Trial Outcomes & Findings for Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment (NCT NCT01087502)
NCT ID: NCT01087502
Last Updated: 2014-06-27
Results Overview
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c, renal function impairment and prior use of antidiabetic agents.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
241 participants
Primary outcome timeframe
Baseline and week 12
Results posted on
2014-06-27
Participant Flow
241 patients were randomised to treatment with linagliptin 5mg (n=118) or placebo/glimepiride (n=123). All randomised patients were treated. For the final analysis, one study site was excluded due to serious non-compliance resulting in 122 patients in the placebo/glimepiride group and 113 patients in the linagliptin group.
Participant milestones
| Measure |
Placebo/Glimepiride
Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
|
Linagliptin 5 mg
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Up to Interim Analysis (Week 12)
STARTED
|
123
|
118
|
|
Up to Interim Analysis (Week 12)
COMPLETED
|
114
|
110
|
|
Up to Interim Analysis (Week 12)
NOT COMPLETED
|
9
|
8
|
|
Up to Final Analysis (Week 52)
STARTED
|
123
|
118
|
|
Up to Final Analysis (Week 52)
COMPLETED
|
90
|
95
|
|
Up to Final Analysis (Week 52)
NOT COMPLETED
|
33
|
23
|
Reasons for withdrawal
| Measure |
Placebo/Glimepiride
Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
|
Linagliptin 5 mg
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Up to Interim Analysis (Week 12)
Adverse Event
|
5
|
4
|
|
Up to Interim Analysis (Week 12)
Protocol Violation
|
1
|
1
|
|
Up to Interim Analysis (Week 12)
Withdrawal by Subject
|
1
|
1
|
|
Up to Interim Analysis (Week 12)
Lack of Efficacy
|
1
|
0
|
|
Up to Interim Analysis (Week 12)
Other reason not described above
|
1
|
2
|
|
Up to Final Analysis (Week 52)
Adverse Event
|
17
|
10
|
|
Up to Final Analysis (Week 52)
Lack of Efficacy
|
1
|
2
|
|
Up to Final Analysis (Week 52)
Protocol Violation
|
4
|
0
|
|
Up to Final Analysis (Week 52)
Lost to Follow-up
|
2
|
0
|
|
Up to Final Analysis (Week 52)
Withdrawal by Subject
|
3
|
2
|
|
Up to Final Analysis (Week 52)
Study site excluded from analysis
|
1
|
5
|
|
Up to Final Analysis (Week 52)
Other reason not described above
|
5
|
4
|
Baseline Characteristics
Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment
Baseline characteristics by cohort
| Measure |
Placebo/Glimepiride
n=122 Participants
Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
|
Linagliptin 5 mg
n=113 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 10.0 • n=99 Participants
|
66.9 years
STANDARD_DEVIATION 9.4 • n=107 Participants
|
66.2 years
STANDARD_DEVIATION 9.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
149 Participants
n=206 Participants
|
|
Gender
Female
|
43 participants
n=99 Participants
|
44 participants
n=107 Participants
|
87 participants
n=206 Participants
|
|
Gender
Male
|
80 participants
n=99 Participants
|
74 participants
n=107 Participants
|
154 participants
n=206 Participants
|
|
Body mass index (BMI) continuous
|
31.93 kg/m^2
STANDARD_DEVIATION 6.27 • n=99 Participants
|
32.20 kg/m^2
STANDARD_DEVIATION 6.13 • n=107 Participants
|
32.06 kg/m^2
STANDARD_DEVIATION 6.19 • n=206 Participants
|
|
Glycosylated Hemoglobin A1 (HbA1c)
|
8.02 Percent
STANDARD_DEVIATION 0.94 • n=99 Participants
|
8.08 Percent
STANDARD_DEVIATION 0.88 • n=107 Participants
|
8.05 Percent
STANDARD_DEVIATION 0.91 • n=206 Participants
|
|
Fasting Plasma Glucose (FPG)
|
149.3 mg/dL
STANDARD_DEVIATION 53.0 • n=99 Participants
|
154.4 mg/dL
STANDARD_DEVIATION 46.1 • n=107 Participants
|
151.8 mg/dL
STANDARD_DEVIATION 49.7 • n=206 Participants
|
|
eGFR based on Modification of Diet in Renal Disease (MDRD) formula
>=90 (normal renal function)
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
eGFR based on Modification of Diet in Renal Disease (MDRD) formula
60 to <90 (mild renal impairment)
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
eGFR based on Modification of Diet in Renal Disease (MDRD) formula
30 to <60 (moderate renal impairment)
|
73 participants
n=99 Participants
|
76 participants
n=107 Participants
|
149 participants
n=206 Participants
|
|
eGFR based on Modification of Diet in Renal Disease (MDRD) formula
<30 (severe or endstage renal impairment)
|
45 participants
n=99 Participants
|
36 participants
n=107 Participants
|
81 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 12Population: FAS consisting of all randomised patients who were treated with at least one dose of study drug, had a baseline, and at least 1 on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as the imputation rule. Results for primary endpoint below are the ones reproduced without patients from the excluded study site.
