Trial Outcomes & Findings for Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM (NCT NCT00736099)
NCT ID: NCT00736099
Last Updated: 2014-06-27
Results Overview
This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2122 participants
Primary outcome timeframe
78 weeks
Results posted on
2014-06-27
Participant Flow
Participant milestones
| Measure |
Old Lina
Patients pre-treated with linagliptin (BI 1356)
|
New Lina
Patients pre-treated with placebo
|
|---|---|---|
|
Overall Study
STARTED
|
1532
|
589
|
|
Overall Study
COMPLETED
|
1349
|
531
|
|
Overall Study
NOT COMPLETED
|
183
|
58
|
Reasons for withdrawal
| Measure |
Old Lina
Patients pre-treated with linagliptin (BI 1356)
|
New Lina
Patients pre-treated with placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
61
|
18
|
|
Overall Study
Protocol Violation
|
10
|
4
|
|
Overall Study
Lost to Follow-up
|
12
|
5
|
|
Overall Study
Withdrawal by Subject
|
42
|
13
|
|
Overall Study
Lack of Efficacy
|
15
|
8
|
|
Overall Study
Other reason
|
43
|
10
|
Baseline Characteristics
Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
Baseline characteristics by cohort
| Measure |
Old Lina
n=1532 Participants
Patients pre-treated with linagliptin
|
New Lina
n=589 Participants
Patients pre-treated with placebo
|
Total
n=2121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
57.5 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
743 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
1022 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
789 Participants
n=5 Participants
|
310 Participants
n=7 Participants
|
1099 Participants
n=5 Participants
|
|
Body mass index (BMI) continuous
|
28.86 kg/m^2
STANDARD_DEVIATION 4.82 • n=5 Participants
|
29.18 kg/m^2
STANDARD_DEVIATION 4.91 • n=7 Participants
|
28.95 kg/m^2
STANDARD_DEVIATION 4.85 • n=5 Participants
|
|
Baseline weight
|
78.7 kg
STANDARD_DEVIATION 16.9 • n=5 Participants
|
80.1 kg
STANDARD_DEVIATION 16.9 • n=7 Participants
|
79.1 kg
STANDARD_DEVIATION 16.9 • n=5 Participants
|
|
Baseline Glycosylated haemoglobin (HbA1c) at baseline
|
7.38 percent
STANDARD_DEVIATION 0.90 • n=5 Participants
|
7.87 percent
STANDARD_DEVIATION 1.04 • n=7 Participants
|
7.51 percent
STANDARD_DEVIATION 0.97 • n=5 Participants
|
|
Fasting plasma glucose (FPG) at baseline
|
151.59 mg/dL
STANDARD_DEVIATION 35.32 • n=5 Participants
|
164.31 mg/dL
STANDARD_DEVIATION 37.36 • n=7 Participants
|
155.12 mg/dL
STANDARD_DEVIATION 36.34 • n=5 Participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.
This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
Outcome measures
| Measure |
Old Lina
n=1532 Participants
Patients pre-treated with linagliptin
|
New Lina
n=589 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Frequency of Patients With Adverse Events (AEs)
Patients with any AEs
|
1253 Participants
|
465 Participants
|
|
Frequency of Patients With Adverse Events (AEs)
Patients with severe AEs
|
57 Participants
|
23 Participants
|
|
Frequency of Patients With Adverse Events (AEs)
Patients with withdrawal due to AEs (from AE page)
|
57 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.
Outcome measures
| Measure |
Old Lina
n=1532 Participants
Patients pre-treated with linagliptin
|
New Lina
n=589 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events
|
209 Participants
|
86 Participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.
As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis'').
