Trial Outcomes & Findings for Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients (NCT NCT01708902)
NCT ID: NCT01708902
Last Updated: 2015-04-24
Results Overview
The change from baseline in HbA1c after 24 weeks of treatment in main group. The mean was adjusted by baseline HbA1c and treatment group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
876 participants
Primary outcome timeframe
Baseline and week 24
Results posted on
2015-04-24
Participant Flow
After 2-weeks placebo run-in in the main group, 730 of 733 randomised patients were treated in a double-blind fashion for 24 weeks. In the additional parallel group (APG), all of 143 randomised patients with HbA1c \>=11% were treated for 24 weeks (the first 12 weeks were double-blind). There was a 1-week follow-up period after treatment.
Participant milestones
| Measure |
Main: Linagliptin 5mg QD
Main Group: Patients received linagliptin 5mg once daily (QD), administered oral as tablet.
|
Main: Metformin 500mg BID
Main Group: Patients received metformin 500mg twice daily (BID), administered oral as tablet.
|
Main: Metformin 1000mg BID
Main Group: Patients received metformin 1000mg twice daily (BID), administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 500mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
|
APG: Linagliptin 5mg QD
Additional parallel group (APG): Patients received linagliptin 5mg once daily (QD), administered oral as tablet.
(Data up to week 12)
|
APG: Linagliptin 2.5mg / Metformin 1000mg BID
Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
(Data up to week 12)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
147
|
145
|
144
|
147
|
147
|
71
|
72
|
|
Overall Study
COMPLETED
|
130
|
137
|
127
|
137
|
131
|
64
|
65
|
|
Overall Study
NOT COMPLETED
|
17
|
8
|
17
|
10
|
16
|
7
|
7
|
Reasons for withdrawal
| Measure |
Main: Linagliptin 5mg QD
Main Group: Patients received linagliptin 5mg once daily (QD), administered oral as tablet.
|
Main: Metformin 500mg BID
Main Group: Patients received metformin 500mg twice daily (BID), administered oral as tablet.
|
Main: Metformin 1000mg BID
Main Group: Patients received metformin 1000mg twice daily (BID), administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 500mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
|
APG: Linagliptin 5mg QD
Additional parallel group (APG): Patients received linagliptin 5mg once daily (QD), administered oral as tablet.
(Data up to week 12)
|
APG: Linagliptin 2.5mg / Metformin 1000mg BID
Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
(Data up to week 12)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
9
|
2
|
7
|
3
|
5
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Non compliance with protocol
|
0
|
2
|
1
|
3
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
2
|
2
|
0
|
0
|
1
|
|
Overall Study
Refused to continue trial medication
|
8
|
0
|
4
|
2
|
8
|
1
|
1
|
|
Overall Study
Other Reason
|
1
|
0
|
1
|
1
|
1
|
2
|
0
|
Baseline Characteristics
Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
Baseline characteristics by cohort
| Measure |
Main: Linagliptin 5mg QD
n=147 Participants
Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=145 Participants
Main Group: Patients received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
n=144 Participants
Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
n=147 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
n=147 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
APG: Linagliptin 5mg QD
n=71 Participants
Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.
(Data up to week 12)
|
APG: Linagliptin 2.5mg / Metformin 1000mg BID
n=72 Participants
Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
(Data up to week 12)
|
Total
n=873 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
52.1 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
51.4 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
50.7 years
STANDARD_DEVIATION 9.4 • n=21 Participants
|
49.5 years
STANDARD_DEVIATION 11.6 • n=8 Participants
|
49.9 years
STANDARD_DEVIATION 11.7 • n=8 Participants
|
51.0 years
STANDARD_DEVIATION 10.3 • n=24 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
348 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
48 Participants
n=8 Participants
|
40 Participants
n=8 Participants
|
525 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 24Population: Full analysis set (FAS): all randomised and treated patients who had a baseline and at least 1 on-treatment HbA1c value As the imputation rule for missing data the last observation carried forward (LOCF) was used.
The change from baseline in HbA1c after 24 weeks of treatment in main group. The mean was adjusted by baseline HbA1c and treatment group.
