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Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01778049
Recruitment Status : Completed
First Posted : January 29, 2013
Results First Posted : April 4, 2016
Last Update Posted : April 4, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: BI 10773
Drug: BI 10773 Placebo
Drug: BI 10773 / BI 1356
Drug: BI 10773 / BI 1356 Placebo
Enrollment 708
Recruitment Details Subjects randomised to 16 week(wk) open-label (OL) treatment with either empagliflozin (empa) 25 or empa 10 treatment, thereafter subjects entered to 1 wk open label placebo (Plc) add-on period in order to complete further eligibility evaluations before being randomised into 1 of the 24 wk double-blind treatment groups.
Pre-assignment Details This was a randomised, double-blind, multi-national, parallel group trial. In this trial the treatment effects of linagliptin (lina) 5 compared with Plc were analysed as add-on to either empa 25 or empa 10. All trial treatments were administered in addition to metformin background treatment.
Arm/Group Title Empa 10 mg OL Empa 25 mg OL Lina5 (E10) Plc (E10) Lina5 (E25) Plc (E25)
Hide Arm/Group Description Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period. Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period. Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period. Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period. Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period. Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
Period Title: Open Label Treatment Period
Started 354 355 0 0 0 0
Completed 256 226 0 0 0 0
Not Completed 98 129 0 0 0 0
Reason Not Completed
Adverse Event             5             15             0             0             0             0
Lack of Efficacy             1             1             0             0             0             0
Protocol Violation             5             5             0             0             0             0
Lost to Follow-up             4             3             0             0             0             0
Withdrawal by Subject             4             10             0             0             0             0
Not treated             2             1             0             0             0             0
Other reason not defined above             77             94             0             0             0             0
Period Title: Double Blind Treatment Period
Started 0 0 126 130 114 112
Completed 0 0 111 118 102 105
Not Completed 0 0 15 12 12 7
Reason Not Completed
Adverse Event             0             0             4             5             3             2
Lack of Efficacy             0             0             0             0             0             1
Protocol Violation             0             0             2             0             0             0
Lost to Follow-up             0             0             4             1             5             2
Withdrawal by Subject             0             0             1             2             0             1
Not treated             0             0             0             2             2             0
Other reason not defined above             0             0             4             2             2             1
Arm/Group Title Empa 10 mg OL Empa 25 mg OL Total
Hide Arm/Group Description Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period. Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period. Total of all reporting groups
Overall Number of Baseline Participants 352 354 706
Hide Baseline Analysis Population Description
The open-label treated set (OLTS) was used for the open label treatment period. This analysis set consisted of all patients who received at least 1 dose of open-label treatment during the trial.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 352 participants 354 participants 706 participants
57.0  (9.6) 56.7  (9.9) 56.8  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 352 participants 354 participants 706 participants
Female
145
  41.2%
161
  45.5%
306
  43.3%
Male
207
  58.8%
193
  54.5%
400
  56.7%
1.Primary Outcome
Title Change From Baseline of HbA1c After 24 Weeks of Treatment.
Hide Description

Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term “baseline” was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as “pre-treatment". Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference.

Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial.

Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (OC)
Arm/Group Title Lina5 (E10) Plc (E10) Lina5 (E25) Plc (E25)
Hide Arm/Group Description:
Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
Overall Number of Participants Analyzed 111 110 98 98
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of HbA1c
-0.53  (0.07) -0.21  (0.07) -0.58  (0.07) -0.10  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lina5 (E10), Plc (E10)
Comments Superiority of lina5 (E10) vs. Plc (E10): change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c as linear covariates & baseline estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method Mixed Model Repeated Measure (MMRM)
Comments The unstructured covariance structure has been used to fit the mixed model.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.32
Confidence Interval 95%
-0.52 to -0.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Mean Difference (Final Values) is actually the adjusted mean difference calculated as lina5 (E10) minus Plc (E10) value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lina5 (E25), Plc (E25)
Comments Superiority of lina5 (E25) vs. Plc (E25): change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c as linear covariates & baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method MMRM
Comments The unstructured covariance structure has been used to fit the mixed model.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.47
Confidence Interval 95%
-0.66 to -0.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E25) minus Plc (E25).