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c, renal function impairment and prior use of antidiabetic agents.
Outcome measures
| Measure |
Placebo
n=120 Participants
Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
|
Linagliptin 5 mg
n=113 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
HbA1c Change From Baseline to Week 12
|
-0.11 Percent
Standard Error 0.11
|
-0.53 Percent
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52Population: FAS. Last observation carried forward (LOCF) was used as the imputation rule. Results do not contain data of patients from the excluded study site.
HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent over time minus the baseline HbA1c percent. This outcome measure only provides descriptive statistics without any modelling.
Outcome measures
| Measure |
Placebo
n=120 Participants
Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
|
Linagliptin 5 mg
n=113 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
HbA1c Change From Baseline Over Time
Week 4 (N=120, 113)
|
-0.08 Percent
Standard Deviation 0.42
|
-0.29 Percent
Standard Deviation 0.35
|
|
HbA1c Change From Baseline Over Time
Week 8 (N=120, 113)
|
-0.09 Percent
Standard Deviation 0.68
|
-0.47 Percent
Standard Deviation 0.49
|
|
HbA1c Change From Baseline Over Time
Week 12 (N=120, 113)
|
-0.08 Percent
Standard Deviation 0.79
|
-0.50 Percent
Standard Deviation 0.59
|
|
HbA1c Change From Baseline Over Time
Week 16 (N=120, 113)
|
-0.31 Percent
Standard Deviation 0.84
|
-0.47 Percent
Standard Deviation 0.61
|
|
HbA1c Change From Baseline Over Time
Week 20 (N=120, 113)
|
-0.48 Percent
Standard Deviation 0.88
|
-0.48 Percent
Standard Deviation 0.63
|
|
HbA1c Change From Baseline Over Time
Week 24 (N=120, 113)
|
-0.51 Percent
Standard Deviation 0.93
|
-0.52 Percent
Standard Deviation 0.66
|
|
HbA1c Change From Baseline Over Time
Week 28 (N=120, 113)
|
-0.47 Percent
Standard Deviation 0.93
|
-0.50 Percent
Standard Deviation 0.68
|
|
HbA1c Change From Baseline Over Time
Week 34 (N=120, 113)
|
-0.37 Percent
Standard Deviation 0.93
|
-0.45 Percent
Standard Deviation 0.69
|
|
HbA1c Change From Baseline Over Time
Week 40 (N=120, 113)
|
-0.23 Percent
Standard Deviation 0.95
|
-0.42 Percent
Standard Deviation 0.73
|
|
HbA1c Change From Baseline Over Time
Week 46 (N=120, 113)
|
-0.24 Percent
Standard Deviation 0.96
|
-0.40 Percent
Standard Deviation 0.75
|
|
HbA1c Change From Baseline Over Time
Week 52 (N=120, 113)
|
-0.25 Percent
Standard Deviation 0.92
|
-0.40 Percent
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: One patient in the Placebo/Glimepiride arm and one patient in the Linagliptin arm without FPG on-treatment value. Results do not contain data of patients from the excluded study site.
This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.
Outcome measures
| Measure |
Placebo
n=119 Participants
Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
|
Linagliptin 5 mg
n=112 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Fasting Plasma Glucose (FPG) Change From Baseline to Week 12
|
9.53 mg/dL
Standard Error 8.01
|
0.24 mg/dL
Standard Error 7.71
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52Population: FAS. Last observation carried forward (LOCF) was used as the imputation rule. Results do not contain data of patients from the excluded study site.
This change from baseline reflects the FPG over time minus the baseline FPG. This outcome measure only provides descriptive statistics without any modelling.