Outcome measures
| Measure |
Old Lina
n=1532 Participants
Patients pre-treated with linagliptin
|
New Lina
n=589 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)
Hepatic AEs
|
21 Participants
|
5 Participants
|
|
Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)
Renal AEs
|
20 Participants
|
10 Participants
|
|
Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)
Hypersensitivity reactions
|
7 Participants
|
3 Participants
|
|
Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)
Severe cutaneous adverse reactions
|
0 Participants
|
0 Participants
|
|
Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)
Pancreatitis
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set: all screened patients who were documented to have taken at least 1 dose of study drug
Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)
Outcome measures
| Measure |
Old Lina
n=1532 Participants
Patients pre-treated with linagliptin
|
New Lina
n=589 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events
|
82 participants
|
37 participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.
Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)
Outcome measures
| Measure |
Old Lina
n=1532 Participants
Patients pre-treated with linagliptin
|
New Lina
n=589 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Vital Signs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Eosinophils
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.
Outcome measures
| Measure |
Old Lina
n=1512 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Haematology: Eosinophils
|
91 participants
|
33 participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Haemoglobin
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients.
Outcome measures
| Measure |
Old Lina
n=1513 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Haematology: Haemoglobin
|
63 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Haematocrit
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.
Outcome measures
| Measure |
Old Lina
n=1513 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Haematology: Haematocrit
|
48 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Red blood cell count
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 \* 10\^12/L.
Outcome measures
| Measure |
Old Lina
n=1513 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Haematology: Red Blood Cell Count
|
31 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for White blood cell count
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 \* 10\^9/L (decrease) or a value greater than 20.1 \* 10\^9/L (increase).
Outcome measures
| Measure |
Old Lina
n=1513 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Haematology: White Blood Cell Count
Decrease
|
30 Participants
|
10 Participants
|
|
Number of Patients With Abnormalities in Haematology: White Blood Cell Count
Increase
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Platelets
For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 \* 10\^9/L (decrease) or a value greater than or equal to 700 \* 10\^9/L (increase).
Outcome measures
| Measure |
Old Lina
n=1513 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Haematology: Platelets
Decrease
|
5 Participants
|
0 Participants
|
|
Number of Patients With Abnormalities in Haematology: Platelets
Increase
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Potassium
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase).
Outcome measures
| Measure |
Old Lina
n=1514 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Potassium
Decrease
|
3 participants
|
0 participants
|
|
Number of Patients With Abnormalities in Clinical Chemistry: Potassium
Increase
|
135 participants
|
50 participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Uric acid
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients.
Outcome measures
| Measure |
Old Lina
n=1514 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid
|
124 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Triglycerides
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.
Outcome measures
| Measure |
Old Lina
n=1514 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides
|
329 Participants
|
101 Participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Amylase
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN).
Outcome measures
| Measure |
Old Lina
n=1514 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Amylase
|
92 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for GGT
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Outcome measures
| Measure |
Old Lina
n=1514 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)
|
54 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Creatinine
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.
Outcome measures
| Measure |
Old Lina
n=1514 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Creatinine
|
52 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Creatinine kinase
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Outcome measures
| Measure |
Old Lina
n=1514 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase
|
49 participants
|
6 participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Phosphate
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase).
Outcome measures
| Measure |
Old Lina
n=1514 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Phosphate
Decrease
|
11 participants
|
8 participants
|
|
Number of Patients With Abnormalities in Clinical Chemistry: Phosphate
Increase
|
38 participants
|
11 participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Calcium
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase).
Outcome measures
| Measure |
Old Lina
n=1514 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Calcium
Decrease
|
36 participants
|
12 participants
|
|
Number of Patients With Abnormalities in Clinical Chemistry: Calcium
Increase
|
4 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Sodium
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase).
Outcome measures
| Measure |
Old Lina
n=1514 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Sodium
Decrease
|
16 participants
|
3 participants
|
|
Number of Patients With Abnormalities in Clinical Chemistry: Sodium
Increase
|
13 participants
|
8 participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for ALT
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Outcome measures
| Measure |
Old Lina
n=1511 Participants
Patients pre-treated with linagliptin
|
New Lina
n=578 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)
|
22 participants
|
5 participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for AST
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Outcome measures
| Measure |
Old Lina
n=1511 Participants
Patients pre-treated with linagliptin
|
New Lina
n=578 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)
|
19 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Glucose
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.
Outcome measures
| Measure |
Old Lina
n=1514 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Glucose
|
7 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Bilirubin
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.
Outcome measures
| Measure |
Old Lina
n=1514 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin
|
6 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for AP
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.
Outcome measures
| Measure |
Old Lina
n=1514 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)
|
7 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Albumin
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.
Outcome measures
| Measure |
Old Lina
n=1514 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Albumin
|
3 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for LDH
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Outcome measures
| Measure |
Old Lina
n=1511 Participants
Patients pre-treated with linagliptin
|
New Lina
n=577 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for Cholesterol
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.
Outcome measures
| Measure |
Old Lina
n=1514 Participants
Patients pre-treated with linagliptin
|
New Lina
n=579 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline and week 6Population: Treated Set with values for HbA1c at baseline and week 6. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=1401 Participants
Patients pre-treated with linagliptin
|
New Lina
n=530 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Change in HbA1c From Baseline to Week 6
|
-0.02 percent
Standard Deviation 0.47
|
-0.46 percent
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: Baseline and week 18Population: Treated Set with values for HbA1c at baseline and week 18. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=1302 Participants
Patients pre-treated with linagliptin
|
New Lina
n=510 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Change in HbA1c From Baseline to Week 18
|
0.03 percent
Standard Deviation 0.63
|
-0.63 percent
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Baseline and week 30Population: Treated Set with values for HbA1c at baseline and week 30. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=1183 Participants
Patients pre-treated with linagliptin
|
New Lina
n=469 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Change in HbA1c From Baseline to Week 30
|
0.06 percent
Standard Deviation 0.71
|
-0.60 percent
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Baseline and week 42Population: Treated Set with values for HbA1c at baseline and week 42. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=1091 Participants
Patients pre-treated with linagliptin
|
New Lina
n=440 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Change in HbA1c From Baseline to Week 42
|
0.13 percent
Standard Deviation 0.65
|
-0.53 percent
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Baseline and week 54Population: Treated Set with values for HbA1c at baseline and week 54. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=1008 Participants
Patients pre-treated with linagliptin
|
New Lina
n=417 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Change in HbA1c From Baseline to Week 54
|
0.19 percent
Standard Deviation 0.70
|
-0.45 percent
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Baseline and week 66Population: Treated Set with values for HbA1c at baseline and week 66. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=949 Participants
Patients pre-treated with linagliptin
|
New Lina
n=399 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Change in HbA1c From Baseline to Week 66
|
0.14 percent
Standard Deviation 0.73
|
-0.44 percent
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Baseline and week 78Population: Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=904 Participants
Patients pre-treated with linagliptin
|
New Lina
n=373 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Change in HbA1c From Baseline to Week 78
|
0.12 percent
Standard Deviation 0.76
|
-0.49 percent
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=904 Participants
Patients pre-treated with linagliptin
|
New Lina
n=373 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With HbA1c<7.0% Over Time
|
382 participants
|
172 participants
|
SECONDARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=904 Participants
Patients pre-treated with linagliptin
|
New Lina
n=373 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With HbA1c<6.5% Over Time
|
139 participants
|
74 participants
|
SECONDARY outcome
Timeframe: 78 weeksPopulation: Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=904 Participants
Patients pre-treated with linagliptin
|
New Lina
n=373 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Number of Patients With Lowered HbA1c by at Least 0.5% Over Time
|
155 participants
|
175 participants
|
SECONDARY outcome
Timeframe: Baseline and week 6Population: Treated Set with values for FPG at baseline and at week 6. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=1413 Participants
Patients pre-treated with linagliptin
|
New Lina
n=531 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Change in FPG From Baseline to Week 6
|
1.21 mg/dL
Standard Deviation 30.54
|
-15.17 mg/dL
Standard Deviation 30.84
|
SECONDARY outcome
Timeframe: Baseline and week 18Population: Treated Set with values for FPG at baseline and at week 18. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=1270 Participants
Patients pre-treated with linagliptin
|
New Lina
n=499 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Change in FPG From Baseline to Week 18
|
2.13 mg/dL
Standard Deviation 31.47