Outcome measures
| Measure |
Main: Linagliptin 5mg QD
n=141 Participants
Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=144 Participants
Main Group: Patients received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
n=133 Participants
Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
n=142 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
n=141 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
|---|---|---|---|---|---|
|
The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group
|
-1.29 percentage
Standard Error 0.08
|
-1.64 percentage
Standard Error 0.08
|
-2.07 percentage
Standard Error 0.08
|
-2.15 percentage
Standard Error 0.08
|
-2.29 percentage
Standard Error 0.08
|
PRIMARY outcome
Timeframe: Baseline and week 24Population: FAS (OC): subjects from the FAS with measured HbA1c values (observed cases \[OC\]) were considered
The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases \[OC\]) were considered. The mean was adjusted by treatment, baseline HbA1c, week and treatment\*week. The sensitivity analysis was added as the primary analysis failed with borderline results.
Outcome measures
| Measure |
Main: Linagliptin 5mg QD
n=125 Participants
Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=133 Participants
Main Group: Patients received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
n=127 Participants
Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
n=135 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
n=128 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
|---|---|---|---|---|---|
|
The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC)
|
-1.34 percentage
Standard Error 0.08
|
-1.68 percentage
Standard Error 0.08
|
-2.08 percentage
Standard Error 0.08
|
-2.16 percentage
Standard Error 0.08
|
-2.38 percentage
Standard Error 0.08
|
PRIMARY outcome
Timeframe: Baseline and week 12Population: FAS (LOCF)
The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG) The mean was adjusted by baseline HbA1c and treatment group.
Outcome measures
| Measure |
Main: Linagliptin 5mg QD
n=70 Participants
Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=68 Participants
Main Group: Patients received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
|---|---|---|---|---|---|
|
The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG
|
-3.46 percentage
Standard Error 0.22
|
-4.71 percentage
Standard Error 0.22
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 (after first drug administration)Population: FAS - non-completers were considered as nonresponders (NCF)
The occurrence of treat to target efficacy response in terms of HbA1c \< 7.0 % after 24 weeks of treatment in main group.
Outcome measures
| Measure |
Main: Linagliptin 5mg QD
n=140 Participants
Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=144 Participants
Main Group: Patients received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
n=129 Participants
Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
n=140 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
n=140 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
|---|---|---|---|---|---|
|
The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 24 Weeks of Treatment in Main Group
|
43.6 percentage of participants
Interval 35.2 to 52.2
|
50.0 percentage of participants
Interval 41.6 to 58.4
|
69.0 percentage of participants
Interval 60.3 to 76.8
|
72.1 percentage of participants
Interval 63.9 to 79.4
|
77.1 percentage of participants
Interval 69.3 to 83.8
|
SECONDARY outcome
Timeframe: Week 12 (after first drug administration)Population: FAS (NCF)
The occurrence of treat to target efficacy response in terms of HbA1c \< 7.0 % after 12 weeks of treatment in APG.
Outcome measures
| Measure |
Main: Linagliptin 5mg QD
n=70 Participants
Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=68 Participants
Main Group: Patients received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
|---|---|---|---|---|---|
|
The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 12 Weeks of Treatment in APG
|
27.1 percentage of participants
Interval 17.2 to 39.1
|
58.8 percentage of participants
Interval 46.2 to 70.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 (after first drug administration)Population: FAS (NCF)
The occurrence of treat to target efficacy response in terms of HbA1c \< 6.5% after 24 weeks of treatment in main group.
Outcome measures
| Measure |
Main: Linagliptin 5mg QD
n=141 Participants
Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=144 Participants
Main Group: Patients received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
n=133 Participants
Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
n=142 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
n=141 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
|---|---|---|---|---|---|
|
The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 24 Weeks of Treatment in Main Group
|
23.4 percentage of participants
Interval 16.7 to 31.3
|
34.7 percentage of participants
Interval 27.0 to 43.1
|
50.4 percentage of participants
Interval 41.6 to 59.2
|
56.3 percentage of participants
Interval 47.8 to 64.6
|
60.3 percentage of participants
Interval 51.7 to 68.4
|
SECONDARY outcome
Timeframe: Week 12 (after first drug administration)Population: FAS (NCF)
The occurrence of treat to target efficacy response in terms of HbA1c \< 6.5% after 12 weeks of treatment in APG.
