Trial Outcomes & Findings for Comprehensive Add on Study in Japan (NCT NCT01204294)
NCT ID: NCT01204294
Last Updated: 2014-03-28
Results Overview
The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
574 participants
Primary outcome timeframe
The first drug administration through 7 days after the last drug administration, up to 382 days
Results posted on
2014-03-28
Participant Flow
A total of 618 patients were enrolled in the trial at 43 trial sites, and 37 patients were withdrawn from the trial because of screening failure. 581 patients were entered into the 2-week placebo run-in period, and 7 patients were withdrawn. 574 patients completed the 2-week placebo run-in period and took linagliptin 5 mg or metformin.
Participant milestones
| Measure |
Bigu+Lina
biguanide plus linagliptin
|
Glin+Lina
glinide plus linagliptin
|
Glit+Lina
glitazone plus linagliptin
|
SU+Lina
sulfonylurea plus linagliptin
|
A-GI+Lina
alpha-glucosidase inhibitor plus linagliptin
|
SU+Met
sulfonylurea plus metformin
|
A-GI+Met
alpha-glucosidase inhibitor plus metformin
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
82
|
66
|
74
|
143
|
85
|
63
|
61
|
|
Overall Study
COMPLETED
|
79
|
58
|
69
|
132
|
83
|
58
|
59
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
5
|
11
|
2
|
5
|
2
|
Reasons for withdrawal
| Measure |
Bigu+Lina
biguanide plus linagliptin
|
Glin+Lina
glinide plus linagliptin
|
Glit+Lina
glitazone plus linagliptin
|
SU+Lina
sulfonylurea plus linagliptin
|
A-GI+Lina
alpha-glucosidase inhibitor plus linagliptin
|
SU+Met
sulfonylurea plus metformin
|
A-GI+Met
alpha-glucosidase inhibitor plus metformin
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
6
|
0
|
7
|
1
|
4
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
2
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
2
|
1
|
1
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Other (house moving)
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Comprehensive Add on Study in Japan
Baseline characteristics by cohort
| Measure |
Bigu+Lina
n=82 Participants
biguanide plus linagliptin
|
Glin+Lina
n=66 Participants
glinide plus linagliptin
|
Glit+Lina
n=74 Participants
glitazone plus linagliptin
|
SU+Lina
n=143 Participants
sulfonylurea plus linagliptin
|
A-GI+Lina
n=85 Participants
alpha-glucosidase inhibitor plus linagliptin
|
SU+Met
n=63 Participants
sulfonylurea plus metformin
|
A-GI+Met
n=61 Participants
alpha-glucosidase inhibitor plus metformin
|
Total
n=574 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
|
58.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
62.0 years
STANDARD_DEVIATION 10.4 • n=21 Participants
|
61.2 years
STANDARD_DEVIATION 10.6 • n=10 Participants
|
59.3 years
STANDARD_DEVIATION 10.3 • n=115 Participants
|
60.9 years
STANDARD_DEVIATION 10.2 • n=6 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
173 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
44 Participants
n=10 Participants
|
42 Participants
n=115 Participants
|
401 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: The first drug administration through 7 days after the last drug administration, up to 382 daysPopulation: The treated set (TS) comprised all patients who received at least one dose of randomised study medication in the 52-week treatment period
The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events
Outcome measures
| Measure |
Bigu+Lina
n=82 Participants
biguanide plus linagliptin
|
Glin+Lina
n=66 Participants
glinide plus linagliptin
|
Glit+Lina
n=74 Participants
glitazone plus linagliptin
|
SU+Lina
n=143 Participants
sulfonylurea plus linagliptin
|
A-GI+Lina
n=85 Participants
alpha-glucosidase inhibitor plus linagliptin
|
SU+Met
n=63 Participants
sulfonylurea plus metformin
|
A-GI+Met
n=61 Participants
alpha-glucosidase inhibitor plus metformin
|
|---|---|---|---|---|---|---|---|
|
Incidence of Adverse Events (AEs)
Patients with any AE
|
69 Patients
|
55 Patients
|
62 Patients
|
114 Patients
|
71 Patients
|
44 Patients
|
52 Patients
|
|
Incidence of Adverse Events (AEs)
Patients with severe AE
|
1 Patients
|
1 Patients
|
0 Patients
|
2 Patients
|
1 Patients
|
1 Patients
|
0 Patients
|
|
Incidence of Adverse Events (AEs)
Patients with AEs leading to discontinuation
|
2 Patients
|
5 Patients
|
0 Patients
|
8 Patients
|
1 Patients
|
4 Patients
|
0 Patients
|
|
Incidence of Adverse Events (AEs)
Patients with Hypoglycaemic events
|
1 Patients
|
0 Patients
|
2 Patients
|
21 Patients
|
2 Patients
|
10 Patients
|
2 Patients
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: The full analysis set (FAS) comprised all treated patients who had baseline HbA1c measurement and at least one on-treatment HbA1c measurement available
The change from baseline in HbA1c after 52 weeks of treatment. When the HbA1c after 52 weeks treatment was missing, the value from the measurements at the closest preceding visit replaced the missing value.
Outcome measures
| Measure |
Bigu+Lina
n=82 Participants
biguanide plus linagliptin
|
Glin+Lina
n=63 Participants
glinide plus linagliptin
|
Glit+Lina
n=73 Participants
glitazone plus linagliptin
|
SU+Lina
n=140 Participants
sulfonylurea plus linagliptin
|
A-GI+Lina
n=85 Participants
alpha-glucosidase inhibitor plus linagliptin
|
SU+Met
n=62 Participants
sulfonylurea plus metformin
|
A-GI+Met
n=61 Participants
alpha-glucosidase inhibitor plus metformin
|
|---|---|---|---|---|---|---|---|
|
Glycosylated Haemoglobin A1c (HbA1c)
At 52 weeks
|
7.10 Percentage
Standard Deviation 0.82
|
7.19 Percentage
Standard Deviation 0.75
|
7.07 Percentage
Standard Deviation 0.74
|
7.42 Percentage
Standard Deviation 0.91
|
6.96 Percentage
Standard Deviation 0.75
|
7.19 Percentage
Standard Deviation 0.72
|
6.98 Percentage
Standard Deviation 0.75
|
|
Glycosylated Haemoglobin A1c (HbA1c)
Baseline
|
7.98 Percentage
Standard Deviation 0.75
|
7.92 Percentage
Standard Deviation 0.82
|
7.86 Percentage
Standard Deviation 0.83
|
8.12 Percentage
Standard Deviation 0.78
|
7.87 Percentage
Standard Deviation 0.75
|
8.01 Percentage
Standard Deviation 0.64
|
8.07 Percentage
Standard Deviation 1.04
|
|
Glycosylated Haemoglobin A1c (HbA1c)
Change from baseline to 52 weeks
|
-0.88 Percentage
Standard Deviation 0.64
|
-0.73 Percentage
Standard Deviation 0.65
|
-0.79 Percentage
Standard Deviation 0.50
|
-0.70 Percentage
Standard Deviation 0.70
|
-0.91 Percentage
Standard Deviation 0.61
|
-0.82 Percentage
Standard Deviation 0.78
|
-1.09 Percentage
Standard Deviation 0.87
|
Adverse Events
Bigu+Lina
Serious events: 8 serious events
Other events: 55 other events
Deaths: 0 deaths
Glin+Lina
Serious events: 5 serious events
Other events: 41 other events
Deaths: 0 deaths
Glit+Lina
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
SU+Lina
Serious events: 7 serious events
Other events: 83 other events
Deaths: 0 deaths
A-GI+Lina
Serious events: 7 serious events
Other events: 54 other events
Deaths: 0 deaths
SU+Met
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
A-GI+Met
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bigu+Lina
n=82 participants at risk
biguanide plus linagliptin
|
Glin+Lina
n=66 participants at risk
glinide plus linagliptin
|
Glit+Lina
n=74 participants at risk
glitazone plus linagliptin
|
SU+Lina
n=143 participants at risk
sulfonylurea plus linagliptin
|
A-GI+Lina
n=85 participants at risk
alpha-glucosidase inhibitor plus linagliptin
|
SU+Met
n=63 participants at risk
sulfonylurea plus metformin
|
A-GI+Met
n=61 participants at risk
alpha-glucosidase inhibitor plus metformin
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Infectious peritonitis
|
1.2%
1/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.2%
1/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Infections and infestations
Pyelonephritis acute
|
1.2%
1/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.5%
1/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.2%
1/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer recurrent
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.70%
1/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.70%
1/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.70%
1/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Nervous system disorders
Cerebral infarction
|
1.2%
1/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Nervous system disorders
Neuropathy peripheral
|
1.2%
1/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.2%
1/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.70%
1/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Eye disorders
Cataract
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.70%
1/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.70%
1/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.4%
1/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
1/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.2%
1/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.5%
1/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.5%
1/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.2%
1/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.2%
1/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.70%
1/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.5%
1/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.4%
1/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
2.4%
2/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.4%
1/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.5%
1/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.2%
1/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
1.2%
1/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.70%
1/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.70%
1/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
Other adverse events
| Measure |
Bigu+Lina
n=82 participants at risk
biguanide plus linagliptin
|
Glin+Lina
n=66 participants at risk
glinide plus linagliptin
|
Glit+Lina
n=74 participants at risk
glitazone plus linagliptin
|
SU+Lina
n=143 participants at risk
sulfonylurea plus linagliptin
|
A-GI+Lina
n=85 participants at risk
alpha-glucosidase inhibitor plus linagliptin
|
SU+Met
n=63 participants at risk
sulfonylurea plus metformin
|
A-GI+Met
n=61 participants at risk
alpha-glucosidase inhibitor plus metformin
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
36.6%
30/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
45.5%
30/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
33.8%
25/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
31.5%
45/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
41.2%
35/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
20.6%
13/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
44.3%
27/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Infections and infestations
Bronchitis
|
11.0%
9/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.5%
1/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.4%
1/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
3.5%
5/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
3.5%
3/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
4.9%
3/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Infections and infestations
Pharyngitis
|
6.1%
5/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
7.6%
5/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
4.1%
3/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
3.5%
5/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
2.4%
2/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
3.2%
2/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
5/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
3.0%
2/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.4%
1/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
2.4%
2/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Infections and infestations
Gastroenteritis
|
2.4%
2/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.5%
1/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
2.7%
2/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
2.8%
4/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
4.7%
4/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
6.3%
4/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
2.7%
2/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
14.0%
20/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.2%
1/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
15.9%
10/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
3.3%
2/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
4.9%
4/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
3.0%
2/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
8.1%
6/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
2.8%
4/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
3.5%
3/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
9.8%
6/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
1/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.4%
1/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.2%
1/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
6.3%
4/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Gastrointestinal disorders
Constipation
|
3.7%
3/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
4.5%
3/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
2.7%
2/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
2.8%
4/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
5.9%
5/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
6.3%
4/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
2/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
3.0%
2/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.4%
1/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.70%
1/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
3.5%
3/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
6.3%
4/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Injury, poisoning and procedural complications
Contusion
|
4.9%
4/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
3.0%
2/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.4%
1/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
7.0%
10/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
2.4%
2/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
8.2%
5/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
4/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
4.5%
3/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.4%
1/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
7.0%
10/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
3.5%
3/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
6.6%
4/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
5/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
5.4%
4/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.70%
1/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
3.5%
3/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Gastrointestinal disorders
Periodontal disease
|
1.2%
1/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.5%
1/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
5.6%
8/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
3.5%
3/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
0.00%
0/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
4/82 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.5%
1/66 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.4%
1/74 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
2.8%
4/143 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
5.9%
5/85 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/63 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
1.6%
1/61 • The first drug administration through 7 days after the last drug administration, up to 382 days
|
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
- Publication restrictions are in place