Outcome measures
| Measure |
Placebo
n=119 Participants
Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
|
Linagliptin 5 mg
n=112 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Fasting Plasma Glucose (FPG) Change From Baseline Over Time
Week 4 (N=119, 112)
|
9.80 mg/dL
Standard Deviation 54.94
|
-10.55 mg/dL
Standard Deviation 45.80
|
|
Fasting Plasma Glucose (FPG) Change From Baseline Over Time
Week 8 (N=119, 112)
|
8.96 mg/dL
Standard Deviation 53.30
|
-11.25 mg/dL
Standard Deviation 52.32
|
|
Fasting Plasma Glucose (FPG) Change From Baseline Over Time
Week 12 (N=119, 112)
|
6.23 mg/dL
Standard Deviation 58.20
|
-6.26 mg/dL
Standard Deviation 52.59
|
|
Fasting Plasma Glucose (FPG) Change From Baseline Over Time
Week 20 (N=119, 112)
|
-9.66 mg/dL
Standard Deviation 60.60
|
-5.92 mg/dL
Standard Deviation 57.68
|
|
Fasting Plasma Glucose (FPG) Change From Baseline Over Time
Week 24 (N=119, 112)
|
-8.83 mg/dL
Standard Deviation 54.84
|
-12.78 mg/dL
Standard Deviation 62.29
|
|
Fasting Plasma Glucose (FPG) Change From Baseline Over Time
Week 28 (N=119, 112)
|
-9.67 mg/dL
Standard Deviation 58.31
|
-9.31 mg/dL
Standard Deviation 61.01
|
|
Fasting Plasma Glucose (FPG) Change From Baseline Over Time
Week 34 (N=119, 112)
|
-9.95 mg/dL
Standard Deviation 58.47
|
-2.78 mg/dL
Standard Deviation 64.55
|
|
Fasting Plasma Glucose (FPG) Change From Baseline Over Time
Week 40 (N=119, 112)
|
-0.75 mg/dL
Standard Deviation 61.94
|
-2.69 mg/dL
Standard Deviation 68.43
|
|
Fasting Plasma Glucose (FPG) Change From Baseline Over Time
Week 46 (N=119, 112)
|
-2.64 mg/dL
Standard Deviation 60.83
|
-2.03 mg/dL
Standard Deviation 71.30
|
|
Fasting Plasma Glucose (FPG) Change From Baseline Over Time
Week 52 (N=119, 112)
|
-3.10 mg/dL
Standard Deviation 58.27
|
3.09 mg/dL
Standard Deviation 69.03
|
SECONDARY outcome
Timeframe: Baseline, week 12 and week 52Population: FAS with baseline HbA1c \>=7% and non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site.
The percentage of patients with an HbA1c value below 7% at week 12 and week 52 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively, they were considered a failure, so HbA1c above 7%.
Outcome measures
| Measure |
Placebo
n=110 Participants
Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
|
Linagliptin 5 mg
n=108 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Percentage of Patients With HbA1c <7.0%
Week 12 (N=110, 108)
|
9.1 percentage of patients
|
19.4 percentage of patients
|
|
Percentage of Patients With HbA1c <7.0%
Week 52 (N=110, 104)
|
11.8 percentage of patients
|
22.1 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline, week 12 and week 52Population: FAS with baseline HbA1c \>=6.5% and non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site.
The percentage of patients with an HbA1c value below 6.5% at week 12 and week 52 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c above 6.5%.
Outcome measures
| Measure |
Placebo
n=120 Participants
Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
|
Linagliptin 5 mg
n=115 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Percentage of Patients With HbA1c <6.5%
Week 52 (N=119, 111)
|
6.7 percentage of patients
|
9.9 percentage of patients
|
|
Percentage of Patients With HbA1c <6.5%
Week 12 (N=120, 115)
|
5.0 percentage of patients
|
6.1 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline, week 12 and week 52Population: FAS with non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site.
The percentage of patients with an HbA1c reduction of ≥0.5% at week 12 and week 52 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c reduction less than 0.5%.
Outcome measures
| Measure |
Placebo
n=121 Participants
Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
|
Linagliptin 5 mg
n=117 Participants
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%
Week 52 (N=120, 113)
|
23.3 percentage of patients
|
34.5 percentage of patients
|
|
Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%
Week 12 (N= 121, 117)
|
24.0 percentage of patients
|
49.6 percentage of patients
|
SECONDARY outcome
Timeframe: Week 12, 24 and 52Population: FAS original results (OR). Original results analysis means that data is analyzed exactly as observed, values after rescue medication are not set to missing and no imputation rule is applied for replacing the missing values.
Trough levels of concentration of Linagliptin in plasma.
