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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016243-20 | EudraCT Number | EudraCT |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 10773 low dose | Experimental | Patients receive BI 10773 low dose tablets once daily |
|
| BI 10773 high dose | Experimental | Patients receive BI 10773 high dose tablets once daily |
|
| Placebo | Placebo Comparator | Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin |
|
| Sitagliptin 100 mg | Active Comparator | Patients receive Sitagliptin 100 mg tablets once daily |
|
| BI 10773 high dose open label | Experimental | Patients receive BI 10773 high dose tablets open label once daily |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo identical to BI10773 high dose | Drug | placebo tablets once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks | The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive. | Baseline and day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 24 in Body Weight | The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive. | Baseline and day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Hypoglycaemic Adverse Events | Confirmed hypoglycaemic events refer to all hypoglycaemic events, that had a glucose value <= 70 ml/dL or where assistance was required. Symptomatic hypoglycaemic events were to be reported as adverse events. Patients can be counted in more than one category. | From first drug intake until 7 days after last medication intake, up to 219 days |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1245.20.10124 Boehringer Ingelheim Investigational Site | Mesa | Arizona | United States | |||
| 1245.20.10108 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38770818 | Derived | Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2. | |
| 35472672 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning. |
| FG001 | Empagliflozin10 mg | Patients receive 10 mg Empagliflozin in tablets once daily in the morning. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
| BI 10773 |
| Drug |
BI 10773 low dose tablet once daily |
|
| BI 10773 open label | Drug | Patients receive BI 10773 high dose tablets open label once daily |
|
| Placebo identical to BI10773 low dose | Drug | placebo tablets once daily |
|
| Placebo identical to BI10773 low dose | Drug | placebo tablets once daily |
|
| Placebo identical to BI10773 high dose | Drug | placebo tablets once daily |
|
| Placebo identical to Sitagliptin 100mg | Drug | placebo tablets once daily |
|
| Placebo identical to Sitagliptin 100mg | Drug | placebo tablets once daily |
|
| BI10773 | Drug | BI 10773 high dose tablets once daily |
|
| Sitagliptin | Drug | Sitagliptin tablets 100 mg once daily |
|
| Placebo identical to Sitagliptin 100mg | Drug | placebo tablets once daily |
|
| Placebo identical to BI10773 low dose | Drug | placebo tablets once daily |
|
| Placebo identical to BI10773 high dose | Drug | placebo tablets once daily |
|
| Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP) | The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive. For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored. | Baseline and week 24 |
| Phoenix |
| Arizona |
| United States |
| 1245.20.10150 Boehringer Ingelheim Investigational Site | Hot Springs | Arkansas | United States |
| 1245.20.10154 Boehringer Ingelheim Investigational Site | Chino | California | United States |
| 1245.20.10009 Boehringer Ingelheim Investigational Site | Santa Ana | California | United States |
| 1245.20.10131 Boehringer Ingelheim Investigational Site | West Hills | California | United States |
| 1245.20.10038 Boehringer Ingelheim Investigational Site | Northglenn | Colorado | United States |
| 1245.20.10137 Boehringer Ingelheim Investigational Site | Clearwater | Florida | United States |
| 1245.20.10006 Boehringer Ingelheim Investigational Site | Miami | Florida | United States |
| 1245.20.10085 Boehringer Ingelheim Investigational Site | Plantation | Florida | United States |
| 1245.20.10078 Boehringer Ingelheim Investigational Site | Tampa | Florida | United States |
| 1245.20.10080 Boehringer Ingelheim Investigational Site | Decatur | Georgia | United States |
| 1245.20.10128 Boehringer Ingelheim Investigational Site | Avon | Indiana | United States |
| 1245.20.10060 Boehringer Ingelheim Investigational Site | Fishers | Indiana | United States |
| 1245.20.10065 Boehringer Ingelheim Investigational Site | Indianapolis | Indiana | United States |
| 1245.20.10117 Boehringer Ingelheim Investigational Site | Arkansas City | Kansas | United States |
| 1245.20.10039 Boehringer Ingelheim Investigational Site | Wichita | Kansas | United States |
| 1245.20.10146 Boehringer Ingelheim Investigational Site | Louisville | Kentucky | United States |
| 1245.20.10144 Boehringer Ingelheim Investigational Site | Watertown | Massachusetts | United States |
| 1245.20.10115 Boehringer Ingelheim Investigational Site | Brick | New Jersey | United States |
| 1245.20.10129 Boehringer Ingelheim Investigational Site | Carlisle | Ohio | United States |
| 1245.20.10045 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States |
| 1245.20.10119 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States |
| 1245.20.10130 Boehringer Ingelheim Investigational Site | Gallipolis | Ohio | United States |
| 1245.20.10089 Boehringer Ingelheim Investigational Site | Houston | Texas | United States |
| 1245.20.10151 Boehringer Ingelheim Investigational Site | Hurst | Texas | United States |
| 1245.20.10155 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States |
| 1245.20.32008 Boehringer Ingelheim Investigational Site | Brussels | Belgium |
| 1245.20.32011 Boehringer Ingelheim Investigational Site | Brussels | Belgium |
| 1245.20.32023 Boehringer Ingelheim Investigational Site | Brussels | Belgium |
| 1245.20.32003 Boehringer Ingelheim Investigational Site | De Pinte | Belgium |
| 1245.20.32015 Boehringer Ingelheim Investigational Site | Deurne | Belgium |
| 1245.20.32016 Boehringer Ingelheim Investigational Site | Deurne | Belgium |
| 1245.20.32025 Boehringer Ingelheim Investigational Site | Gozée | Belgium |
| 1245.20.32022 Boehringer Ingelheim Investigational Site | Landen | Belgium |
| 1245.20.32019 Boehringer Ingelheim Investigational Site | Leopoldsburg | Belgium |
| 1245.20.32024 Boehringer Ingelheim Investigational Site | Linkebeek | Belgium |
| 1245.20.32021 Boehringer Ingelheim Investigational Site | Mouscron | Belgium |
| 1245.20.32027 Boehringer Ingelheim Investigational Site | Retie | Belgium |
| 1245.20.32020 Boehringer Ingelheim Investigational Site | Sint-Gillis-Waas | Belgium |
| 1245.20.32018 Boehringer Ingelheim Investigational Site | Tielt | Belgium |
| 1245.20.32026 Boehringer Ingelheim Investigational Site | Tremelo | Belgium |
| 1245.20.20011 Boehringer Ingelheim Investigational Site | Chilliwack | British Columbia | Canada |
| 1245.20.20018 Boehringer Ingelheim Investigational Site | Victoria | British Columbia | Canada |
| 1245.20.20015 Boehringer Ingelheim Investigational Site | Winnipeg | Manitoba | Canada |
| 1245.20.20012 Boehringer Ingelheim Investigational Site | Moncton | New Brunswick | Canada |
| 1245.20.20016 Boehringer Ingelheim Investigational Site | Mount Pearl | Newfoundland and Labrador | Canada |
| 1245.20.20008 Boehringer Ingelheim Investigational Site | St. John's | Newfoundland and Labrador | Canada |
| 1245.20.20001 Boehringer Ingelheim Investigational Site | Barrie | Ontario | Canada |
| 1245.20.20019 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada |
| 1245.20.20010 Boehringer Ingelheim Investigational Site | London | Ontario | Canada |
| 1245.20.20017 Boehringer Ingelheim Investigational Site | London | Ontario | Canada |
| 1245.20.20003 Boehringer Ingelheim Investigational Site | Markham | Ontario | Canada |
| 1245.20.20009 Boehringer Ingelheim Investigational Site | Newmarket | Ontario | Canada |
| 1245.20.20013 Boehringer Ingelheim Investigational Site | Ottawa | Ontario | Canada |
| 1245.20.20005 Boehringer Ingelheim Investigational Site | Strathroy | Ontario | Canada |
| 1245.20.20002 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1245.20.20006 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1245.20.20014 Boehringer Ingelheim Investigational Site | Charlottetown | Prince Edward Island | Canada |
| 1245.20.20007 Boehringer Ingelheim Investigational Site | Montague | Prince Edward Island | Canada |
| 1245.20.20021 Boehringer Ingelheim Investigational Site | Trois-Rivières | Quebec | Canada |
| 1245.20.86007 Boehringer Ingelheim Investigational Site | Beijing | China |
| 1245.20.86008 Boehringer Ingelheim Investigational Site | Beijing | China |
| 1245.20.86001 Boehringer Ingelheim Investigational Site | Guangzhou | China |
| 1245.20.86002 Boehringer Ingelheim Investigational Site | Guangzhou | China |
| 1245.20.86003 Boehringer Ingelheim Investigational Site | Guangzhou | China |
| 1245.20.86012 Boehringer Ingelheim Investigational Site | Guiyang | China |
| 1245.20.86020 Boehringer Ingelheim Investigational Site | Hangzhou | China |
| 1245.20.86049 Boehringer Ingelheim Investigational Site | Jinan | China |
| 1245.20.86018 Boehringer Ingelheim Investigational Site | Jingzhou | China |
| 1245.20.86019 Boehringer Ingelheim Investigational Site | Nanchang | China |
| 1245.20.86010 Boehringer Ingelheim Investigational Site | Nanjing | China |
| 1245.20.86043 Boehringer Ingelheim Investigational Site | Nanjing | China |
| 1245.20.86016 Boehringer Ingelheim Investigational Site | Qingdao | China |
| 1245.20.86004 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1245.20.86005 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1245.20.86006 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1245.20.86057 Boehringer Ingelheim Investigational Site | Shenyang | China |
| 1245.20.86017 Boehringer Ingelheim Investigational Site | Shiyan | China |
| 1245.20.86013 Boehringer Ingelheim Investigational Site | Suzhou | China |
| 1245.20.86015 Boehringer Ingelheim Investigational Site | Taiyuan | China |
| 1245.20.86009 Boehringer Ingelheim Investigational Site | Wuhan | China |
| 1245.20.86011 Boehringer Ingelheim Investigational Site | Xi'an | China |
| 1245.20.86014 Boehringer Ingelheim Investigational Site | Xiamen | China |
| 1245.20.49013 Boehringer Ingelheim Investigational Site | Dresden | Germany |
| 1245.20.49016 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany |
| 1245.20.49015 Boehringer Ingelheim Investigational Site | Frankfurt | Germany |
| 1245.20.49019 Boehringer Ingelheim Investigational Site | Haag | Germany |
| 1245.20.49020 Boehringer Ingelheim Investigational Site | Hohenmölsen | Germany |
| 1245.20.49014 Boehringer Ingelheim Investigational Site | Köthen | Germany |
| 1245.20.49002 Boehringer Ingelheim Investigational Site | Neuwied | Germany |
| 1245.20.49008 Boehringer Ingelheim Investigational Site | Nuremberg | Germany |
| 1245.20.49017 Boehringer Ingelheim Investigational Site | Saint Ingbert/Oberwürzbach | Germany |
| 1245.20.49022 Boehringer Ingelheim Investigational Site | Schauenburg | Germany |
| 1245.20.49003 Boehringer Ingelheim Investigational Site | Unterschneidheim | Germany |
| 1245.20.91005 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1245.20.91006 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1245.20.91008 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1245.20.91003 Boehringer Ingelheim Investigational Site | Belagavi | India |
| 1245.20.91004 Boehringer Ingelheim Investigational Site | Chennai | India |
| 1245.20.91009 Boehringer Ingelheim Investigational Site | Chennai | India |
| 1245.20.91002 Boehringer Ingelheim Investigational Site | Mumbai | India |
| 1245.20.91007 Boehringer Ingelheim Investigational Site | Mumbai, Maharastra | India |
| 1245.20.91010 Boehringer Ingelheim Investigational Site | Nagpur | India |
| 1245.20.91001 Boehringer Ingelheim Investigational Site | Tamil Nadu | India |
| 1245.20.35302 Boehringer Ingelheim Investigational Site | Co. Cork | Ireland |
| 1245.20.35305 Boehringer Ingelheim Investigational Site | Co. Galway | Ireland |
| 1245.20.35303 Boehringer Ingelheim Investigational Site | Co. Wexford | Ireland |
| 1245.20.35304 Boehringer Ingelheim Investigational Site | Offaly | Ireland |
| 1245.20.35306 Boehringer Ingelheim Investigational Site | Wexford | Ireland |
| 1245.20.81007 Boehringer Ingelheim Investigational Site | Chiyoda-ku, Tokyo | Japan |
| 1245.20.81001 Boehringer Ingelheim Investigational Site | Chuo-ku, Tokyo | Japan |
| 1245.20.81002 Boehringer Ingelheim Investigational Site | Chuo-ku, Tokyo | Japan |
| 1245.20.81005 Boehringer Ingelheim Investigational Site | Ebetsu, Hokkaido | Japan |
| 1245.20.81004 Boehringer Ingelheim Investigational Site | Kamakura, Kanagawa | Japan |
| 1245.20.81003 Boehringer Ingelheim Investigational Site | Minato-ku, Tokyo | Japan |
| 1245.20.81006 Boehringer Ingelheim Investigational Site | Shinjuku-ku, Tokyo | Japan |
| 1245.20.81008 Boehringer Ingelheim Investigational Site | Shinjuku-ku, Tokyo | Japan |
| 1245.20.81009 Boehringer Ingelheim Investigational Site | Suita, Osaka | Japan |
| 1245.20.81010 Boehringer Ingelheim Investigational Site | Ube, Yamaguchi | Japan |
| 1245.20.81012 Boehringer Ingelheim Investigational Site | Urasoe, Okinawa | Japan |
| 1245.20.81013 Boehringer Ingelheim Investigational Site | Urasoe, Okinawa | Japan |
| 1245.20.41004 Boehringer Ingelheim Investigational Site | Lugano | Switzerland |
| 1245.20.41003 Boehringer Ingelheim Investigational Site | Rorschach | Switzerland |
| Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034. |
| 27316632 | Derived | Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17. |
| 24622369 | Derived | Roden M, Weng J, Eilbracht J, Delafont B, Kim G, Woerle HJ, Broedl UC; EMPA-REG MONO trial investigators. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):208-19. doi: 10.1016/S2213-8587(13)70084-6. Epub 2013 Sep 9. |
| FG002 | Empagliflozin 25 mg | Patients receive 25 mg Empagliflozin in tablets once daily in the morning. |
| FG003 | Sitagliptin 100 mg | Patients receive 100 mg Sitagliptin in tablets once daily in the morning. |
| FG004 | Empagliflozin 25 mg OL | Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) including all randomised and treated patients who had a baseline HbA1c value (non-open label groups) and Open-label set including all patients entered in the empagliflozin 25 mg open-label treatment arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning. |
| BG001 | Empagliflozin10 mg | Patients receive 10 mg Empagliflozin in tablets once daily in the morning. |
| BG002 | Empagliflozin 25 mg | Patients receive 25 mg Empagliflozin in tablets once daily in the morning. |
| BG003 | Sitagliptin 100 | Patients receive 100 mg Sitagliptin in tablets once daily in the morning. |
| BG004 | Empagliflozin 25 mg OL | Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning. |
| BG005 | 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 | The descriptive statistics for Total refers to the 4 non-open label groups (Placebo, Empagliflozin 10mg and 25 mg, Sitagliptin) | 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 | Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks | The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive. | FAS and open-label set, last observation carried forward (LOCF) was used as the imputation rule for both sets | Posted | Mean | Standard Error | percent of HbA1c | Baseline and day 169 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 24 in Body Weight | The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive. | FAS (LOCF) and open-label set (LOCF) | Posted | Mean | Standard Error | kg | Baseline and day 169 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP) | The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive. For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored. | FAS and open-label set, last observation carried forward without values following a change in antihypertensive therapy (LOCF- H) was used as the imputation rule | Posted | Mean | Standard Error | mmHg | Baseline and week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirmed Hypoglycaemic Adverse Events | Confirmed hypoglycaemic events refer to all hypoglycaemic events, that had a glucose value <= 70 ml/dL or where assistance was required. Symptomatic hypoglycaemic events were to be reported as adverse events. Patients can be counted in more than one category. | Treated set (actual) including all patients treated with at least 1 dose of randomised trial medication with some treatment switchers (1 from Empa25 to placebo; 1 patient got Empa 10 at least with one mis-allocated kit) and open-label set | Posted | Number | percentage of participants | From first drug intake until 7 days after last medication intake, up to 219 days |
|
From first drug administration until seven days after last trial medication intake, up to 219 days
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 | Placebo | Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning. | 6 | 229 | 63 | 229 | ||
| EG001 | Empagliflozin10 mg | Patients receive 10 mg Empagliflozin in tablets once daily in the morning. | 8 | 224 | 45 | 224 | ||
| EG002 | Empagliflozin 25 mg | Patients receive 25 mg Empagliflozin in tablets once daily in the morning. | 5 | 223 | 36 | 223 | ||
| EG003 | Sitagliptin 100 mg | Patients receive 100 mg Sitagliptin in tablets once daily in the morning. | 6 | 223 | 44 | 223 | ||
| EG004 | Empagliflozin 25 mg OL | Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning. | 3 | 87 | 27 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes virus infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Gilbert's syndrome | Congenital, familial and genetic disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hernia | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 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 |
|---|---|
| C570240 | empagliflozin |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
Not provided
Not provided
| Male |
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Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, and baseline HbA1c as linear covariate |
| ANCOVA |
| <0.0001 |
Difference calculated as empagliflozin 25mg minus placebo |
| Mean Difference (Final Values) |
| -0.85 |
| Standard Error of the Mean |
| 0.07 |
| 2-Sided |
| 97.5 |
| -1.01 |
| -0.69 |
| No |
| Superiority or Other |
| OG004 | Empagliflozin 25 mg OL | Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning. |
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| OG003 | Sitagliptin 100 mg | Patients receive 100 mg Sitagliptin in tablets once daily in the morning. |
| OG004 | Empagliflozin 25 mg OL | Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning. |
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|
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| Sitagliptin 100 mg |
Patients receive 100 mg Sitagliptin in tablets once daily in the morning. |
| OG004 | Empagliflozin 25 mg OL | Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning. |
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