Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002270-31 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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Not provided
| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.
Not provided
Not provided
Not provided
Not provided
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Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linagliptin | Active Comparator | 5 mg once daily |
|
| Empagliflozin + Linagliptin low dose | Experimental | 1 tablet once daily |
|
| Empagliflozin + Linagliptin high dose | Experimental | 1 tablet once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linagliptin | Drug | tablet |
| |
| Empagliflozin + Linagliptin |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment | 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. | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment. | Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication. | Baseline and 24 weeks |
| Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1275.9.01013 Boehringer Ingelheim Investigational Site | Gulf Shores | Alabama | United States | |||
| 1275.9.01009 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27913576 | Derived | Softeland E, Meier JJ, Vangen B, Toorawa R, Maldonado-Lutomirsky M, Broedl UC. Empagliflozin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Linagliptin and Metformin: A 24-Week Randomized, Double-Blind, Parallel-Group Trial. Diabetes Care. 2017 Feb;40(2):201-209. doi: 10.2337/dc16-1347. Epub 2016 Dec 2. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Empagliflozin 25 mg | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-Label Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Fixed dose combination. |
|
| Empagliflozin + Linagliptin | Drug | Fixed dose combination |
|
| Empagliflozin + Linagliptin | Drug | Fixed dose combination |
|
| Empagliflozin placebo + Linagliptin placebo | Drug | Matching Empagliflozin + Linagliptin low dose |
|
| Empagliflozin + Linagliptin | Drug | Fixed dose combination. |
|
Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication. |
| Baseline and 24 weeks |
| Norwalk |
| California |
| United States |
| 1275.9.01015 Boehringer Ingelheim Investigational Site | San Diego | California | United States |
| 1275.9.01017 Boehringer Ingelheim Investigational Site | San Diego | California | United States |
| 1275.9.01011 Boehringer Ingelheim Investigational Site | Northglenn | Colorado | United States |
| 1275.9.01010 Boehringer Ingelheim Investigational Site | Coral Gables | Florida | United States |
| 1275.9.01004 Boehringer Ingelheim Investigational Site | Miami | Florida | United States |
| 1275.9.01006 Boehringer Ingelheim Investigational Site | Oldsmar | Florida | United States |
| 1275.9.01001 Boehringer Ingelheim Investigational Site | Palm Coast | Florida | United States |
| 1275.9.01027 Boehringer Ingelheim Investigational Site | Port Orange | Florida | United States |
| 1275.9.01029 Boehringer Ingelheim Investigational Site | Blue Ridge | Georgia | United States |
| 1275.9.01003 Boehringer Ingelheim Investigational Site | Marietta | Georgia | United States |
| 1275.9.01022 Boehringer Ingelheim Investigational Site | Savannah | Georgia | United States |
| 1275.9.01031 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| 1275.9.01019 Boehringer Ingelheim Investigational Site | Methuen | Massachusetts | United States |
| 1275.9.01024 Boehringer Ingelheim Investigational Site | Troy | Michigan | United States |
| 1275.9.01023 Boehringer Ingelheim Investigational Site | St Louis | Missouri | United States |
| 1275.9.01002 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States |
| 1275.9.01007 Boehringer Ingelheim Investigational Site | Newington | New Hampshire | United States |
| 1275.9.01016 Boehringer Ingelheim Investigational Site | Asheboro | North Carolina | United States |
| 1275.9.01025 Boehringer Ingelheim Investigational Site | Burlington | North Carolina | United States |
| 1275.9.01014 Boehringer Ingelheim Investigational Site | Shelby | North Carolina | United States |
| 1275.9.01028 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina | United States |
| 1275.9.01018 Boehringer Ingelheim Investigational Site | Dayton | Ohio | United States |
| 1275.9.01005 Boehringer Ingelheim Investigational Site | Corvallis | Oregon | United States |
| 1275.9.01032 Boehringer Ingelheim Investigational Site | Corpus Christi | Texas | United States |
| 1275.9.01030 Boehringer Ingelheim Investigational Site | Houston | Texas | United States |
| 1275.9.01021 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States |
| 1275.9.61009 Boehringer Ingelheim Investigational Site | Liverpool | New South Wales | Australia |
| 1275.9.61001 Boehringer Ingelheim Investigational Site | St Leonards | New South Wales | Australia |
| 1275.9.61003 Boehringer Ingelheim Investigational Site | Carina Heights | Queensland | Australia |
| 1275.9.61002 Boehringer Ingelheim Investigational Site | Herston | Queensland | Australia |
| 1275.9.61006 Boehringer Ingelheim Investigational Site | Malvern | Victoria | Australia |
| 1275.9.61007 Boehringer Ingelheim Investigational Site | Nedlands | Western Australia | Australia |
| 1275.9.55002 Boehringer Ingelheim Investigational Site | Brasília | Brazil |
| 1275.9.55005 Boehringer Ingelheim Investigational Site | Goiânia | Brazil |
| 1275.9.55001 Boehringer Ingelheim Investigational Site | São Paulo | Brazil |
| 1275.9.55003 Boehringer Ingelheim Investigational Site | São Paulo | Brazil |
| 1275.9.55004 Boehringer Ingelheim Investigational Site | São Paulo | Brazil |
| 1275.9.01101 Boehringer Ingelheim Investigational Site | Burnaby | British Columbia | Canada |
| 1275.9.01103 Boehringer Ingelheim Investigational Site | Victoria | British Columbia | Canada |
| 1275.9.01105 Boehringer Ingelheim Investigational Site | Cornwall | Ontario | Canada |
| 1275.9.01106 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada |
| 1275.9.01104 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1275.9.01102 Boehringer Ingelheim Investigational Site | Waterloo | Ontario | Canada |
| 1275.9.34008 Boehringer Ingelheim Investigational Site | Barcelona | El Salvador |
| 1275.9.33006 Boehringer Ingelheim Investigational Site | Bourg-des-Comptes | France |
| 1275.9.33008 Boehringer Ingelheim Investigational Site | Dessenheim | France |
| 1275.9.33003 Boehringer Ingelheim Investigational Site | La Riche | France |
| 1275.9.33012 Boehringer Ingelheim Investigational Site | Paris | France |
| 1275.9.33002 Boehringer Ingelheim Investigational Site | Saint-Avertin | France |
| 1275.9.33005 Boehringer Ingelheim Investigational Site | Savonnières | France |
| 1275.9.33004 Boehringer Ingelheim Investigational Site | Tours | France |
| 1275.9.64005 Boehringer Ingelheim Investigational Site | Auckland, New Zealand | New Zealand |
| 1275.9.64006 Boehringer Ingelheim Investigational Site | Auckland, New Zealand | New Zealand |
| 1275.9.64008 Boehringer Ingelheim Investigational Site | Birkenhead Auckland | New Zealand |
| 1275.9.64007 Boehringer Ingelheim Investigational Site | Christchurch Central | New Zealand |
| 1275.9.64004 Boehringer Ingelheim Investigational Site | Christchurch, New Zealand | New Zealand |
| 1275.9.64002 Boehringer Ingelheim Investigational Site | Otahuhu Auckland | New Zealand |
| 1275.9.64001 Boehringer Ingelheim Investigational Site | Takapuna Auckland | New Zealand |
| 1275.9.64003 Boehringer Ingelheim Investigational Site | Tauranga, New Zealand | New Zealand |
| 1275.9.47001 Boehringer Ingelheim Investigational Site | Bergen | Norway |
| 1275.9.47002 Boehringer Ingelheim Investigational Site | Oslo | Norway |
| 1275.9.47003 Boehringer Ingelheim Investigational Site | Oslo | Norway |
| 1275.9.47007 Boehringer Ingelheim Investigational Site | Oslo | Norway |
| 1275.9.47006 Boehringer Ingelheim Investigational Site | Svelvik | Norway |
| 1275.9.82006 Boehringer Ingelheim Investigational Site | Daejeon | South Korea |
| 1275.9.82009 Boehringer Ingelheim Investigational Site | Deagu | South Korea |
| 1275.9.82002 Boehringer Ingelheim Investigational Site | Goyang | South Korea |
| 1275.9.82004 Boehringer Ingelheim Investigational Site | Seongnam | South Korea |
| 1275.9.82001 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1275.9.82005 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1275.9.82007 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1275.9.82008 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1275.9.82010 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1275.9.34011 Boehringer Ingelheim Investigational Site | A Coruña | Spain |
| 1275.9.34009 Boehringer Ingelheim Investigational Site | Alicante | Spain |
| 1275.9.34005 Boehringer Ingelheim Investigational Site | Badía Del Vallès - Barcelona | Spain |
| 1275.9.34001 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1275.9.34003 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1275.9.34004 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1275.9.34002 Boehringer Ingelheim Investigational Site | Seville | Spain |
| 1275.9.34010 Boehringer Ingelheim Investigational Site | Valencia | Spain |
| 1275.9.34006 Boehringer Ingelheim Investigational Site | Vic | Spain |
| 1275.9.88606 Boehringer Ingelheim Investigational Site | Kaohsiung City | Taiwan |
| 1275.9.88607 Boehringer Ingelheim Investigational Site | Kaohsiung City | Taiwan |
| 1275.9.88602 Boehringer Ingelheim Investigational Site | New Taipei City | Taiwan |
| 1275.9.88603 Boehringer Ingelheim Investigational Site | Taichung | Taiwan |
| 1275.9.88604 Boehringer Ingelheim Investigational Site | Taichung | Taiwan |
| 1275.9.88605 Boehringer Ingelheim Investigational Site | Tainan | Taiwan |
| Empagliflozin 10 mg |
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. |
| FG002 | Placebo | 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. |
| FG003 | Linagliptin 5 mg | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-Blind Period |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Empagliflozin 25 mg | 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. |
| BG001 | Empagliflozin 10 mg | 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. |
| BG002 | Placebo | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment | 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. | 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. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline and 24 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment. | Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication. | FAS (OC) | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline and 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment | Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication. | FAS (OC) | Posted | Least Squares Mean | Standard Error | kg | Baseline and 24 weeks |
|
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).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Empagliflozin 25 mg | 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. | 4 | 110 | 11 | 110 | ||
| EG001 | Empagliflozin 10 mg | 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. | 5 | 112 | 19 | 112 | ||
| EG002 | Placebo | 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. | 10 | 110 | 34 | 110 | ||
| EG003 | Linagliptin 5 mg | 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. | 18 | 606 | 78 | 606 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pharyngitis bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 17.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| C570240 | empagliflozin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
Not provided
Not provided
| Lack of Efficacy |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Not treated |
|
| Male |
|
| Superiority or Other (legacy) |
| 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). | Mixed Models Analysis | The unstructured covariance structure has been used to fit the mixed model. | <0.0001 | Mean Difference (Final Values) | -0.79 | Standard Error of the Mean | 0.12 | 95 | -1.02 | -0.55 | Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo. | Superiority or Other (legacy) |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|