard Error 5.00
|
89.39 mg/dL
Standard Error 4.86
|
SECONDARY outcome
Timeframe: after 24 weeks of treatmentPopulation: Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.
Outcome measures
| Measure |
0.6 mg + SU
n=87 Participants
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=87 Participants
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=88 Participants
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Body Weight After 24 Weeks of Treatment
|
65.77 kg
Standard Error 0.23
|
65.34 kg
Standard Error 0.24
|
64.59 kg
Standard Error 0.23
|
SECONDARY outcome
Timeframe: after 52 weeks of treatmentPopulation: Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.
Outcome measures
| Measure |
0.6 mg + SU
n=87 Participants
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=87 Participants
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=88 Participants
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Body Weight After 52 Weeks of Treatment
|
65.96 kg
Standard Error 0.26
|
65.87 kg
Standard Error 0.27
|
64.83 kg
Standard Error 0.26
|
SECONDARY outcome
Timeframe: over 52 weeks of treatmentPopulation: Full Analysis Set (FAS) consists of all subjects who received at least one dose of study drug.
Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Outcome measures
| Measure |
0.6 mg + SU
n=88 Participants
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=88 Participants
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=88 Participants
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Hypoglycaemic Episodes
Symptoms only
|
1.693 number of events per year of exposure
|
2.350 number of events per year of exposure
|
1.705 number of events per year of exposure
|
|
Hypoglycaemic Episodes
All hypoglycaemic episodes
|
3.131 number of events per year of exposure
|
3.715 number of events per year of exposure
|
2.990 number of events per year of exposure
|
|
Hypoglycaemic Episodes
Major
|
0.0000 number of events per year of exposure
|
0.0000 number of events per year of exposure
|
0.0000 number of events per year of exposure
|
|
Hypoglycaemic Episodes
Minor
|
1.438 number of events per year of exposure
|
1.365 number of events per year of exposure
|
1.285 number of events per year of exposure
|
Adverse Events
0.6 mg + SU
Serious events: 4 serious events
Other events: 68 other events
Deaths: 0 deaths
0.9 mg + SU
Serious events: 3 serious events
Other events: 68 other events
Deaths: 0 deaths
SU Mono
Serious events: 5 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.6 mg + SU
n=88 participants at risk
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=88 participants at risk
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=88 participants at risk
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Ear and labyrinth disorders
Sudden hearing loss
|
1.1%
1/88 • Number of events 1 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
1.1%
1/88 • Number of events 1 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
1.1%
1/88 • Number of events 1 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
1.1%
1/88 • Number of events 1 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Infections and infestations
Pneumonia
|
1.1%
1/88 • Number of events 1 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
1.1%
1/88 • Number of events 1 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.1%
1/88 • Number of events 1 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
1.1%
1/88 • Number of events 1 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
1.1%
1/88 • Number of events 1 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
1.1%
1/88 • Number of events 1 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic cyst
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
1.1%
1/88 • Number of events 1 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
1.1%
1/88 • Number of events 1 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
Other adverse events
| Measure |
0.6 mg + SU
n=88 participants at risk
Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
0.9 mg + SU
n=88 participants at risk
Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
SU Mono
n=88 participants at risk
Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
42.0%
37/88 • Number of events 63 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
43.2%
38/88 • Number of events 51 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
39.8%
35/88 • Number of events 61 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
7/88 • Number of events 8 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
15.9%
14/88 • Number of events 17 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
8.0%
7/88 • Number of events 10 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Gastrointestinal disorders
Constipation
|
9.1%
8/88 • Number of events 9 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
12.5%
11/88 • Number of events 12 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
4.5%
4/88 • Number of events 7 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Gastrointestinal disorders
Dental caries
|
5.7%
5/88 • Number of events 5 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
5.7%
5/88 • Number of events 5 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
1.1%
1/88 • Number of events 1 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
3/88 • Number of events 3 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
4.5%
4/88 • Number of events 4 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
9.1%
8/88 • Number of events 8 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.4%
10/88 • Number of events 10 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
8.0%
7/88 • Number of events 8 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
6.8%
6/88 • Number of events 6 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
6/88 • Number of events 6 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
3.4%
3/88 • Number of events 3 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
1.1%
1/88 • Number of events 1 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Eye disorders
Diabetic retinopathy
|
9.1%
8/88 • Number of events 8 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
12.5%
11/88 • Number of events 11 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
8.0%
7/88 • Number of events 7 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Nervous system disorders
Dizziness
|
5.7%
5/88 • Number of events 7 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
6.8%
6/88 • Number of events 7 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
2.3%
2/88 • Number of events 2 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Nervous system disorders
Headache
|
11.4%
10/88 • Number of events 11 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
4.5%
4/88 • Number of events 4 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
9.1%
8/88 • Number of events 9 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Nervous system disorders
Hypoaesthesia
|
5.7%
5/88 • Number of events 6 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
0.00%
0/88 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
5.7%
5/88 • Number of events 5 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Investigations
Alanine aminotransferase increased
|
6.8%
6/88 • Number of events 7 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
2.3%
2/88 • Number of events 2 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
1.1%
1/88 • Number of events 1 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
General disorders
Malaise
|
5.7%
5/88 • Number of events 6 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
1.1%
1/88 • Number of events 2 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
5.7%
5/88 • Number of events 6 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
10.2%
9/88 • Number of events 12 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
6.8%
6/88 • Number of events 8 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
5.7%
5/88 • Number of events 5 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Injury, poisoning and procedural complications
Fall
|
5.7%
5/88 • Number of events 5 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
2.3%
2/88 • Number of events 3 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
2.3%
2/88 • Number of events 2 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
|
Vascular disorders
Hypertension
|
5.7%
5/88 • Number of events 5 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
3.4%
3/88 • Number of events 3 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
4.5%
4/88 • Number of events 5 • Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
- Publication restrictions are in place
Restriction type: OTHER