|
-13.92 mg/dL
Standard Deviation 33.54
|
SECONDARY outcome
Timeframe: Baseline and week 30Population: Treated Set with values for FPG at baseline and at week 30. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=1166 Participants
Patients pre-treated with linagliptin
|
New Lina
n=466 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Change in FPG From Baseline to Week 30
|
1.52 mg/dL
Standard Deviation 31.84
|
-16.17 mg/dL
Standard Deviation 33.00
|
SECONDARY outcome
Timeframe: Baseline and week 42Population: Treated Set with values for FPG at baseline and at week 42. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=1073 Participants
Patients pre-treated with linagliptin
|
New Lina
n=437 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Change in FPG From Baseline to Week 42
|
2.97 mg/dL
Standard Deviation 31.07
|
-11.87 mg/dL
Standard Deviation 31.27
|
SECONDARY outcome
Timeframe: Baseline and week 54Population: Treated Set with values for FPG at baseline and at week 54. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=1004 Participants
Patients pre-treated with linagliptin
|
New Lina
n=416 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Change in FPG From Baseline to Week 54
|
3.44 mg/dL
Standard Deviation 30.52
|
-12.62 mg/dL
Standard Deviation 30.96
|
SECONDARY outcome
Timeframe: Baseline and week 66Population: Treated Set with values for FPG at baseline and at week 66. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=955 Participants
Patients pre-treated with linagliptin
|
New Lina
n=398 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Change in FPG From Baseline to Week 66
|
0.88 mg/dL
Standard Deviation 31.96
|
-12.87 mg/dL
Standard Deviation 30.16
|
SECONDARY outcome
Timeframe: Baseline and week 78Population: Treated Set with values for FPG at baseline and at week 78. Values after rescue therapy are set to missing.
Outcome measures
| Measure |
Old Lina
n=904 Participants
Patients pre-treated with linagliptin
|
New Lina
n=366 Participants
Patients pre-treated with placebo
|
|---|---|---|
|
Change in FPG From Baseline to Week 78
|
1.90 mg/dL
Standard Deviation 34.11
|
-13.64 mg/dL
Standard Deviation 31.67
|
Adverse Events
Old Lina
Serious events: 158 serious events
Other events: 784 other events
Deaths: 0 deaths
New Lina
Serious events: 52 serious events
Other events: 285 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Old Lina
n=1532 participants at risk
Patients pre-treated with linagliptin
|
New Lina
n=589 participants at risk
Patients pre-treated with placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1532 • 78 weeks
|
0.68%
4/589 • 78 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.26%
4/1532 • 78 weeks
|
0.51%
3/589 • 78 weeks
|
|
Cardiac disorders
Angina unstable
|
0.26%
4/1532 • 78 weeks
|
0.34%
2/589 • 78 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.13%
2/1532 • 78 weeks
|
0.34%
2/589 • 78 weeks
|
|
Cardiac disorders
Atrial flutter
|
0.13%
2/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Cardiac disorders
Atrial tachycardia
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Cardiac disorders
Bradycardia
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.20%
3/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Cardiac disorders
Cardiac failure acute
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Cardiac disorders
Cardiac failure chronic
|
0.07%
1/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Cardiac disorders
Cardiac tamponade
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.20%
3/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Cardiac disorders
Left ventricular failure
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.13%
2/1532 • 78 weeks
|
1.0%
6/589 • 78 weeks
|
|
Cardiac disorders
Myocardial ischaemia
|
0.13%
2/1532 • 78 weeks
|
0.34%
2/589 • 78 weeks
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Congenital, familial and genetic disorders
Dolichocolon
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Endocrine disorders
Goitre
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Eye disorders
Cataract
|
0.13%
2/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Eye disorders
Diabetic retinopathy
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Eye disorders
Macular hole
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Gastrointestinal disorders
Anal fistula
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.13%
2/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.13%
2/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Gastrointestinal disorders
Peritoneal cyst
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Gastrointestinal disorders
Volvulus
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Gastrointestinal disorders
Chest discomfort
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
General disorders
Chest pain
|
0.33%
5/1532 • 78 weeks
|
0.34%
2/589 • 78 weeks
|
|
General disorders
Generalised oedema
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
General disorders
Local swelling
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1532 • 78 weeks
|
0.34%
2/589 • 78 weeks
|
|
General disorders
Polyp
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
General disorders
Sudden cardiac death
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
General disorders
Ulcer
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
General disorders
Vaccination site hypersensitivity
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Immune system disorders
Polyarteritis nodosa
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Abscess limb
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Infections and infestations
Amoebic dysentery
