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Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01734785
Recruitment Status : Completed
First Posted : November 28, 2012
Results First Posted : April 18, 2016
Last Update Posted : July 11, 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: Linagliptin
Drug: Empagliflozin + Linagliptin
Drug: Empaglifozin placebo + Linagliptin placebo
Enrollment 607

Recruitment Details  
Pre-assignment Details 16-week open-label (OL) lina 5 period followed by a 1-week OL period with additional placebo administration preceded randomisation to double-blind treatment. Patients were randomised to double blind treatment only when they had not met glycaemic control criteria after the 16-week OL period. All treatments were administered in addition to metformin.
Arm/Group Title Empagliflozin 25 mg Empagliflozin 10 mg Placebo Linagliptin 5 mg
Hide Arm/Group Description Patients received 1 fixed dose combination (FDC) Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period. Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period. Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period. Patients received 5mg dose of Linagliptin (lina 5), administered orally, once daily for 16 weeks during the OL treatment period, thereafter patients received 1 matching placebo tablet to FDC empa 25/lina 5, and 1 matching placebo tablet to FDC empa 10/lina 5 per day in addition to lina 5 OL, for 1 week during the open-label placebo add-on treatment period.
Period Title: Open−Label Period
Started 0 0 0 606
Completed 0 0 0 333
Not Completed 0 0 0 273
Reason Not Completed
Adverse Event             0             0             0             9
Lack of Efficacy             0             0             0             1
Protocol Violation             0             0             0             13
Lost to Follow-up             0             0             0             14
Withdrawal by Subject             0             0             0             12
Other Reasons             0             0             0             224
Period Title: Double−Blind Period
Started 111 112 110 0
Completed 106 103 105 0
Not Completed 5 9 5 0
Reason Not Completed
Adverse Event             0             3             2             0
Lack of Efficacy             0             1             0             0
Protocol Violation             0             1             1             0
Lost to Follow-up             2             4             2             0
Withdrawal by Subject             2             0             0             0
Not treated             1             0             0             0
Arm/Group Title Empagliflozin 25 mg Empagliflozin 10 mg Placebo Total
Hide Arm/Group Description Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period. Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period. Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period. Total of all reporting groups
Overall Number of Baseline Participants 110 112 110 332
Hide Baseline Analysis Population Description
The treated set (TS) consisted of all patients who were randomised and treated with at least 1 dose of study drug during the double-blind part of the trial.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 112 participants 110 participants 332 participants
55.4  (9.9) 54.3  (9.5) 55.9  (9.6) 55.2  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 112 participants 110 participants 332 participants
Female
39
  35.5%
46
  41.1%
49
  44.5%
134
  40.4%
Male
71
  64.5%
66
  58.9%
61
  55.5%
198
  59.6%
1.Primary Outcome
Title HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment
Hide Description Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term ‘baseline’ was not used to refer to measurements before the administration of open-label medication.
Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all patients in the treated set (TS) who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.
Arm/Group Title Empagliflozin 25 mg Empagliflozin 10 mg Placebo
Hide Arm/Group Description:
Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
Overall Number of Participants Analyzed 110 109 106
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of HbA1c
-0.56  (0.08) -0.65  (0.08) 0.14  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empagliflozin 25 mg, Placebo
Comments Superiority of Empagliflozin 25 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) & baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The unstructured covariance structure has been used to fit the mixed model.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.70
Confidence Interval 95%
-0.93 to -0.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Empagliflozin 10 mg, Placebo
Comments Superiority of Empagliflozin 10 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) & baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The unstructured covariance structure has been used to fit the mixed model.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.79
Confidence Interval 95%
-1.02 to -0.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.
2.Secondary Outcome
Title Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.
Hide Description Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication.
Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS (OC)
Arm/Group Title Empagliflozin 25 mg Empagliflozin 10 mg Placebo
Hide Arm/Group Description:
Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
Overall Number of Participants Analyzed 109 109 106
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-1.75  (0.18) -1.46  (0.18) 0.34  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empagliflozin 25 mg, Placebo
Comments Superiority of Empagliflozin 25 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) & baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The unstructured covariance structure has been used to fit the mixed model.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.09
Confidence Interval 95%
-2.61 to -1.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.26
Estimation Comments Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Empagliflozin 10 mg, Placebo
Comments Superiority of Empagliflozin 10 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) & baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The unstructured covariance structure has been used to fit the mixed model.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.80
Confidence Interval 95%
-2.31 to -1.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.26
Estimation Comments Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.
3.Secondary Outcome
Title Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment
Hide Description Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication.
Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS (OC)
Arm/Group Title Empagliflozin 25 mg Empagliflozin 10 mg Placebo
Hide Arm/Group Description:
Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
Overall Number of Participants Analyzed 110 109 106
Least Squares Mean (Standard Error)
Unit of Measure: kg
-2.52  (0.25) -3.06  (0.25) -0.30  (0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empagliflozin 25 mg, Placebo
Comments Superiority of Empagliflozin 25 mg vs. placebo: change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) & baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The unstructured covariance structure has been used to fit the mixed model.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.22
Confidence Interval 95%
-2.92 to -1.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.36
Estimation Comments Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Empagliflozin 10 mg, Placebo
Comments Superiority of Empagliflozin 10 mg vs. placebo:change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) & baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments The unstructured covariance structure has been used to fit the mixed model.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.77
Confidence Interval 95%
-3.47 to -2.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.36
Estimation Comments Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.
Time Frame From first drug administration until 7 days after the last drug administration, up to 126 days (open label treatment period) and 176 days (double blind treatment period).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Empagliflozin 25 mg Empagliflozin 10 mg Placebo Linagliptin 5 mg
Hide Arm/Group Description Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period. Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period. Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period. Patients received 5mg dose of Linagliptin (lina 5), administered orally, once daily for 16 weeks during the OL treatment period, thereafter patients received 1 matching placebo tablet to FDC empa 25/lina 5, and 1 matching placebo tablet to FDC empa 10/lina 5 per day in addition to lina 5 OL, for 1 week during the open-label placebo add-on treatment period.
All-Cause Mortality
Empagliflozin 25 mg Empagliflozin 10 mg Placebo Linagliptin 5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Empagliflozin 25 mg Empagliflozin 10 mg Placebo Linagliptin 5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/110 (3.64%)   5/112 (4.46%)   10/110 (9.09%)   18/606 (2.97%) 
Cardiac disorders         
Atrial fibrillation  1  1/110 (0.91%)  0/112 (0.00%)  0/110 (0.00%)  0/606 (0.00%) 
Cardiac failure congestive  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Coronary artery disease  1  0/110 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/606 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  1/110 (0.91%)  0/112 (0.00%)  0/110 (0.00%)  0/606 (0.00%) 
Colitis  1  0/110 (0.00%)  1/112 (0.89%)  0/110 (0.00%)  0/606 (0.00%) 
Gastritis  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Intestinal obstruction  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Umbilical hernia  1  0/110 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/606 (0.00%) 
General disorders         
Oedema  1  0/110 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/606 (0.00%) 
Pyrexia  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Hepatobiliary disorders         
Hepatotoxicity  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Hypertransaminasaemia  1  0/110 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/606 (0.00%) 
Immune system disorders         
Hypersensitivity  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Infections and infestations         
Abscess  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Diarrhoea infectious  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Erysipelas  1  0/110 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  1/606 (0.17%) 
Gastroenteritis  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Pharyngitis bacterial  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Pneumonia  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Urosepsis  1  0/110 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/606 (0.00%) 
Wound infection  1  1/110 (0.91%)  0/112 (0.00%)  0/110 (0.00%)  0/606 (0.00%) 
Injury, poisoning and procedural complications         
Accidental overdose  1  0/110 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/606 (0.00%) 
Jaw fracture  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Metabolism and nutrition disorders         
Dehydration  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Metabolic acidosis  1  0/110 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  1/606 (0.17%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/110 (0.00%)  1/112 (0.89%)  0/110 (0.00%)  0/606 (0.00%) 
Intervertebral disc disorder  1  0/110 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/606 (0.00%) 
Intervertebral disc protrusion  1  1/110 (0.91%)  0/112 (0.00%)  0/110 (0.00%)  0/606 (0.00%) 
Osteoarthritis  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma of colon  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Basal cell carcinoma  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Bladder neoplasm  1  0/110 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/606 (0.00%) 
Breast cancer  1  0/110 (0.00%)  1/112 (0.89%)  0/110 (0.00%)  0/606 (0.00%) 
Nervous system disorders         
Cervical radiculopathy  1  0/110 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/606 (0.00%) 
Hydrocephalus  1  0/110 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/606 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Psychiatric disorders         
Major depression  1  0/110 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/606 (0.17%) 
Mania  1  0/110 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/606 (0.00%) 
Renal and urinary disorders         
Calculus ureteric  1  1/110 (0.91%)  0/112 (0.00%)  1/110 (0.91%)  0/606 (0.00%) 
Hydronephrosis  1  1/110 (0.91%)  0/112 (0.00%)  0/110 (0.00%)  0/606 (0.00%) 
Nephrolithiasis  1  1/110 (0.91%)  0/112 (0.00%)  0/110 (0.00%)  0/606 (0.00%) 
Renal failure acute  1  0/110 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  1/606 (0.17%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  0/110 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/606 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumothorax  1  0/110 (0.00%)  1/112 (0.89%)  0/110 (0.00%)  1/606 (0.17%) 
Surgical and medical procedures         
Abortion induced  1  0/110 (0.00%)  1/112 (0.89%)  0/110 (0.00%)  0/606 (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%
Empagliflozin 25 mg Empagliflozin 10 mg Placebo Linagliptin 5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/110 (10.00%)   19/112 (16.96%)   34/110 (30.91%)   78/606 (12.87%) 
Infections and infestations         
Nasopharyngitis  1  4/110 (3.64%)  5/112 (4.46%)  8/110 (7.27%)  25/606 (4.13%) 
Urinary tract infection  1  3/110 (2.73%)  8/112 (7.14%)  7/110 (6.36%)  28/606 (4.62%) 
Investigations         
Lipase increased  1  3/110 (2.73%)  4/112 (3.57%)  6/110 (5.45%)  10/606 (1.65%) 
Metabolism and nutrition disorders         
Hyperglycaemia  1  1/110 (0.91%)  1/112 (0.89%)  7/110 (6.36%)  6/606 (0.99%) 
Nervous system disorders         
Headache  1  2/110 (1.82%)  3/112 (2.68%)  8/110 (7.27%)  14/606 (2.31%) 
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: NCT01734785     History of Changes
Other Study ID Numbers: 1275.9
2012-002270-31 ( EudraCT Number: EudraCT )
First Submitted: November 16, 2012
First Posted: November 28, 2012
Results First Submitted: March 17, 2016
Results First Posted: April 18, 2016
Last Update Posted: July 11, 2016