Outcome measures
| Measure |
Main: Linagliptin 5mg QD
n=70 Participants
Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=68 Participants
Main Group: Patients received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
|---|---|---|---|---|---|
|
The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 12 Weeks of Treatment in APG
|
15.7 percentage of participants
Interval 8.1 to 26.4
|
36.8 percentage of participants
Interval 25.4 to 49.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline until week 24Population: FAS (NCF)
The occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) in main group
Outcome measures
| Measure |
Main: Linagliptin 5mg QD
n=141 Participants
Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=144 Participants
Main Group: Patients received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
n=133 Participants
Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
n=142 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
n=141 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
|---|---|---|---|---|---|
|
The Occurrence of Relative Efficacy Response in Main Group
|
73.0 percentage of participants
Interval 64.9 to 80.2
|
80.6 percentage of participants
Interval 73.1 to 86.7
|
89.5 percentage of participants
Interval 83.0 to 94.1
|
93.0 percentage of participants
Interval 87.4 to 96.6
|
89.4 percentage of participants
Interval 83.1 to 93.9
|
SECONDARY outcome
Timeframe: From baseline until week 12Population: FAS (NCF)
The Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 12 Weeks of Treatment) in APG
Outcome measures
| Measure |
Main: Linagliptin 5mg QD
n=70 Participants
Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=68 Participants
Main Group: Patients received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
|---|---|---|---|---|---|
|
The Occurrence of Relative Efficacy Response in APG
|
84.3 percentage of participants
Interval 73.6 to 91.9
|
91.2 percentage of participants
Interval 81.8 to 96.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 24Population: FAS (LOCF)
The change in fasting plasma glucose (FPG) from baseline after 24 weeks of treatment in main group. Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.
Outcome measures
| Measure |
Main: Linagliptin 5mg QD
n=140 Participants
Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=144 Participants
Main Group: Patients received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
n=133 Participants
Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
n=142 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
n=140 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
|---|---|---|---|---|---|
|
The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group
|
-15.03 mg/dL
Standard Error 2.25
|
-29.87 mg/dL
Standard Error 2.23
|
-42.07 mg/dL
Standard Error 2.31
|
-39.33 mg/dL
Standard Error 2.24
|
-47.44 mg/dL
Standard Error 2.26
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: FAS (LOCF)
The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG. Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.
Outcome measures
| Measure |
Main: Linagliptin 5mg QD
n=66 Participants
Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=67 Participants
Main Group: Patients received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
|---|---|---|---|---|---|
|
The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG
|
-56.70 mg/dL
Standard Error 6.53
|
-91.92 mg/dL
Standard Error 6.48
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline until week 24Population: FAS
The frequency of patients with use of rescue therapy during 24 week treatment period in main group. For this analysis the main group contrast 'Metformin 1000mg BID, Linagliptin 2.5mg / Metformin 1000mg BID' could not be analysed due to lack of events in the Metformin 1000mg BID group.
Outcome measures
| Measure |
Main: Linagliptin 5mg QD
n=141 Participants
Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=144 Participants
Main Group: Patients received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
n=133 Participants
Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
n=142 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
n=141 Participants
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
|---|---|---|---|---|---|
|
The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group
|
7.1 percentage of participants
Interval 3.5 to 12.7
|
2.1 percentage of participants
Interval 0.4 to 6.0
|
0.0 percentage of participants
Interval 0.0 to 2.7
|
1.4 percentage of participants
Interval 0.2 to 5.0
|
2.1 percentage of participants
Interval 0.4 to 6.1
|
SECONDARY outcome
Timeframe: From baseline until week 12Population: FAS
The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG.
Outcome measures
| Measure |
Main: Linagliptin 5mg QD
n=70 Participants
Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=68 Participants
Main Group: Patients received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
|---|---|---|---|---|---|
|
The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG
|
10.0 percentage of participants
Interval 4.1 to 19.5
|
1.5 percentage of participants
Interval 0.0 to 7.9
|
—
|
—
|
—
|
Adverse Events
Main: Linagliptin 5mg QD
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Main: Metformin 500mg BID
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Main: Metformin 1000mg BID
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
Main: Linagliptin 2.5mg / Metformin 500mg BID
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Main: Linagliptin 2.5mg / Metformin 1000mg BID
Serious events: 4 serious events
Other events: 41 other events
Deaths: 0 deaths
APG: Linagliptin 5mg QD up to Week 12
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
APG: Linagliptin 2.5mg / Metformin 1000mg BID up to Week 12
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
APG: Linagliptin 5mg After Week 12
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
APG: Linagliptin 5mg - Linagliptin 2.5mg / Met After Week 12
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
APG: Linagliptin 2.5mg / Metformin 1000mg After Week 12
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main: Linagliptin 5mg QD
n=147 participants at risk
Main Group: Patients once daily received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=145 participants at risk
Main Group: Patients twice daily received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
n=144 participants at risk
Main Group: Patients twice daily received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
n=147 participants at risk
Main Group: Patients twice daily received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
n=147 participants at risk
Main Group: Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
APG: Linagliptin 5mg QD up to Week 12
n=71 participants at risk
Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet.