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Anal abscess
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Infections and infestations
Appendicitis perforated
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Bronchitis
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Campylobacter intestinal infection
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Cellulitis
|
0.26%
4/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Chikungunya virus infection
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Infections and infestations
Dengue fever
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Endocarditis
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.26%
4/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Gastrointestinal infection
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Infections and infestations
Infected skin ulcer
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Infections and infestations
Pneumonia
|
0.20%
3/1532 • 78 weeks
|
0.34%
2/589 • 78 weeks
|
|
Infections and infestations
Post procedural infection
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Postoperative wound infection
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Infections and infestations
Septic shock
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Vestibular neuronitis
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/1532 • 78 weeks
|
0.34%
2/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Head injury
|
0.13%
2/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.07%
1/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Peripheral nerve injury
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.20%
3/1532 • 78 weeks
|
0.34%
2/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.13%
2/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.13%
2/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.20%
3/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.20%
3/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.20%
3/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone sarcoma
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.20%
3/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.13%
2/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.13%
2/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.07%
1/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteoma
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.46%
7/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.13%
2/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsillar neoplasm
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Nervous system disorders
Cerebral ischaemia
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
3/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Nervous system disorders
Cervical myelopathy
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Nervous system disorders
Dizziness
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Nervous system disorders
Headache
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Nervous system disorders
Intracranial aneurysm
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Nervous system disorders
Ischaemic stroke
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Nervous system disorders
Nerve root compression
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Nervous system disorders
Presyncope
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Nervous system disorders
Radiculopathy
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Renal and urinary disorders
Calculus ureteric
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.07%
1/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.26%
4/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
0.13%
2/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Renal and urinary disorders
Renal failure chronic
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.07%
1/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.13%
2/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Reproductive system and breast disorders
Fallopian tube cyst
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.13%
2/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Surgical and medical procedures
Intra-uterine contraceptive device removal
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Vascular disorders
Hypertension
|
0.13%
2/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Vascular disorders
Hypertensive crisis
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Vascular disorders
Hypertensive emergency
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.07%
1/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/1532 • 78 weeks
|
0.17%
1/589 • 78 weeks
|
|
Vascular disorders
Varicose vein
|
0.07%
1/1532 • 78 weeks
|
0.00%
0/589 • 78 weeks
|
Other adverse events
| Measure |
Old Lina
n=1532 participants at risk
Patients pre-treated with linagliptin
|
New Lina
n=589 participants at risk
Patients pre-treated with placebo
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.7%
164/1532 • 78 weeks
|
10.5%
62/589 • 78 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
122/1532 • 78 weeks
|
9.2%
54/589 • 78 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.8%
74/1532 • 78 weeks
|
5.6%
33/589 • 78 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
24.5%
376/1532 • 78 weeks
|
20.5%
121/589 • 78 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
13.1%
200/1532 • 78 weeks
|
14.4%
85/589 • 78 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
69/1532 • 78 weeks
|
5.3%
31/589 • 78 weeks
|
|
Vascular disorders
Hypertension
|
4.4%
67/1532 • 78 weeks
|
5.1%
30/589 • 78 weeks
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Other - 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