Outcome measures
| Measure |
Placebo
n=113 Participants
Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
|
Linagliptin 5 mg
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Plasma Concentration of Linagliptin at Trough
Week 12 (N=103)
|
7.77 Nmol/L
Geometric Coefficient of Variation 36.43
|
—
|
|
Plasma Concentration of Linagliptin at Trough
Week 24 (N=103)
|
7.62 Nmol/L
Geometric Coefficient of Variation 41.04
|
—
|
|
Plasma Concentration of Linagliptin at Trough
Week 52 (N=105)
|
5.94 Nmol/L
Geometric Coefficient of Variation 107.40
|
—
|
Adverse Events
Placebo/Glimepiride
Serious events: 36 serious events
Other events: 110 other events
Deaths: 0 deaths
Linagliptin 5 mg
Serious events: 28 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Glimepiride
n=122 participants at risk
Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
|
Linagliptin 5 mg
n=113 participants at risk
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
1.6%
2/122 • 52 weeks
|
2.7%
3/113 • 52 weeks
|
|
Infections and infestations
Cellulitis
|
2.5%
3/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.82%
1/122 • 52 weeks
|
1.8%
2/113 • 52 weeks
|
|
Infections and infestations
Sepsis
|
1.6%
2/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Infections and infestations
Gas gangrene
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Infections and infestations
Localised infection
|
0.82%
1/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Infections and infestations
Device related infection
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Infections and infestations
Endocarditis enterococcal
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Infections and infestations
Lymphangitis
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Infections and infestations
Otitis externa
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Infections and infestations
Viral infection
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.82%
1/122 • 52 weeks
|
1.8%
2/113 • 52 weeks
|
|
Metabolism and nutrition disorders
Fluid retention
|
1.6%
2/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Nervous system disorders
Cerebral infarction
|
1.6%
2/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Nervous system disorders
Brachial plexopathy
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Eye disorders
Amaurosis fugax
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
4.1%
5/122 • 52 weeks
|
3.5%
4/113 • 52 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
2.5%
3/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.82%
1/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Vascular disorders
Hypertension
|
1.6%
2/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.82%
1/122 • 52 weeks
|
1.8%
2/113 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
2/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/122 • 52 weeks
|
1.8%
2/113 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/122 • 52 weeks
|
1.8%
2/113 • 52 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.82%
1/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
0.82%
1/122 • 52 weeks
|
1.8%
2/113 • 52 weeks
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Renal and urinary disorders
Renal failure chronic
|
0.82%
1/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Renal and urinary disorders
Renal impairment
|
0.82%
1/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
General disorders
Chest pain
|
3.3%
4/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
General disorders
Oedema peripheral
|
0.82%
1/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
General disorders
Fatigue
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Investigations
Liver function test abnormal
|
0.82%
1/122 • 52 weeks
|
0.00%
0/113 • 52 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.82%
1/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/122 • 52 weeks
|
0.88%
1/113 • 52 weeks
|
Other adverse events
| Measure |
Placebo/Glimepiride
n=122 participants at risk
Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
|
Linagliptin 5 mg
n=113 participants at risk
Patients randomized to receive treatment with Linagliptin 5mg
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
14.8%
18/122 • 52 weeks
|
18.6%
21/113 • 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
8.2%
10/122 • 52 weeks
|
9.7%
11/113 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
6.6%
8/122 • 52 weeks
|
7.1%
8/113 • 52 weeks
|
|
Infections and infestations
Bronchitis
|
6.6%
8/122 • 52 weeks
|
6.2%
7/113 • 52 weeks
|
|
Infections and infestations
Influenza
|
5.7%
7/122 • 52 weeks
|
3.5%
4/113 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
69.7%
85/122 • 52 weeks
|
59.3%
67/113 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.4%
20/122 • 52 weeks
|
17.7%
20/113 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.7%
7/122 • 52 weeks
|
7.1%
8/113 • 52 weeks
|
|
Nervous system disorders
Headache
|
6.6%
8/122 • 52 weeks
|
3.5%
4/113 • 52 weeks
|
|
Nervous system disorders
Dizziness
|
5.7%
7/122 • 52 weeks
|
5.3%
6/113 • 52 weeks
|
|
Vascular disorders
Hypertension
|
4.9%
6/122 • 52 weeks
|
7.1%
8/113 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
7/122 • 52 weeks
|
3.5%
4/113 • 52 weeks
|
|
Gastrointestinal disorders
Constipation
|
9.8%
12/122 • 52 weeks
|
5.3%
6/113 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
7/122 • 52 weeks
|
5.3%
6/113 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
3/122 • 52 weeks
|
5.3%
6/113 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
4/122 • 52 weeks
|
5.3%
6/113 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
7/122 • 52 weeks
|
12.4%
14/113 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.6%
8/122 • 52 weeks
|
7.1%
8/113 • 52 weeks
|
|
General disorders
Oedema peripheral
|
7.4%
9/122 • 52 weeks
|
2.7%
3/113 • 52 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
4.1%
5/122 • 52 weeks
|
5.3%
6/113 • 52 weeks
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER