Trial Outcomes & Findings for Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes (NCT NCT00954447)
NCT ID: NCT00954447
Last Updated: 2013-12-30
Results Overview
HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1263 participants
Primary outcome timeframe
Baseline and 24 weeks
Results posted on
2013-12-30
Participant Flow
Randomised, double-blind, placebo-controlled, parallel group study. Whilst 1263 were randomised, only 1261 were treated.
Participant milestones
| Measure |
Placebo
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Overall Study
STARTED
|
630
|
631
|
|
Overall Study
COMPLETED
|
520
|
543
|
|
Overall Study
NOT COMPLETED
|
110
|
88
|
Reasons for withdrawal
| Measure |
Placebo
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Overall Study
Adverse Event
|
33
|
25
|
|
Overall Study
Lack of Efficacy
|
17
|
3
|
|
Overall Study
Protocol Violation
|
5
|
7
|
|
Overall Study
Lost to Follow-up
|
8
|
14
|
|
Overall Study
Withdrawal by Subject
|
26
|
21
|
|
Overall Study
Other
|
21
|
18
|
Baseline Characteristics
Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=630 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=631 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Total
n=1261 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 Years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
59.7 Years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
60.0 Years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
301 Participants
n=5 Participants
|
302 Participants
n=7 Participants
|
603 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
329 Participants
n=5 Participants
|
329 Participants
n=7 Participants
|
658 Participants
n=5 Participants
|
|
Baseline HbA1c
|
8.29 Percentage
STANDARD_DEVIATION 0.85 • n=5 Participants
|
8.31 Percentage
STANDARD_DEVIATION 0.85 • n=7 Participants
|
8.30 Percentage
STANDARD_DEVIATION 0.85 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: The Full Analysis Set (FAS) with a last observation carried forward (LOCF) approach. The FAS comprises all randomised patients who were treated with at least one dose of study medication, had a baseline HbA1c measurement, and had at least one on-treatment HbA1c measurement within the first 24 weeks of double-blind treatment.
HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)
Outcome measures
| Measure |
Placebo
n=617 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=618 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Change From Baseline in HbA1c After 24 Weeks
|
0.07 Percentage
Standard Error 0.08
|
-0.58 Percentage
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 24 and 52 weeksPopulation: FAS using the non-completers considered failure (NCF) approach, in which missing data due to premature discontinuation of a patient were considered as failure.
Outcome measures
| Measure |
Placebo
n=617 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=618 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Number of Patients With HbA1c < 7.0 Percent
after 24 weeks of treatment
|
56 Participants
|
134 Participants
|
|
Number of Patients With HbA1c < 7.0 Percent
after 52 weeks of treatment
|
44 Participants
|
109 Participants
|
SECONDARY outcome
Timeframe: 24 and 52 weeksPopulation: FAS (NCF)
Outcome measures
| Measure |
Placebo
n=617 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=618 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Number of Patients Lowering HbA1c by at Least 0.5 Percent
after 24 weeks of treatment
|
137 Participants
|
333 Participants
|
|
Number of Patients Lowering HbA1c by at Least 0.5 Percent
after 52 weeks of treatment
|
104 Participants
|
231 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: FAS (LOCF)
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Outcome measures
| Measure |
Placebo
n=617 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=618 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Change From Baseline in HbA1c by Visit at Week 6
|
0.00 Percentage
Standard Error 0.05
|
-0.45 Percentage
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: FAS (LOCF)
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Outcome measures
| Measure |
Placebo
n=617 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=618 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Change From Baseline in HbA1c by Visit at Week 12
|
0.02 Percentage
Standard Error 0.07
|
-0.59 Percentage
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline and 18 weeksPopulation: FAS (LOCF)
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Outcome measures
| Measure |
Placebo
n=617 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=618 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Change From Baseline in HbA1c by Visit at Week 18
|
0.03 Percentage
Standard Error 0.08
|
-0.64 Percentage
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline and 32 weeksPopulation: FAS (LOCF)
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Outcome measures
| Measure |
Placebo
n=617 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=618 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Change From Baseline in HbA1c by Visit at Week 32
|
0.01 Percentage
Standard Error 0.08
|
-0.56 Percentage
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline and 40 weeksPopulation: FAS (LOCF)
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Outcome measures
| Measure |
Placebo
n=617 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=618 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Change From Baseline in HbA1c by Visit at Week 40
|
0.05 Percentage
Standard Error 0.08
|
-0.50 Percentage
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: FAS (LOCF)
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Outcome measures
| Measure |
Placebo
n=617 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=618 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Change From Baseline in HbA1c by Visit at Week 52
|
0.05 Percentage
Standard Error 0.08
|
-0.48 Percentage
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: FAS (LOCF), further restricted to patients with a baseline FPG measurement and at least one on-treatment FPG measurement
Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs
Outcome measures
| Measure |
Placebo
n=609 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=614 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment
|
4.52 mg/dL
Standard Error 3.94
|
-7.09 mg/dL
Standard Error 3.97
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: FAS (LOCF), further restricted to patients with a baseline FPG measurement and at least one on-treatment FPG measurement
Outcome measures
| Measure |
Placebo
n=609 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=614 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
|
0.63 mg/dL
Standard Deviation 56.44
|
-2.55 mg/dL
Standard Deviation 55.01
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, 18, 24, 32 and 40 weeksPopulation: FAS, observed cases (OC)
Outcome measures
| Measure |
Placebo
n=600 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=606 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Change From Baseline in FPG
after 6 weeks of treatment
|
2.97 mg/dL
Standard Deviation 50.89
|
-5.29 mg/dL
Standard Deviation 44.74
|
|
Change From Baseline in FPG
after 12 weeks of treatment (N=556, N=590)
|
-0.33 mg/dL
Standard Deviation 51.09
|
-7.59 mg/dL
Standard Deviation 48.50
|
|
Change From Baseline in FPG
after 18 weeks of treatment (N=533, N=567)
|
2.10 mg/dL
Standard Deviation 53.21
|
-3.30 mg/dL
Standard Deviation 55.51
|
|
Change From Baseline in FPG
after 24 weeks of treatment (N=499, N=533)
|
0.04 mg/dL
Standard Deviation 54.94
|
-7.07 mg/dL
Standard Deviation 44.70
|
|
Change From Baseline in FPG
after 32 weeks of treatment (N=436, N=491)
|
-2.67 mg/dL
Standard Deviation 52.43
|
-6.30 mg/dL
Standard Deviation 48.16
|
|
Change From Baseline in FPG
after 40 weeks of treatment (N=357, N=429)
|
-3.99 mg/dL
Standard Deviation 50.29
|
-6.50 mg/dL
Standard Deviation 50.00
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: FAS (LOCF)
Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs
Outcome measures
| Measure |
Placebo
n=617 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=618 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment
|
4.18 International units (IU)
Standard Error 0.84
|
2.60 International units (IU)
Standard Error 0.84
|
SECONDARY outcome
Timeframe: Baseline, 24 and 52 weeksPopulation: FAS (OC)
Mean Daily Glucose was calculated using the 8-point blood glucose profile
Outcome measures
| Measure |
Placebo
n=55 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=52 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment
after 24 weeks of treatment
|
0.03 mmol*hr/L
Standard Deviation 2.28
|
-0.01 mmol*hr/L
Standard Deviation 1.98
|
|
Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment
after 52 weeks of treatment (N=25, N=15)
|
0.10 mmol*hr/L
Standard Deviation 3.06
|
-0.50 mmol*hr/L
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: Baseline and 24 weeks: post-breakfast, post-lunch, post-dinnerPopulation: FAS (OC)
Outcome measures
| Measure |
Placebo
n=60 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=61 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment
post-lunch incremental glucose (N=34, N=41)
|
-17.80 mmol*hr/L
Standard Deviation 61.94
|
-11.00 mmol*hr/L
Standard Deviation 68.04
|
|
Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment
post-dinner incremental glucose (N=46, N=57)
|
-1.71 mmol*hr/L
Standard Deviation 68.15
|
-3.26 mmol*hr/L
Standard Deviation 66.51
|
|
Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment
post-breakfast incremental glucose
|
9.31 mmol*hr/L
Standard Deviation 44.02
|
-3.78 mmol*hr/L
Standard Deviation 63.63
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 and 52 weeksPopulation: FAS (NCF)
Outcome measures
| Measure |
Placebo
n=617 Participants
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=618 Participants
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Number of Patients With HbA1c < 6.5 Percent
after 24 weeks of treatment
|
10 Participants
|
50 Participants
|
|
Number of Patients With HbA1c < 6.5 Percent
after 52 weeks of treatment
|
12 Participants
|
46 Participants
|
Adverse Events
Placebo
Serious events: 83 serious events
Other events: 354 other events
Deaths: 0 deaths
Linagliptin 5 mg
Serious events: 87 serious events
Other events: 354 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=630 participants at risk
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=631 participants at risk
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.16%
1/630 • 52 weeks
|
0.32%
2/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.16%
1/630 • 52 weeks
|
0.32%
2/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Investigations
Colonoscopy
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.32%
2/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.16%
1/630 • 52 weeks
|
0.48%
3/631 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.48%
3/630 • 52 weeks
|
0.32%
2/631 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma metastatic
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.32%
2/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.16%
1/630 • 52 weeks
|
0.32%
2/631 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/630 • 52 weeks
|
0.32%
2/631 • 52 weeks
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Nervous system disorders
Cranial nerve paralysis
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Nervous system disorders
Embolic stroke
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Nervous system disorders
Ischaemic stroke
|
0.32%
2/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Nervous system disorders
Syncope
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Psychiatric disorders
Alcohol abuse
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Psychiatric disorders
Depression
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Renal and urinary disorders
Hydronephrosis
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/630 • 52 weeks
|
0.32%
2/631 • 52 weeks
|
|
Renal and urinary disorders
Renal colic
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
0.48%
3/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Renal and urinary disorders
Renal failure chronic
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Reproductive system and breast disorders
Penile pain
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Reproductive system and breast disorders
Prostatitis
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.63%
4/630 • 52 weeks
|
0.48%
3/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Fractured ischium
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Head injury
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Cardiac disorders
Acute coronary syndrome
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/630 • 52 weeks
|
0.32%
2/631 • 52 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.16%
1/630 • 52 weeks
|
0.32%
2/631 • 52 weeks
|
|
Cardiac disorders
Angina unstable
|
0.16%
1/630 • 52 weeks
|
0.48%
3/631 • 52 weeks
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.32%
2/630 • 52 weeks
|
0.48%
3/631 • 52 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.32%
2/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.48%
3/630 • 52 weeks
|
0.32%
2/631 • 52 weeks
|
|
Cardiac disorders
Coronary artery occlusion
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Cardiac disorders
Coronary artery stenosis
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Cardiac disorders
Myocardial ischaemia
|
0.32%
2/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Eye disorders
Cataract
|
0.00%
0/630 • 52 weeks
|
0.32%
2/631 • 52 weeks
|
|
Eye disorders
Diplopia
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Eye disorders
Retinal detachment
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Eye disorders
Retinopathy proliferative
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Eye disorders
Vitreous adhesions
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.16%
1/630 • 52 weeks
|
0.32%
2/631 • 52 weeks
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
General disorders
Chest pain
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
General disorders
Death
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
General disorders
Pyrexia
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
General disorders
Sudden death
|
0.00%
0/630 • 52 weeks
|
0.32%
2/631 • 52 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.16%
1/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Infections and infestations
Appendicitis perforated
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/630 • 52 weeks
|
0.32%
2/631 • 52 weeks
|
|
Infections and infestations
Bronchopneumonia
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Infections and infestations
Cellulitis
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Infections and infestations
Clostridium difficile colitis
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Infections and infestations
Erysipelas
|
0.32%
2/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Infections and infestations
Gangrene
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.32%
2/630 • 52 weeks
|
0.32%
2/631 • 52 weeks
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Infections and infestations
Influenza
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Infections and infestations
Localised infection
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Infections and infestations
Meningitis streptococcal
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Infections and infestations
Orchitis
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Infections and infestations
Pneumonia
|
0.63%
4/630 • 52 weeks
|
0.48%
3/631 • 52 weeks
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.32%
2/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Infections and infestations
Urosepsis
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.32%
2/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/630 • 52 weeks
|
0.32%
2/631 • 52 weeks
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Surgical and medical procedures
Ureteral catheterisation
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Vascular disorders
Embolism
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Vascular disorders
Hypertensive crisis
|
0.32%
2/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Vascular disorders
Hypotension
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Vascular disorders
Intermittent claudication
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Vascular disorders
Lymphoedema
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/630 • 52 weeks
|
0.16%
1/631 • 52 weeks
|
|
Vascular disorders
Venous thrombosis limb
|
0.16%
1/630 • 52 weeks
|
0.00%
0/631 • 52 weeks
|
Other adverse events
| Measure |
Placebo
n=630 participants at risk
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
Linagliptin 5 mg
n=631 participants at risk
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
30/630 • 52 weeks
|
5.2%
33/631 • 52 weeks
|
|
Infections and infestations
Influenza
|
5.2%
33/630 • 52 weeks
|
4.1%
26/631 • 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
62/630 • 52 weeks
|
11.3%
71/631 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
6.8%
43/630 • 52 weeks
|
4.8%
30/631 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
17.8%
112/630 • 52 weeks
|
14.3%
90/631 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
31.3%
197/630 • 52 weeks
|
30.3%
191/631 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
30/630 • 52 weeks
|
5.4%
34/631 • 52 weeks
|
|
Nervous system disorders
Dizziness
|
4.8%
30/630 • 52 weeks
|
5.2%
33/631 • 52 weeks
|
|
Nervous system disorders
Headache
|
4.3%
27/630 • 52 weeks
|
5.5%
35/631 • 52 weeks
|
|
Vascular disorders
Hypertension
|
5.6%
35/630 • 52 weeks
|
4.8%
30/631 • 52 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