(Data up to week 12)
|
APG: Linagliptin 2.5mg / Metformin 1000mg BID up to Week 12
n=72 participants at risk
Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
(Data up to week 12)
|
APG: Linagliptin 5mg After Week 12
n=33 participants at risk
Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet. Data from week 12 to week 24
|
APG: Linagliptin 5mg - Linagliptin 2.5mg / Met After Week 12
n=31 participants at risk
Additional parallel group (APG): Patients who received linagliptin 5mg QD, administered oral as tablet during the first 12 weeks and switched to linagliptin 2.5mg and metformin 1000mg (met) BID, administered oral as fixed dose combination (FDC) tablet from week 12 to week 24. Data from week 12 to week 24.
|
APG: Linagliptin 2.5mg / Metformin 1000mg After Week 12
n=65 participants at risk
Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
Data from week 12 to week 24.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.68%
1/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.69%
1/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Ear and labyrinth disorders
Otosclerosis
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.69%
1/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.68%
1/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
3.2%
1/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Infections and infestations
Paronychia
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.68%
1/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.5%
1/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.4%
1/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Infections and infestations
Septic shock
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.5%
1/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.5%
1/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.68%
1/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.68%
1/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.68%
1/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.5%
1/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.68%
1/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.4%
1/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.69%
1/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.5%
1/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Reproductive system and breast disorders
Breast disorder
|
0.68%
1/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
Other adverse events
| Measure |
Main: Linagliptin 5mg QD
n=147 participants at risk
Main Group: Patients once daily received linagliptin 5mg QD, administered oral as tablet.
|
Main: Metformin 500mg BID
n=145 participants at risk
Main Group: Patients twice daily received metformin 500mg BID, administered oral as tablet.
|
Main: Metformin 1000mg BID
n=144 participants at risk
Main Group: Patients twice daily received metformin 1000mg BID, administered oral as tablet.
|
Main: Linagliptin 2.5mg / Metformin 500mg BID
n=147 participants at risk
Main Group: Patients twice daily received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
|
Main: Linagliptin 2.5mg / Metformin 1000mg BID
n=147 participants at risk
Main Group: Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
|
APG: Linagliptin 5mg QD up to Week 12
n=71 participants at risk
Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet.
(Data up to week 12)
|
APG: Linagliptin 2.5mg / Metformin 1000mg BID up to Week 12
n=72 participants at risk
Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
(Data up to week 12)
|
APG: Linagliptin 5mg After Week 12
n=33 participants at risk
Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet. Data from week 12 to week 24
|
APG: Linagliptin 5mg - Linagliptin 2.5mg / Met After Week 12
n=31 participants at risk
Additional parallel group (APG): Patients who received linagliptin 5mg QD, administered oral as tablet during the first 12 weeks and switched to linagliptin 2.5mg and metformin 1000mg (met) BID, administered oral as fixed dose combination (FDC) tablet from week 12 to week 24. Data from week 12 to week 24.
|
APG: Linagliptin 2.5mg / Metformin 1000mg After Week 12
n=65 participants at risk
Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
Data from week 12 to week 24.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
6/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
4.1%
6/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
9.7%
14/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
8.2%
12/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
7.5%
11/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
2.8%
2/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
5.6%
4/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
3.2%
1/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.5%
1/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
2/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.4%
2/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
2.1%
3/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.4%
2/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
2.7%
4/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
5.6%
4/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
2.8%
2/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.5%
1/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.8%
7/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
2.8%
4/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
2.7%
4/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.4%
2/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
16.9%
12/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
2.8%
2/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
6.5%
2/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
3.1%
2/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.5%
11/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
9.0%
13/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
9.0%
13/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
5.4%
8/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
7.5%
11/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
5.6%
4/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
5.6%
4/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
3.0%
1/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
19.4%
6/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
6.2%
4/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
1.4%
2/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
2.1%
3/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
2.8%
4/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
3.4%
5/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
6.8%
10/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.4%
1/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
5/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
5.5%
8/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
11.1%
16/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
4.8%
7/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
9.5%
14/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
2.8%
2/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
5.6%
4/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
3.0%
1/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
3.2%
1/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.5%
1/65 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
|
Nervous system disorders
Dizziness
|
2.0%
3/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.4%
2/145 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
4.9%
7/144 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
2.0%
3/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
4.1%
6/147 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
1.4%
1/71 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
2.8%
2/72 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/33 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
6.5%
2/31 • From first drug administration (week 1) until end of treatment, up to 24 weeks
|
0.00%
0/65 • From first drug administration (week 1) until end of treatment, up to 24 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 Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER