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Trial Outcomes & Findings for Japanese P III vs Voglibose and Placebo (NCT NCT00654381)

NCT ID: NCT00654381

Last Updated: 2014-01-27

Results Overview

Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

561 participants

Primary outcome timeframe

12 weeks

Results posted on

2014-01-27

Participant Flow

Total 6 groups (including sub-groups in placebo and voglibose groups)

Placebo group has 2 sub-groups, placebo-linagliptin 5mg (from 2nd stage) and placebo-linagliptin 10mg (from 2nd stage). Both Linagliptin 5 mg and 10 mg groups don't have sub-group. Voglibose group has 2 sub-groups, voglibose-linagliptin 5mg (from 3rd stage) and voglibose-linagliptin 10mg (from 3rd stage).

Participant milestones

Participant milestones
Measure
Placebo - BI1356 (Linagliptin) 5mg - Linagliptin 5mg
Placebo in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3
Placebo - Linagliptin 5mg - Linagliptin 10mg
Placebo in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
Linagliptin 5mg - Linagliptin 5mg - Linagliptin 5mg
5 mg in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3
Linagliptin 10 mg - Linagliptin 10 mg - Linagliptin 10 mg
10 mg in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
Voglibose - Voglibose - Linagliptin 5mg
Voglibose in Stage 1 - Voglibose in Stage 2 - 5 mg in Stage 3
Voglibose - Voglibose - Linagliptin 10mg
Voglibose in Stage 1 - Voglibose in Stage 2 - 10 mg in Stage 3
1st Stage
STARTED
39
41
159
160
81
81
1st Stage
COMPLETED
36
38
156
155
79
79
1st Stage
NOT COMPLETED
3
3
3
5
2
2
2nd Stage
STARTED
36
38
156
155
79
79
2nd Stage
COMPLETED
34
38
153
151
71
76
2nd Stage
NOT COMPLETED
2
0
3
4
8
3
Extension Stage
STARTED
34
38
153
151
71
76
Extension Stage
COMPLETED
33
36
142
142
68
73
Extension Stage
NOT COMPLETED
1
2
11
9
3
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo - BI1356 (Linagliptin) 5mg - Linagliptin 5mg
Placebo in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3
Placebo - Linagliptin 5mg - Linagliptin 10mg
Placebo in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
Linagliptin 5mg - Linagliptin 5mg - Linagliptin 5mg
5 mg in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3
Linagliptin 10 mg - Linagliptin 10 mg - Linagliptin 10 mg
10 mg in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
Voglibose - Voglibose - Linagliptin 5mg
Voglibose in Stage 1 - Voglibose in Stage 2 - 5 mg in Stage 3
Voglibose - Voglibose - Linagliptin 10mg
Voglibose in Stage 1 - Voglibose in Stage 2 - 10 mg in Stage 3
1st Stage
Adverse Event
3
3
3
3
2
1
1st Stage
Withdrawal by Subject
0
0
0
1
0
1
1st Stage
Investigator's decision
0
0
0
1
0
0
2nd Stage
Adverse Event
2
0
2
3
7
2
2nd Stage
Withdrawal by Subject
0
0
0
0
1
1
2nd Stage
Investigator's decision
0
0
1
1
0
0
Extension Stage
Adverse Event
1
2
9
7
1
1
Extension Stage
Protocol Violation
0
0
0
1
0
0
Extension Stage
Lack of Efficacy
0
0
1
0
0
0
Extension Stage
Withdrawal by Subject
0
0
1
1
1
1
Extension Stage
Closure of the trial site
0
0
0
0
1
1

Baseline Characteristics

Japanese P III vs Voglibose and Placebo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=80 Participants
The patients with placebo at the start of randomised study medication
Linagliptin 5mg
n=159 Participants
The patients with linagliptin 5 mg at the start of randomised study medication
Linagliptin 10 mg
n=160 Participants
The patients with linagliptin 10 mg at the start of randomised study medication
Voglibose
n=162 Participants
The patients with voglibose at the start of randomised study medication
Total
n=561 Participants
Total of all reporting groups
Age, Continuous
59.7 years
STANDARD_DEVIATION 8.9 • n=5 Participants
60.3 years
STANDARD_DEVIATION 9.4 • n=7 Participants
61.3 years
STANDARD_DEVIATION 10 • n=5 Participants
58.5 years
STANDARD_DEVIATION 9.9 • n=4 Participants
60.0 years
STANDARD_DEVIATION 9.7 • n=21 Participants
Sex: Female, Male
Female
23 Participants
n=5 Participants
48 Participants
n=7 Participants
48 Participants
n=5 Participants
47 Participants
n=4 Participants
166 Participants
n=21 Participants
Sex: Female, Male
Male
57 Participants
n=5 Participants
111 Participants
n=7 Participants
112 Participants
n=5 Participants
115 Participants
n=4 Participants
395 Participants
n=21 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.

Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

Outcome measures

Outcome measures
Measure
Placebo
n=80 Participants
The patients with placebo at the start of randomised study medication
Linagliptin 5mg
n=159 Participants
The patients with linagliptin 5 mg at the start of randomised study medication
Linagliptin 10 mg
n=157 Participants
The patients with linagliptin 10 mg at the start of randomised study medication
Change From Baseline in HbA1c at Week 12
0.63 Percent
Standard Error 0.08
-0.24 Percent
Standard Error 0.06
-0.25 Percent
Standard Error 0.06

PRIMARY outcome

Timeframe: 26 weeks

Population: For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward.

Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

Outcome measures

Outcome measures
Measure
Placebo
n=159 Participants
The patients with placebo at the start of randomised study medication
Linagliptin 5mg
n=157 Participants
The patients with linagliptin 5 mg at the start of randomised study medication
Linagliptin 10 mg
n=162 Participants
The patients with linagliptin 10 mg at the start of randomised study medication
Change From Baseline in HbA1c at Week 26
-0.13 Percent
Standard Error 0.07
-0.19 Percent
Standard Error 0.07
0.19 Percent
Standard Error 0.07

PRIMARY outcome

Timeframe: 52 weeks

Population: The patients who received at least one dose of linagliptin 5 mg or linagliptin 10 mg during the randomised treatment period

The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks

Outcome measures

Outcome measures
Measure
Placebo
n=266 Participants
The patients with placebo at the start of randomised study medication
Linagliptin 5mg
n=274 Participants
The patients with linagliptin 5 mg at the start of randomised study medication
Linagliptin 10 mg
The patients with linagliptin 10 mg at the start of randomised study medication
Examination of Long-term Safety of Linagliptin (52-week Treatment)
Nasopharyngitis
84 participants
81 participants
—
Examination of Long-term Safety of Linagliptin (52-week Treatment)
Back pain
15 participants
21 participants
—
Examination of Long-term Safety of Linagliptin (52-week Treatment)
Constipation
12 participants
19 participants
—

SECONDARY outcome

Timeframe: 12 weeks

Population: For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.

HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12

Outcome measures

Outcome measures
Measure
Placebo
n=80 Participants
The patients with placebo at the start of randomised study medication
Linagliptin 5mg
n=159 Participants
The patients with linagliptin 5 mg at the start of randomised study medication
Linagliptin 10 mg
n=157 Participants
The patients with linagliptin 10 mg at the start of randomised study medication
Relative Efficacy Response of HbA1c at Week 12
HbA1c <7.0%
8 Participants
42 Participants
56 Participants
Relative Efficacy Response of HbA1c at Week 12
HbA1c <6.5%
0 Participants
15 Participants
18 Participants
Relative Efficacy Response of HbA1c at Week 12
HbA1c reduction from baseline ≥0.5%
7 Participants
91 Participants
94 Participants

SECONDARY outcome

Timeframe: 26 weeks

Population: For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward.

HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26

Outcome measures

Outcome measures
Measure
Placebo
n=159 Participants
The patients with placebo at the start of randomised study medication
Linagliptin 5mg
n=157 Participants
The patients with linagliptin 5 mg at the start of randomised study medication
Linagliptin 10 mg
n=162 Participants
The patients with linagliptin 10 mg at the start of randomised study medication
Relative Efficacy Response of HbA1c at Week 26
HbA1c <7.0%
48 Participants
54 Participants
36 Participants
Relative Efficacy Response of HbA1c at Week 26
HbA1c <6.5%
15 Participants
21 Participants
7 Participants
Relative Efficacy Response of HbA1c at Week 26
HbA1c reduction from baseline ≥0.5%
91 Participants
84 Participants
61 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: For the 52-week analysis, it was planed to analyse for Linagliptin 5mg and 10mg. Then the patients with placebo and voglibose were excluded in this analysis. Full analysis set for 52-week treatment period with Last Observation Carried Forward

HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52

Outcome measures

Outcome measures
Measure
Placebo
n=159 Participants
The patients with placebo at the start of randomised study medication
Linagliptin 5mg
n=157 Participants
The patients with linagliptin 5 mg at the start of randomised study medication
Linagliptin 10 mg
The patients with linagliptin 10 mg at the start of randomised study medication
Relative Efficacy Response of HbA1c at Week 52
HbA1c <7.0%
38 Participants
29 Participants
—
Relative Efficacy Response of HbA1c at Week 52
HbA1c <6.5%
6 Participants
10 Participants
—
Relative Efficacy Response of HbA1c at Week 52
HbA1c reduction from baseline ≥0.5%
62 Participants
62 Participants
—

SECONDARY outcome

Timeframe: 12 weeks

Population: For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.

Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

Outcome measures

Outcome measures
Measure
Placebo
n=80 Participants
The patients with placebo at the start of randomised study medication
Linagliptin 5mg
n=159 Participants
The patients with linagliptin 5 mg at the start of randomised study medication
Linagliptin 10 mg
n=160 Participants
The patients with linagliptin 10 mg at the start of randomised study medication
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
7.4 mg/dL
Standard Error 2.5
-12.3 mg/dL
Standard Error 1.9
-13.0 mg/dL
Standard Error 1.9

SECONDARY outcome

Timeframe: 26 weeks

Population: For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward

Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

Outcome measures

Outcome measures
Measure
Placebo
n=159 Participants
The patients with placebo at the start of randomised study medication
Linagliptin 5mg
n=160 Participants
The patients with linagliptin 5 mg at the start of randomised study medication
Linagliptin 10 mg
n=162 Participants
The patients with linagliptin 10 mg at the start of randomised study medication
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
-5.0 mg/dL
Standard Error 2.4
-7.8 mg/dL
Standard Error 2.4
2.0 mg/dL
Standard Error 2.4

SECONDARY outcome

Timeframe: 52 weeks

Population: The patients who had at least one available baseline FPG measurement under the treatment with linagliptin

Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

Outcome measures

Outcome measures
Measure
Placebo
n=159 Participants
The patients with placebo at the start of randomised study medication
Linagliptin 5mg
n=160 Participants
The patients with linagliptin 5 mg at the start of randomised study medication
Linagliptin 10 mg
The patients with linagliptin 10 mg at the start of randomised study medication
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
-3.2 mg/dL
Standard Error 2.7
-5.9 mg/dL
Standard Error 2.7
—

Adverse Events

Placebo (1st Stage)

Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths

Linagliptin 5mg (2nd-Extension Stage After Placebo)

Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths

Linagliptin 10mg (2nd-Extension Stage After Placebo)

Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths

Linagliptin 5mg (1st-2nd-Extension Stage)

Serious events: 14 serious events
Other events: 101 other events
Deaths: 0 deaths

Linagliptin 10mg (1st-2nd-Extension Stage)

Serious events: 10 serious events
Other events: 107 other events
Deaths: 0 deaths

Voglibose (1st-2nd Stage)

Serious events: 7 serious events
Other events: 83 other events
Deaths: 0 deaths

Linagliptin 5mg (Extension Stage After Voglibose)

Serious events: 3 serious events
Other events: 28 other events
Deaths: 0 deaths

Linagliptin 10mg (Extension Stage After Voglibose)

Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Placebo (1st Stage)
n=80 participants at risk
Linagliptin 5mg (2nd-Extension Stage After Placebo)
n=36 participants at risk
Linagliptin 10mg (2nd-Extension Stage After Placebo)
n=38 participants at risk
Linagliptin 5mg (1st-2nd-Extension Stage)
n=159 participants at risk
Linagliptin 10mg (1st-2nd-Extension Stage)
n=160 participants at risk
Voglibose (1st-2nd Stage)
n=162 participants at risk
Linagliptin 5mg (Extension Stage After Voglibose)
n=71 participants at risk
Linagliptin 10mg (Extension Stage After Voglibose)
n=76 participants at risk
Infections and infestations
Bronchitis
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Infections and infestations
Herpes zoster
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
1.3%
1/76 • 52 weeks
Infections and infestations
Osteomyelitis
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
1.3%
1/76 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer recurrent
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.62%
1/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Endocrine disorders
Hyperthyroidism
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Metabolism and nutrition disorders
Diabetes mellitus
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
1.4%
1/71 • 52 weeks
0.00%
0/76 • 52 weeks
Nervous system disorders
Carpal tunnel syndrome
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.62%
1/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Nervous system disorders
Cerebral infarction
0.00%
0/80 • 52 weeks
2.8%
1/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.00%
0/162 • 52 weeks
1.4%
1/71 • 52 weeks
0.00%
0/76 • 52 weeks
Nervous system disorders
Cerebral haemorrhage
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Eye disorders
Cataract
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.62%
1/162 • 52 weeks
0.00%
0/71 • 52 weeks
1.3%
1/76 • 52 weeks
Cardiac disorders
Acute coronary syndrome
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
2.6%
1/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Cardiac disorders
Acute myocardial infarction
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Cardiac disorders
Angina pectoris
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
1.2%
2/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Cardiac disorders
Angina unstable
0.00%
0/80 • 52 weeks
2.8%
1/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Cardiac disorders
Arrhythmia
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Cardiac disorders
Atrial fibrillation
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Cardiac disorders
Cardiac failure congestive
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Cardiac disorders
Coronary artery occlusion
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Vascular disorders
Hypertension
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Gastrointestinal disorders
Abdominal hernia
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Gastrointestinal disorders
Colonic polyp
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Gastrointestinal disorders
Gastric ulcer
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Gastrointestinal disorders
Haemorrhoids
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Gastrointestinal disorders
Inguinal hernia
1.2%
1/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Hepatobiliary disorders
Bile duct stone
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Hepatobiliary disorders
Cholangitis
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/80 • 52 weeks
2.8%
1/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
1.4%
1/71 • 52 weeks
0.00%
0/76 • 52 weeks
Musculoskeletal and connective tissue disorders
Limb deformity
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.62%
1/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Renal and urinary disorders
Calculus ureteric
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.62%
1/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Renal and urinary disorders
Nephrolithiasis
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Injury, poisoning and procedural complications
Airway burns
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Injury, poisoning and procedural complications
Clavicle fracture
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Injury, poisoning and procedural complications
Contusion
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Injury, poisoning and procedural complications
Fall
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.00%
0/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Injury, poisoning and procedural complications
Road traffic accident
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks

Other adverse events

Other adverse events
Measure
Placebo (1st Stage)
n=80 participants at risk
Linagliptin 5mg (2nd-Extension Stage After Placebo)
n=36 participants at risk
Linagliptin 10mg (2nd-Extension Stage After Placebo)
n=38 participants at risk
Linagliptin 5mg (1st-2nd-Extension Stage)
n=159 participants at risk
Linagliptin 10mg (1st-2nd-Extension Stage)
n=160 participants at risk
Voglibose (1st-2nd Stage)
n=162 participants at risk
Linagliptin 5mg (Extension Stage After Voglibose)
n=71 participants at risk
Linagliptin 10mg (Extension Stage After Voglibose)
n=76 participants at risk
Infections and infestations
Nasopharyngitis
12.5%
10/80 • 52 weeks
27.8%
10/36 • 52 weeks
21.1%
8/38 • 52 weeks
37.7%
60/159 • 52 weeks
35.6%
57/160 • 52 weeks
22.2%
36/162 • 52 weeks
19.7%
14/71 • 52 weeks
21.1%
16/76 • 52 weeks
Infections and infestations
Rhinitis
0.00%
0/80 • 52 weeks
5.6%
2/36 • 52 weeks
5.3%
2/38 • 52 weeks
1.3%
2/159 • 52 weeks
1.9%
3/160 • 52 weeks
1.2%
2/162 • 52 weeks
1.4%
1/71 • 52 weeks
0.00%
0/76 • 52 weeks
Infections and infestations
Bronchitis
0.00%
0/80 • 52 weeks
2.8%
1/36 • 52 weeks
5.3%
2/38 • 52 weeks
4.4%
7/159 • 52 weeks
3.8%
6/160 • 52 weeks
2.5%
4/162 • 52 weeks
1.4%
1/71 • 52 weeks
0.00%
0/76 • 52 weeks
Infections and infestations
Cystitis
1.2%
1/80 • 52 weeks
0.00%
0/36 • 52 weeks
5.3%
2/38 • 52 weeks
1.9%
3/159 • 52 weeks
0.62%
1/160 • 52 weeks
2.5%
4/162 • 52 weeks
1.4%
1/71 • 52 weeks
2.6%
2/76 • 52 weeks
Infections and infestations
Gastroenteritis
1.2%
1/80 • 52 weeks
2.8%
1/36 • 52 weeks
5.3%
2/38 • 52 weeks
2.5%
4/159 • 52 weeks
1.9%
3/160 • 52 weeks
1.2%
2/162 • 52 weeks
4.2%
3/71 • 52 weeks
1.3%
1/76 • 52 weeks
Metabolism and nutrition disorders
Diabetes mellitus
5.0%
4/80 • 52 weeks
8.3%
3/36 • 52 weeks
0.00%
0/38 • 52 weeks
4.4%
7/159 • 52 weeks
4.4%
7/160 • 52 weeks
4.3%
7/162 • 52 weeks
1.4%
1/71 • 52 weeks
5.3%
4/76 • 52 weeks
Psychiatric disorders
Depression
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
5.3%
2/38 • 52 weeks
0.00%
0/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Nervous system disorders
Dizziness
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
5.3%
2/38 • 52 weeks
1.9%
3/159 • 52 weeks
1.2%
2/160 • 52 weeks
2.5%
4/162 • 52 weeks
1.4%
1/71 • 52 weeks
0.00%
0/76 • 52 weeks
Eye disorders
Cataract
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
7.9%
3/38 • 52 weeks
1.3%
2/159 • 52 weeks
1.2%
2/160 • 52 weeks
1.2%
2/162 • 52 weeks
2.8%
2/71 • 52 weeks
1.3%
1/76 • 52 weeks
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
0.00%
0/80 • 52 weeks
2.8%
1/36 • 52 weeks
5.3%
2/38 • 52 weeks
5.7%
9/159 • 52 weeks
6.2%
10/160 • 52 weeks
1.2%
2/162 • 52 weeks
2.8%
2/71 • 52 weeks
1.3%
1/76 • 52 weeks
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/80 • 52 weeks
2.8%
1/36 • 52 weeks
5.3%
2/38 • 52 weeks
1.9%
3/159 • 52 weeks
1.9%
3/160 • 52 weeks
1.2%
2/162 • 52 weeks
2.8%
2/71 • 52 weeks
1.3%
1/76 • 52 weeks
Gastrointestinal disorders
Constipation
6.2%
5/80 • 52 weeks
0.00%
0/36 • 52 weeks
10.5%
4/38 • 52 weeks
7.5%
12/159 • 52 weeks
7.5%
12/160 • 52 weeks
3.1%
5/162 • 52 weeks
0.00%
0/71 • 52 weeks
3.9%
3/76 • 52 weeks
Gastrointestinal disorders
Dental caries
0.00%
0/80 • 52 weeks
0.00%
0/36 • 52 weeks
5.3%
2/38 • 52 weeks
4.4%
7/159 • 52 weeks
3.1%
5/160 • 52 weeks
2.5%
4/162 • 52 weeks
1.4%
1/71 • 52 weeks
0.00%
0/76 • 52 weeks
Gastrointestinal disorders
Diarrhoea
1.2%
1/80 • 52 weeks
0.00%
0/36 • 52 weeks
0.00%
0/38 • 52 weeks
6.3%
10/159 • 52 weeks
3.8%
6/160 • 52 weeks
9.3%
15/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Gastrointestinal disorders
Flatulence
1.2%
1/80 • 52 weeks
0.00%
0/36 • 52 weeks
2.6%
1/38 • 52 weeks
2.5%
4/159 • 52 weeks
4.4%
7/160 • 52 weeks
6.2%
10/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Gastrointestinal disorders
Nausea
1.2%
1/80 • 52 weeks
5.6%
2/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
0.62%
1/160 • 52 weeks
0.62%
1/162 • 52 weeks
0.00%
0/71 • 52 weeks
1.3%
1/76 • 52 weeks
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/80 • 52 weeks
5.6%
2/36 • 52 weeks
2.6%
1/38 • 52 weeks
3.8%
6/159 • 52 weeks
3.1%
5/160 • 52 weeks
1.2%
2/162 • 52 weeks
1.4%
1/71 • 52 weeks
0.00%
0/76 • 52 weeks
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/80 • 52 weeks
2.8%
1/36 • 52 weeks
5.3%
2/38 • 52 weeks
2.5%
4/159 • 52 weeks
1.9%
3/160 • 52 weeks
1.2%
2/162 • 52 weeks
0.00%
0/71 • 52 weeks
1.3%
1/76 • 52 weeks
Musculoskeletal and connective tissue disorders
Back pain
2.5%
2/80 • 52 weeks
2.8%
1/36 • 52 weeks
5.3%
2/38 • 52 weeks
6.9%
11/159 • 52 weeks
9.4%
15/160 • 52 weeks
3.7%
6/162 • 52 weeks
1.4%
1/71 • 52 weeks
5.3%
4/76 • 52 weeks
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
0.00%
0/80 • 52 weeks
5.6%
2/36 • 52 weeks
0.00%
0/38 • 52 weeks
0.63%
1/159 • 52 weeks
1.2%
2/160 • 52 weeks
0.00%
0/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks
Injury, poisoning and procedural complications
Contusion
1.2%
1/80 • 52 weeks
2.8%
1/36 • 52 weeks
5.3%
2/38 • 52 weeks
3.1%
5/159 • 52 weeks
2.5%
4/160 • 52 weeks
1.9%
3/162 • 52 weeks
0.00%
0/71 • 52 weeks
0.00%
0/76 • 52 weeks

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

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