2.Secondary Outcome
Title Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks.
Hide Description Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication, i.e. FPG change from baseline at Week 24.
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (OC)
Arm/Group Title Lina5 (E10) Plc (E10) Lina5 (E25) Plc (E25)
Hide Arm/Group Description:
Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
Overall Number of Participants Analyzed 108 107 93 94
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.44  (0.18) 0.21  (0.18) -0.68  (0.15) -0.24  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lina5 (E10), Plc (E10)
Comments Superiority of lina5 (E10) vs. Plc (E10): change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c & baseline eGFR as linear covariates, geographical region, treatment, visit, visit by treatment interaction as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0103
Comments [Not Specified]
Method MMRM
Comments The unstructured covariance structure has been used to fit the mixed model.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.65
Confidence Interval 95%
-1.15 to -0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.25
Estimation Comments Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E10) minus Plc (E10).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lina5 (E25), Plc (E25)
Comments Superiority of lina5 (E25) vs. Plc (E25): change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c & baseline eGFR as linear covariates, geographical region, treatment, visit, visit by treatment interaction as fixed effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0452
Comments [Not Specified]
Method MMRM
Comments The unstructured covariance structure has been used to fit the mixed model.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.44
Confidence Interval 95%
-0.87 to -0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.22
Estimation Comments Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E25) minus Plc (E25).
Time Frame From first drug administration until 7 days after the last drug administration, up to 212 days (OL treatment period) and 205 days (double blind treatment period).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Empa 10 mg OL Empa 25 mg OL Lina5 (E10) Plc (E10) Lina5 (E25) Plc (E25)
Hide Arm/Group Description Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period. Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period. Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period. Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period. Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period. Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
All-Cause Mortality
Empa 10 mg OL Empa 25 mg OL Lina5 (E10) Plc (E10) Lina5 (E25) Plc (E25)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Empa 10 mg OL Empa 25 mg OL Lina5 (E10) Plc (E10) Lina5 (E25) Plc (E25)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/352 (3.41%)   12/354 (3.39%)   4/126 (3.17%)   5/128 (3.91%)   3/112 (2.68%)   4/112 (3.57%) 
Blood and lymphatic system disorders             
Pancytopenia  1  0/352 (0.00%)  1/354 (0.28%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Cardiac disorders             
Angina unstable  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Atrial fibrillation  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Atrial flutter  1  0/352 (0.00%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Coronary artery disease  1  0/352 (0.00%)  0/354 (0.00%)  0/126 (0.00%)  1/128 (0.78%)  0/112 (0.00%)  0/112 (0.00%) 
Myocardial infarction  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  1/128 (0.78%)  0/112 (0.00%)  0/112 (0.00%) 
Myocardial ischaemia  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Tachycardia  1  0/352 (0.00%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Gastrointestinal disorders             
Diverticulum intestinal  1  0/352 (0.00%)  1/354 (0.28%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Gastrointestinal haemorrhage  1  0/352 (0.00%)  1/354 (0.28%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Intestinal polyp  1  0/352 (0.00%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Pancreatitis acute  1  2/352 (0.57%)  0/354 (0.00%)  1/126 (0.79%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/352 (0.00%)  1/354 (0.28%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Vomiting  1  0/352 (0.00%)  0/354 (0.00%)  1/126 (0.79%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
General disorders             
Calcinosis  1  0/352 (0.00%)  1/354 (0.28%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Chest pain  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Death  1  0/352 (0.00%)  1/354 (0.28%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
General physical health deterioration  1  0/352 (0.00%)  0/354 (0.00%)  1/126 (0.79%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Hepatobiliary disorders             
Cholecystitis acute  1  2/352 (0.57%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Liver injury  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Infections and infestations             
Abscess limb  1  0/352 (0.00%)  1/354 (0.28%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Bronchitis  1  0/352 (0.00%)  1/354 (0.28%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Gangrene  1  0/352 (0.00%)  1/354 (0.28%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Infectious colitis  1  0/352 (0.00%)  1/354 (0.28%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Osteomyelitis  1  0/352 (0.00%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  2/112 (1.79%) 
Pneumonia  1  0/352 (0.00%)  0/354 (0.00%)  1/126 (0.79%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Upper respiratory tract infection  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Urinary tract infection  1  0/352 (0.00%)  0/354 (0.00%)  1/126 (0.79%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Injury, poisoning and procedural complications             
Fall  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Skull fractured base  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Investigations             
Amylase increased  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Musculoskeletal and connective tissue disorders             
Back pain  1  0/352 (0.00%)  0/354 (0.00%)  1/126 (0.79%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Haemarthrosis  1  0/352 (0.00%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Neck pain  1  0/352 (0.00%)  0/354 (0.00%)  0/126 (0.00%)  1/128 (0.78%)  0/112 (0.00%)  0/112 (0.00%) 
Rhabdomyolysis  1  0/352 (0.00%)  0/354 (0.00%)  1/126 (0.79%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Rotator cuff syndrome  1  0/352 (0.00%)  0/354 (0.00%)  0/126 (0.00%)  1/128 (0.78%)  0/112 (0.00%)  0/112 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Pancreatic carcinoma metastatic  1  0/352 (0.00%)  1/354 (0.28%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Prostatic adenoma  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Nervous system disorders             
Cerebral haematoma  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Cerebral haemorrhage  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Cerebrovascular accident  1  0/352 (0.00%)  0/354 (0.00%)  0/126 (0.00%)  1/128 (0.78%)  0/112 (0.00%)  0/112 (0.00%) 
Ischaemic stroke  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Reproductive system and breast disorders             
Balanoposthitis  1  0/352 (0.00%)  0/354 (0.00%)  0/126 (0.00%)  1/128 (0.78%)  0/112 (0.00%)  0/112 (0.00%) 
Metrorrhagia  1  0/352 (0.00%)  1/354 (0.28%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Chronic obstructive pulmonary disease  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Nasal septum deviation  1  0/352 (0.00%)  1/354 (0.28%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Nasal turbinate hypertrophy  1  0/352 (0.00%)  1/354 (0.28%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Pharyngeal lesion  1  0/352 (0.00%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Skin and subcutaneous tissue disorders             
Dermatitis bullous  1  0/352 (0.00%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Dyshidrotic eczema  1  0/352 (0.00%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  1/112 (0.89%)  0/112 (0.00%) 
Vascular disorders             
Extremity necrosis  1  0/352 (0.00%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  1/112 (0.89%) 
Subclavian vein thrombosis  1  1/352 (0.28%)  0/354 (0.00%)  0/126 (0.00%)  0/128 (0.00%)  0/112 (0.00%)  0/112 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Empa 10 mg OL Empa 25 mg OL Lina5 (E10) Plc (E10) Lina5 (E25) Plc (E25)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   47/352 (13.35%)   38/354 (10.73%)   22/126 (17.46%)   10/128 (7.81%)   18/112 (16.07%)   21/112 (18.75%) 
Infections and infestations             
Nasopharyngitis  1  17/352 (4.83%)  5/354 (1.41%)  8/126 (6.35%)  3/128 (2.34%)  2/112 (1.79%)  8/112 (7.14%) 
Urinary tract infection  1  16/352 (4.55%)  23/354 (6.50%)  10/126 (7.94%)  6/128 (4.69%)  11/112 (9.82%)  7/112 (6.25%) 
Investigations             
Lipase increased  1  15/352 (4.26%)  10/354 (2.82%)  4/126 (3.17%)  1/128 (0.78%)  7/112 (6.25%)  7/112 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01778049     History of Changes
Other Study ID Numbers: 1275.10
2012-002271-34 ( EudraCT Number: EudraCT )
First Submitted: January 24, 2013
First Posted: January 29, 2013
Results First Submitted: March 4, 2016
Results First Posted: April 4, 2016
Last Update Posted: April 4, 2016