Trial Outcomes & Findings for 30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks (NCT NCT01183013)
NCT ID: NCT01183013
Last Updated: 2014-10-20
Results Overview
HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
936 participants
Primary outcome timeframe
Baseline and 30 weeks
Results posted on
2014-10-20
Participant Flow
After Amendment #5, patients were considered COMPLETED at the end of Part A (30 weeks) or after their next Part B visit (up to 54 weeks) if already in Part B. Before Amendment #5, all patients were considered COMPLETED at the end of Part A + Part B (84 weeks).
Participant milestones
| Measure |
Pio15/Pio30
Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
|
Pio30/Pio30
Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
|
Pio45/Pio45
Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
|
Lina5/Lina5
Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
|
Lina5Pio15/Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
|
Lina5Pio30/Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
|
Lina5Pio45/Lina5Pio45
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
131
|
140
|
138
|
135
|
126
|
133
|
133
|
|
Overall Study
COMPLETED
|
86
|
101
|
97
|
105
|
90
|
88
|
96
|
|
Overall Study
NOT COMPLETED
|
45
|
39
|
41
|
30
|
36
|
45
|
37
|
Reasons for withdrawal
| Measure |
Pio15/Pio30
Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
|
Pio30/Pio30
Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
|
Pio45/Pio45
Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
|
Lina5/Lina5
Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
|
Lina5Pio15/Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
|
Lina5Pio30/Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
|
Lina5Pio45/Lina5Pio45
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
8
|
5
|
5
|
10
|
10
|
6
|
|
Overall Study
Lack of Efficacy
|
3
|
2
|
1
|
2
|
1
|
2
|
0
|
|
Overall Study
Protocol Violation
|
5
|
2
|
4
|
0
|
4
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
7
|
3
|
4
|
3
|
2
|
6
|
5
|
|
Overall Study
Withdrawal by Subject
|
9
|
13
|
10
|
8
|
7
|
9
|
10
|
|
Overall Study
Reasons other than stated above
|
15
|
11
|
17
|
12
|
12
|
15
|
13
|
Baseline Characteristics
30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks
Baseline characteristics by cohort
| Measure |
Pio15/Pio30
n=124 Participants
Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
|
Pio30/Pio30
n=134 Participants
Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
|
Pio45/Pio45
n=134 Participants
Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
|
Lina5/Lina5
n=130 Participants
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
|
Lina5Pio15/Lina5Pio30
n=120 Participants
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by a blinded trial period on linagliptin 5mg + pioglitazone 30mg FDC
|
Lina5Pio30/Lina5Pio30
n=125 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
|
Lina5Pio45/Lina5Pio45
n=126 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
|
Total
n=893 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
57.1 years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
56.4 years
STANDARD_DEVIATION 10.0 • n=8 Participants
|
60.1 years
STANDARD_DEVIATION 10.2 • n=8 Participants
|
57.1 years
STANDARD_DEVIATION 10.5 • n=24 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
57 Participants
n=8 Participants
|
410 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
64 Participants
n=8 Participants
|
69 Participants
n=8 Participants
|
483 Participants
n=24 Participants
|
|
Baseline HbA1c
|
8.33 percent
STANDARD_DEVIATION 0.93 • n=5 Participants
|
7.99 percent
STANDARD_DEVIATION 0.85 • n=7 Participants
|
8.12 percent
STANDARD_DEVIATION 0.87 • n=5 Participants
|
8.01 percent
STANDARD_DEVIATION 0.88 • n=4 Participants
|
8.13 percent
STANDARD_DEVIATION 0.94 • n=21 Participants
|
8.17 percent
STANDARD_DEVIATION 1.07 • n=8 Participants
|
8.01 percent
STANDARD_DEVIATION 0.81 • n=8 Participants
|
8.11 percent
STANDARD_DEVIATION 0.91 • n=24 Participants
|
|
Baseline fasting plasma glucose (FPG)
|
171.3 mg/dL
STANDARD_DEVIATION 39.3 • n=5 Participants
|
165.8 mg/dL
STANDARD_DEVIATION 40.0 • n=7 Participants
|
167.5 mg/dL
STANDARD_DEVIATION 37.9 • n=5 Participants
|
161.4 mg/dL
STANDARD_DEVIATION 38.1 • n=4 Participants
|
167.3 mg/dL
STANDARD_DEVIATION 39.5 • n=21 Participants
|
168.8 mg/dL
STANDARD_DEVIATION 46.8 • n=8 Participants
|
162.3 mg/dL
STANDARD_DEVIATION 36.8 • n=8 Participants
|
166.3 mg/dL
STANDARD_DEVIATION 39.9 • n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline and 30 weeksPopulation: Patients from Full Analysis Set (FAS) with last observation carried forward (LOCF) used to handle missing values at Week 30. FAS is the patient set which includes all patients who were documented to have taken at least one dose of treatment and who had a baseline HbA1c value at at least one on-treatment HbA1c.
HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.
Outcome measures
| Measure |
Pio15
n=124 Participants
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
|
Pio30
n=134 Participants
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
|
Pio45
n=134 Participants
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
|
Lina5
n=130 Participants
Participants treated with linagliptin 5mg once daily for the first 30 weeks
|
Lina5Pio15
n=120 Participants
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio30
n=125 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio45
n=126 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in HbA1c After 30 Weeks of Treatment.
|
-0.66 percent
Standard Error 0.09
|
-0.69 percent
Standard Error 0.09
|
-0.87 percent
Standard Error 0.09
|
-0.39 percent
Standard Error 0.09
|
-0.83 percent
Standard Error 0.09
|
-1.06 percent
Standard Error 0.09
|
-1.28 percent
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline and 30 weeksPopulation: FAS patients who also had baseline HbA1c\>=7%.Non-completers (patients without a value at Week 30) were considered as failures (NCF).
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Outcome measures
| Measure |
Pio15
n=121 Participants
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
|
Pio30
n=125 Participants
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
|
Pio45
n=129 Participants
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
|
Lina5
n=124 Participants
Participants treated with linagliptin 5mg once daily for the first 30 weeks
|
Lina5Pio15
n=112 Participants
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio30
n=118 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio45
n=121 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment
|
39 participants
|
55 participants
|
68 participants
|
29 participants
|
45 participants
|
61 participants
|
81 participants
|
SECONDARY outcome
Timeframe: Baseline and 30 weeksPopulation: FAS patients who also had baseline HbA1c \>=6.5%. Non-completers (patients without a value at Week 30) were considered as failures (NCF)
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Outcome measures
| Measure |
Pio15
n=124 Participants
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
|
Pio30
n=132 Participants
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
|
Pio45
n=134 Participants
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
|
Lina5
n=129 Participants
Participants treated with linagliptin 5mg once daily for the first 30 weeks
|
Lina5Pio15
n=120 Participants
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio30
n=123 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio45
n=125 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment
|
20 participants
|
28 participants
|
39 participants
|
14 participants
|
24 participants
|
38 participants
|
43 participants
|
SECONDARY outcome
Timeframe: Baseline and 30 weeksPopulation: FAS with non-completers (without a value at Week 30) considered as failure
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Outcome measures
| Measure |
Pio15
n=124 Participants
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
|
Pio30
n=134 Participants
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
|
Pio45
n=134 Participants
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
|
Lina5
n=130 Participants
Participants treated with linagliptin 5mg once daily for the first 30 weeks
|
Lina5Pio15
n=120 Participants
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio30
n=125 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio45
n=126 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)
|
79 participants
|
83 participants
|
90 participants
|
54 participants
|
79 participants
|
91 participants
|
107 participants
|
SECONDARY outcome
Timeframe: Baseline, week 6, week 12, week 18, week 24, week 30Population: FAS (observed cases)
HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment. by visit interaction.
Outcome measures
| Measure |
Pio15
n=124 Participants
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
|
Pio30
n=134 Participants
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
|
Pio45
n=134 Participants
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
|
Lina5
n=130 Participants
Participants treated with linagliptin 5mg once daily for the first 30 weeks
|
Lina5Pio15
n=120 Participants
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio30
n=125 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio45
n=126 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
HbA1c Change From Baseline by Visit Over Time
Change to week 6 (N=121,133,133,130,119,124,125)
|
-0.22 percent
Standard Error 0.06
|
-0.16 percent
Standard Error 0.06
|
-0.20 percent
Standard Error 0.06
|
-0.23 percent
Standard Error 0.06
|
-0.43 percent
Standard Error 0.06
|
-0.47 percent
Standard Error 0.06
|
-0.62 percent
Standard Error 0.06
|
|
HbA1c Change From Baseline by Visit Over Time
Change to week 12 (N=112,124,127,122,111,117,120)
|
-0.47 percent
Standard Error 0.08
|
-0.43 percent
Standard Error 0.07
|
-0.59 percent
Standard Error 0.07
|
-0.36 percent
Standard Error 0.08
|
-0.71 percent
Standard Error 0.08
|
-0.92 percent
Standard Error 0.08
|
-1.01 percent
Standard Error 0.08
|
|
HbA1c Change From Baseline by Visit Over Time
Change to week 18 (N=101,121,122,112,104,104,115)
|
-0.63 percent
Standard Error 0.09
|
-0.58 percent
Standard Error 0.08
|
-0.82 percent
Standard Error 0.08
|
-0.39 percent
Standard Error 0.08
|
-0.81 percent
Standard Error 0.09
|
-1.07 percent
Standard Error 0.09
|
-1.22 percent
Standard Error 0.09
|
|
HbA1c Change From Baseline by Visit Over Time
Change to week 24 (N=91,108,110,95,92,96,109)
|
-0.75 percent
Standard Error 0.09
|
-0.67 percent
Standard Error 0.09
|
-0.87 percent
Standard Error 0.09
|
-0.39 percent
Standard Error 0.09
|
-0.84 percent
Standard Error 0.09
|
-1.10 percent
Standard Error 0.09
|
-1.23 percent
Standard Error 0.09
|
|
HbA1c Change From Baseline by Visit Over Time
Change to week 30 (N=78,93,91,79,86,87,97)
|
-0.77 percent
Standard Error 0.09
|
-0.73 percent
Standard Error 0.08
|
-0.94 percent
Standard Error 0.09
|
-0.37 percent
Standard Error 0.09
|
-0.87 percent
Standard Error 0.09
|
-1.09 percent
Standard Error 0.09
|
-1.27 percent
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline and 30 weeksPopulation: Patients from Full Analysis Set (FAS) with a value for FPG at baseline and on-treatment. Last observation carried forward (LOCF) used to handle missing values at Week 30.
The change from baseline is the FPG after 30 weeks minus the baseline FPG.
Outcome measures
| Measure |
Pio15
n=123 Participants
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
|
Pio30
n=133 Participants
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
|
Pio45
n=134 Participants
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
|
Lina5
n=130 Participants
Participants treated with linagliptin 5mg once daily for the first 30 weeks
|
Lina5Pio15
n=119 Participants
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio30
n=123 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio45
n=125 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment
|
-15.16 mg/dL
Standard Error 3.49
|
-25.49 mg/dL
Standard Error 3.28
|
-28.69 mg/dL
Standard Error 3.29
|
-1.46 mg/dL
Standard Error 3.35
|
-18.84 mg/dL
Standard Error 3.47
|
-27.33 mg/dL
Standard Error 3.46
|
-35.19 mg/dL
Standard Error 3.40
|
SECONDARY outcome
Timeframe: Baseline, week 6, week 12, week 18, week 24, week 30Population: FAS (observed cases)
The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction
Outcome measures
| Measure |
Pio15
n=124 Participants
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
|
Pio30
n=134 Participants
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
|
Pio45
n=134 Participants
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
|
Lina5
n=130 Participants
Participants treated with linagliptin 5mg once daily for the first 30 weeks
|
Lina5Pio15
n=120 Participants
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio30
n=125 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio45
n=126 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
Change at week 6 (N=118,132,133,130,119,122,124)
|
-14.43 mg/dL
Standard Error 2.99
|
-16.38 mg/dL
Standard Error 2.80
|
-15.72 mg/dL
Standard Error 2.81
|
-4.25 mg/dL
Standard Error 2.84
|
-19.25 mg/dL
Standard Error 2.96
|
-26.89 mg/dL
Standard Error 2.94
|
-28.36 mg/dL
Standard Error 2.89
|
|
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
Change at week 12 (N=111,124,126,122,108,114,118)
|
-10.63 mg/dL
Standard Error 3.24
|
-21.36 mg/dL
Standard Error 3.04
|
-25.30 mg/dL
Standard Error 3.03
|
-7.43 mg/dL
Standard Error 3.08
|
-17.99 mg/dL
Standard Error 3.24
|
-31.25 mg/dL
Standard Error 3.19
|
-28.53 mg/dL
Standard Error 3.13
|
|
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
Change at week 18 (N=100,122,121,111,104,103,114)
|
-16.68 mg/dL
Standard Error 3.29
|
-20.69 mg/dL
Standard Error 3.02
|
-28.68 mg/dL
Standard Error 3.03
|
-7.06 mg/dL
Standard Error 3.13
|
-19.01 mg/dL
Standard Error 3.24
|
-31.22 mg/dL
Standard Error 3.25
|
-30.66 mg/dL
Standard Error 3.12
|
|
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
Change at week 24 (N=90,108,108,96,93,93,108)
|
-16.25 mg/dL
Standard Error 3.25
|
-21.57 mg/dL
Standard Error 2.99
|
-27.67 mg/dL
Standard Error 3.00
|
-4.60 mg/dL
Standard Error 3.13
|
-16.68 mg/dL
Standard Error 3.20
|
-31.48 mg/dL
Standard Error 3.20
|
-31.49 mg/dL
Standard Error 3.03
|
|
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
Change at week 30 (N=76,91,89,79,82,87,98)
|
-17.66 mg/dL
Standard Error 3.35
|
-26.09 mg/dL
Standard Error 3.08
|
-31.76 mg/dL
Standard Error 3.11
|
-0.09 mg/dL
Standard Error 3.24
|
-17.93 mg/dL
Standard Error 3.27
|
-27.11 mg/dL
Standard Error 3.22
|
-34.04 mg/dL
Standard Error 3.07
|
SECONDARY outcome
Timeframe: Baseline and 30 weeksPopulation: MTT set: This patient set includes those patients in the FAS who had a valid MTT at baseline and at least one valid on-treatment MTT. An MTT is considered valid if both an FPG and a 2-hour PPG value are available.
The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.
Outcome measures
| Measure |
Pio15
n=29 Participants
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
|
Pio30
n=34 Participants
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
|
Pio45
n=25 Participants
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
|
Lina5
n=22 Participants
Participants treated with linagliptin 5mg once daily for the first 30 weeks
|
Lina5Pio15
n=28 Participants
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio30
n=26 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio45
n=31 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)
|
-30.65 mg/dL
Standard Error 10.93
|
-83.00 mg/dL
Standard Error 9.85
|
-82.98 mg/dL
Standard Error 10.92
|
-51.61 mg/dL
Standard Error 11.67
|
-67.26 mg/dL
Standard Error 11.15
|
-87.94 mg/dL
Standard Error 11.14
|
-84.77 mg/dL
Standard Error 10.28
|
SECONDARY outcome
Timeframe: 30 weeksPopulation: FAS
Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.
Outcome measures
| Measure |
Pio15
n=124 Participants
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
|
Pio30
n=134 Participants
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
|
Pio45
n=134 Participants
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
|
Lina5
n=130 Participants
Participants treated with linagliptin 5mg once daily for the first 30 weeks
|
Lina5Pio15
n=120 Participants
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio30
n=125 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio45
n=126 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Time to First Use of Rescue Therapy
Proportion event-free
|
0.8117 Proportion of participants
50.5
|
0.8533 Proportion of participants
47.8
|
0.9051 Proportion of participants
55.3
|
0.7756 Proportion of participants
47.7
|
0.8854 Proportion of participants
61.5
|
0.9078 Proportion of participants
54.7
|
0.9548 Proportion of participants
65.7
|
|
Time to First Use of Rescue Therapy
Standard Error
|
0.0382 Proportion of participants
|
0.0330 Proportion of participants
|
0.0273 Proportion of participants
|
0.0390 Proportion of participants
|
0.0313 Proportion of participants
|
0.0279 Proportion of participants
|
0.0198 Proportion of participants
|
SECONDARY outcome
Timeframe: 30 weeksPopulation: FAS
Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.
Outcome measures
| Measure |
Pio15
n=124 Participants
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
|
Pio30
n=134 Participants
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
|
Pio45
n=134 Participants
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
|
Lina5
n=130 Participants
Participants treated with linagliptin 5mg once daily for the first 30 weeks
|
Lina5Pio15
n=120 Participants
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio30
n=125 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
|
Lina5Pio45
n=126 Participants
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Incidence of Rescue Therapy During the First 30 Weeks of Treatment
|
20 participants
|
17 participants
|
11 participants
|
26 participants
|
12 participants
|
10 participants
|
5 participants
|
Adverse Events
Pio15/Pio30
Serious events: 9 serious events
Other events: 57 other events
Deaths: 0 deaths
Pio30/Pio30
Serious events: 9 serious events
Other events: 55 other events
Deaths: 0 deaths
Pio45/Pio45
Serious events: 5 serious events
Other events: 66 other events
Deaths: 0 deaths
Lina5/Lina5
Serious events: 9 serious events
Other events: 57 other events
Deaths: 0 deaths
Lina5Pio15/Lina5Pio30
Serious events: 9 serious events
Other events: 52 other events
Deaths: 0 deaths
Lina5Pio30/Lina5Pio30
Serious events: 15 serious events
Other events: 58 other events
Deaths: 0 deaths
Lina5Pio45/Lina5Pio45
Serious events: 10 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pio15/Pio30
n=131 participants at risk
Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
|
Pio30/Pio30
n=140 participants at risk
Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
|
Pio45/Pio45
n=138 participants at risk
Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
|
Lina5/Lina5
n=135 participants at risk
Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
|
Lina5Pio15/Lina5Pio30
n=126 participants at risk
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
|
Lina5Pio30/Lina5Pio30
n=133 participants at risk
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
|
Lina5Pio45/Lina5Pio45
n=133 participants at risk
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
|
|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
|
Surgical and medical procedures
Gastric bypass
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.74%
1/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Surgical and medical procedures
Vascular graft
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.74%
1/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.74%
1/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.74%
1/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.72%
1/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.74%
1/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/131 • Up to 85 weeks
|
0.71%
1/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
1.5%
2/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.72%
1/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.79%
1/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/131 • Up to 85 weeks
|
0.71%
1/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.74%
1/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.76%
1/131 • Up to 85 weeks
|
0.71%
1/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.74%
1/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.79%
1/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.74%
1/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.79%
1/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Eye disorders
Retinal artery embolism
|
0.00%
0/131 • Up to 85 weeks
|
0.71%
1/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.79%
1/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/131 • Up to 85 weeks
|
0.71%
1/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/131 • Up to 85 weeks
|
0.71%
1/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.76%
1/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.76%
1/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
General disorders
Chest pain
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
1.5%
2/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
General disorders
Fatigue
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.72%
1/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.79%
1/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Hepatobiliary disorders
Jaundice
|
0.76%
1/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/131 • Up to 85 weeks
|
0.71%
1/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Infections and infestations
Bronchitis
|
0.76%
1/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Infections and infestations
Device related infection
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Infections and infestations
Infection
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Infections and infestations
Pneumonia
|
0.76%
1/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.79%
1/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.74%
1/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.72%
1/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.72%
1/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.79%
1/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.79%
1/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.74%
1/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.76%
1/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.74%
1/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/131 • Up to 85 weeks
|
0.71%
1/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.72%
1/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.72%
1/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hairy cell leukaemia
|
0.76%
1/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage II
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.79%
1/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.76%
1/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/131 • Up to 85 weeks
|
0.71%
1/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.76%
1/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour invasion
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.72%
1/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.79%
1/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Nervous system disorders
Encephalitis
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Nervous system disorders
Peripheral nerve palsy
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.74%
1/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.72%
1/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Psychiatric disorders
Bipolar disorder
|
0.76%
1/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.79%
1/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.74%
1/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.76%
1/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/131 • Up to 85 weeks
|
0.71%
1/140 • Up to 85 weeks
|
0.00%
0/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
0.00%
0/133 • Up to 85 weeks
|
Other adverse events
| Measure |
Pio15/Pio30
n=131 participants at risk
Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
|
Pio30/Pio30
n=140 participants at risk
Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
|
Pio45/Pio45
n=138 participants at risk
Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
|
Lina5/Lina5
n=135 participants at risk
Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
|
Lina5Pio15/Lina5Pio30
n=126 participants at risk
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
|
Lina5Pio30/Lina5Pio30
n=133 participants at risk
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
|
Lina5Pio45/Lina5Pio45
n=133 participants at risk
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
2/131 • Up to 85 weeks
|
0.00%
0/140 • Up to 85 weeks
|
3.6%
5/138 • Up to 85 weeks
|
5.2%
7/135 • Up to 85 weeks
|
7.9%
10/126 • Up to 85 weeks
|
1.5%
2/133 • Up to 85 weeks
|
2.3%
3/133 • Up to 85 weeks
|
|
General disorders
Oedema
|
3.1%
4/131 • Up to 85 weeks
|
0.71%
1/140 • Up to 85 weeks
|
5.1%
7/138 • Up to 85 weeks
|
0.00%
0/135 • Up to 85 weeks
|
0.00%
0/126 • Up to 85 weeks
|
9.0%
12/133 • Up to 85 weeks
|
3.0%
4/133 • Up to 85 weeks
|
|
General disorders
Oedema peripheral
|
9.9%
13/131 • Up to 85 weeks
|
7.9%
11/140 • Up to 85 weeks
|
8.0%
11/138 • Up to 85 weeks
|
4.4%
6/135 • Up to 85 weeks
|
6.3%
8/126 • Up to 85 weeks
|
6.8%
9/133 • Up to 85 weeks
|
11.3%
15/133 • Up to 85 weeks
|
|
Infections and infestations
Bronchitis
|
3.8%
5/131 • Up to 85 weeks
|
2.9%
4/140 • Up to 85 weeks
|
5.1%
7/138 • Up to 85 weeks
|
3.0%
4/135 • Up to 85 weeks
|
2.4%
3/126 • Up to 85 weeks
|
1.5%
2/133 • Up to 85 weeks
|
3.8%
5/133 • Up to 85 weeks
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
9/131 • Up to 85 weeks
|
7.1%
10/140 • Up to 85 weeks
|
2.9%
4/138 • Up to 85 weeks
|
7.4%
10/135 • Up to 85 weeks
|
7.1%
9/126 • Up to 85 weeks
|
6.0%
8/133 • Up to 85 weeks
|
2.3%
3/133 • Up to 85 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
2/131 • Up to 85 weeks
|
4.3%
6/140 • Up to 85 weeks
|
6.5%
9/138 • Up to 85 weeks
|
3.7%
5/135 • Up to 85 weeks
|
3.2%
4/126 • Up to 85 weeks
|
4.5%
6/133 • Up to 85 weeks
|
4.5%
6/133 • Up to 85 weeks
|
|
Infections and infestations
Urinary tract infection
|
5.3%
7/131 • Up to 85 weeks
|
5.0%
7/140 • Up to 85 weeks
|
5.8%
8/138 • Up to 85 weeks
|
5.9%
8/135 • Up to 85 weeks
|
4.0%
5/126 • Up to 85 weeks
|
5.3%
7/133 • Up to 85 weeks
|
5.3%
7/133 • Up to 85 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.9%
9/131 • Up to 85 weeks
|
7.1%
10/140 • Up to 85 weeks
|
3.6%
5/138 • Up to 85 weeks
|
10.4%
14/135 • Up to 85 weeks
|
6.3%
8/126 • Up to 85 weeks
|
6.0%
8/133 • Up to 85 weeks
|
3.8%
5/133 • Up to 85 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
3/131 • Up to 85 weeks
|
3.6%
5/140 • Up to 85 weeks
|
6.5%
9/138 • Up to 85 weeks
|
5.2%
7/135 • Up to 85 weeks
|
0.79%
1/126 • Up to 85 weeks
|
3.0%
4/133 • Up to 85 weeks
|
3.0%
4/133 • Up to 85 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.2%
12/131 • Up to 85 weeks
|
3.6%
5/140 • Up to 85 weeks
|
7.2%
10/138 • Up to 85 weeks
|
4.4%
6/135 • Up to 85 weeks
|
6.3%
8/126 • Up to 85 weeks
|
5.3%
7/133 • Up to 85 weeks
|
9.0%
12/133 • Up to 85 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
5/131 • Up to 85 weeks
|
3.6%
5/140 • Up to 85 weeks
|
3.6%
5/138 • Up to 85 weeks
|
2.2%
3/135 • Up to 85 weeks
|
5.6%
7/126 • Up to 85 weeks
|
5.3%
7/133 • Up to 85 weeks
|
4.5%
6/133 • Up to 85 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/131 • Up to 85 weeks
|
5.0%
7/140 • Up to 85 weeks
|
2.2%
3/138 • Up to 85 weeks
|
3.0%
4/135 • Up to 85 weeks
|
3.2%
4/126 • Up to 85 weeks
|
6.8%
9/133 • Up to 85 weeks
|
3.0%
4/133 • Up to 85 weeks
|
|
Nervous system disorders
Headache
|
5.3%
7/131 • Up to 85 weeks
|
5.0%
7/140 • Up to 85 weeks
|
6.5%
9/138 • Up to 85 weeks
|
4.4%
6/135 • Up to 85 weeks
|
4.0%
5/126 • Up to 85 weeks
|
3.8%
5/133 • Up to 85 weeks
|
4.5%
6/133 • Up to 85 weeks
|
|
Vascular disorders
Hypertension
|
9.2%
12/131 • Up to 85 weeks
|
2.9%
4/140 • Up to 85 weeks
|
5.1%
7/138 • Up to 85 weeks
|
6.7%
9/135 • Up to 85 weeks
|
4.8%
6/126 • Up to 85 weeks
|
3.8%
5/133 • Up to 85 weeks
|
0.75%
1/133 • Up to 85 weeks
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER