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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016154-40 | EudraCT Number | EudraCT |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients in order to provide these data for approval for BI 10773 by regulatory authorities as an antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 10773 low dose | Experimental | BI 10773 tablets once daily |
|
| BI 10773 high dose | Experimental | BI 10773 tablets once daily |
|
| Placebo | Placebo Comparator | Placebo tablets matching BI 10773 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo tablets matching BI 10773 low dose |
| |
| BI 10773 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline | Change From Baseline in HbA1c after 24 weeks. Note that adjusted means are provided. | Baseline and 24 weeks |
| HbA1c Change From Baseline for Pio and Met Background Medication Patients | Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only. Note that adjusted means are provided. | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose (FPG) Change From Baseline | Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment. Note that adjusted means are provided. | Baseline and 24 weeks |
| Body Weight Change From Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycaemic Events | Number of patients with hypoglycaemic events, as reported as adverse events. | From first drug administration until 7 days after last intake of study drug, up to 256 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 |
|---|---|---|---|---|---|---|
| 1245.19.10056 Boehringer Ingelheim Investigational Site | Muscle Shoals | Alabama | United States | |||
| 1245.19.10162 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 |
Not provided
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks |
| FG001 | Empa 10mg | Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
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Not provided
Not provided
| Drug |
BI 10773 tablets once daily |
|
| Placebo | Drug | Placebo tablets matching BI 10773 high dose |
|
| Placebo | Drug | Placebo tablets matching BI 10773 high dose |
|
| Placebo | Drug | Placebo tablets matching BI 10773 high dose |
|
| BI 10773 | Drug | BI 10773 tablets once daily |
|
Change from baseline in body weight after 24 weeks.
Note that adjusted means are provided.
| Baseline and 24 weeks |
| Glendale |
| Arizona |
| United States |
| 1245.19.10161 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | United States |
| 1245.19.10046 Boehringer Ingelheim Investigational Site | Tempe | Arizona | United States |
| 1245.19.10070 Boehringer Ingelheim Investigational Site | Irvine | California | United States |
| 1245.19.10047 Boehringer Ingelheim Investigational Site | La Mesa | California | United States |
| 1245.19.10149 Boehringer Ingelheim Investigational Site | Rancho Cucamonga | California | United States |
| 1245.19.10163 Boehringer Ingelheim Investigational Site | Riverside | California | United States |
| 1245.19.10131 Boehringer Ingelheim Investigational Site | West Hills | California | United States |
| 1245.19.10141 Boehringer Ingelheim Investigational Site | Milford | Connecticut | United States |
| 1245.19.10133 Boehringer Ingelheim Investigational Site | Jupiter | Florida | United States |
| 1245.19.10085 Boehringer Ingelheim Investigational Site | Plantation | Florida | United States |
| 1245.19.10077 Boehringer Ingelheim Investigational Site | Perry | Georgia | United States |
| 1245.19.10014 Boehringer Ingelheim Investigational Site | Dubuque | Iowa | United States |
| 1245.19.10160 Boehringer Ingelheim Investigational Site | Essex | Maryland | United States |
| 1245.19.10003 Boehringer Ingelheim Investigational Site | Dearborn | Michigan | United States |
| 1245.19.10059 Boehringer Ingelheim Investigational Site | New Hyde Park | New York | United States |
| 1245.19.10123 Boehringer Ingelheim Investigational Site | Smithtown | New York | United States |
| 1245.19.10071 Boehringer Ingelheim Investigational Site | Asheboro | North Carolina | United States |
| 1245.19.10086 Boehringer Ingelheim Investigational Site | Salisbury | North Carolina | United States |
| 1245.19.10008 Boehringer Ingelheim Investigational Site | Marion | Ohio | United States |
| 1245.19.10033 Boehringer Ingelheim Investigational Site | Chattanooga | Tennessee | United States |
| 1245.19.10112 Boehringer Ingelheim Investigational Site | Memphis | Tennessee | United States |
| 1245.19.10002 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | United States |
| 1245.19.20047 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada |
| 1245.19.20062 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada |
| 1245.19.20012 G.A. Research Associates Ltd. | Moncton | New Brunswick | Canada |
| 1245.19.20031 Boehringer Ingelheim Investigational Site | St. John's | Newfoundland and Labrador | Canada |
| 1245.19.20057 Boehringer Ingelheim Investigational Site | Brampton | Ontario | Canada |
| 1245.19.20059 Boehringer Ingelheim Investigational Site | Fort Erie | Ontario | Canada |
| 1245.19.20060 Boehringer Ingelheim Investigational Site | London | Ontario | Canada |
| 1245.19.20009 Boehringer Ingelheim Investigational Site | Newmarket | Ontario | Canada |
| 1245.19.20034 Boehringer Ingelheim Investigational Site | Sarnia | Ontario | Canada |
| 1245.19.20058 Boehringer Ingelheim Investigational Site | Saint Romuald | Quebec | Canada |
| 1245.19.20041 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada |
| 1245.19.30002 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1245.19.30001 Boehringer Ingelheim Investigational Site | Nikaia | Greece |
| 1245.19.30004 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece |
| 1245.19.91005 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1245.19.91006 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1245.19.91008 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1245.19.91003 Boehringer Ingelheim Investigational Site | Belagavi | India |
| 1245.19.91004 Boehringer Ingelheim Investigational Site | Chennai | India |
| 1245.19.91009 Boehringer Ingelheim Investigational Site | Chennai | India |
| 1245.19.91001 Boehringer Ingelheim Investigational Site | Coimbatore | India |
| 1245.19.91015 Boehringer Ingelheim Investigational Site | Kalaburagi | India |
| 1245.19.91011 Boehringer Ingelheim Investigational Site | Kartanaka | India |
| 1245.19.91002 Boehringer Ingelheim Investigational Site | Mumbai | India |
| 1245.19.91007 Boehringer Ingelheim Investigational Site | Mumbai, Maharastra | India |
| 1245.19.91017 Boehringer Ingelheim Investigational Site | Mysore | India |
| 1245.19.91010 Boehringer Ingelheim Investigational Site | Nagpur | India |
| 1245.19.91012 Boehringer Ingelheim Investigational Site | New Delhi | India |
| 1245.19.91013 Boehringer Ingelheim Investigational Site | Patna | India |
| 1245.19.91014 Boehringer Ingelheim Investigational Site | Pune | India |
| 1245.19.91016 Boehringer Ingelheim Investigational Site | Pune | India |
| 1245.19.63002 Boehringer Ingelheim Investigational Site | Cebu City, N/A, Philippines | Philippines |
| 1245.19.63003 Boehringer Ingelheim Investigational Site | Davao City, N/A, Philippines | Philippines |
| 1245.19.63004 Boehringer Ingelheim Investigational Site | Manila, Philippines | Philippines |
| 1245.19.63005 Boehringer Ingelheim Investigational Site | Pasig City, Philippines | Philippines |
| 1245.19.63001 Boehringer Ingelheim Investigational Site | San Juan City, Philippines | Philippines |
| 1245.19.66003 Boehringer Ingelheim Investigational Site | Saimai | Thailand |
| 1245.19.66004 Boehringer Ingelheim Investigational Site | Udon Thani, Thailand | Thailand |
| 1245.19.75002 Boehringer Ingelheim Investigational Site | Dnipro | Ukraine |
| 1245.19.75001 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1245.19.75005 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1245.19.75006 Boehringer Ingelheim Investigational Site | Lviv | Ukraine |
| 1245.19.75004 Boehringer Ingelheim Investigational Site | Vinnitsa | Ukraine |
| 1245.19.75003 Boehringer Ingelheim Investigational Site | Vinnytsia | Ukraine |
| 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. |
| 26138864 | Derived | Kovacs CS, Seshiah V, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Stella P, Woerle HJ, Broedl UC; EMPA-REG EXTEND PIO investigators. Empagliflozin as Add-on Therapy to Pioglitazone With or Without Metformin in Patients With Type 2 Diabetes Mellitus. Clin Ther. 2015 Aug;37(8):1773-88.e1. doi: 10.1016/j.clinthera.2015.05.511. Epub 2015 Jun 29. |
| FG002 | Empa 25mg | Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated set (TS): all patients treated with at least one dose of randomised study medication
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks |
| BG001 | Empa 10mg | Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks |
| BG002 | Empa 25mg | Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks |
| 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 | Change From Baseline in HbA1c after 24 weeks. Note that adjusted means are provided. | Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values. | Posted | Mean | Standard Error | percentage of HbA1c | Baseline and 24 weeks |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Plasma Glucose (FPG) Change From Baseline | Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment. Note that adjusted means are provided. | Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values. | Posted | Mean | Standard Error | mg/dL | Baseline and 24 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Body Weight Change From Baseline | Change from baseline in body weight after 24 weeks. Note that adjusted means are provided. | Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values. | Posted | Mean | Standard Error | kg | Baseline and 24 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | HbA1c Change From Baseline for Pio and Met Background Medication Patients | Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only. Note that adjusted means are provided. | Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value for patients on pioglitazone and metformin background medication. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values. | Posted | Mean | Standard Error | percentage of HbA1c | Baseline and 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Hypoglycaemic Events | Number of patients with hypoglycaemic events, as reported as adverse events. | Treated set which included all patients treated with at least one dose of randomised study medication | Posted | Number | percentage of participants | From first drug administration until 7 days after last intake of study drug, up to 256 days |
|
|
From first dose of randomised study medication until 7 days after the last dose, up to 256 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 | A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks | 7 | 165 | 56 | 165 | ||
| EG001 | Empa 10mg | Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks | 7 | 165 | 50 | 165 | ||
| EG002 | Empa 25mg | Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks | 6 | 168 | 34 | 168 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Oesophageal rupture | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Amoebic colitis | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MEDDRA 15.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MEDDRA 15.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MEDDRA 15.0 | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MEDDRA 15.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MEDDRA 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 15.0 | Systematic Assessment |
| |
| Brain stem infarction | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MEDDRA 15.0 | 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 |
Not provided
Not provided
Not provided
| Male |
|
| ANCOVA | Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c. | <0.0001 | Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in HbA1c was the first step in each hierarchical sequence. | Mean Difference (Final Values) | -0.61 | Standard Error of the Mean | 0.09 | 2-Sided | 97.5 | -0.82 | -0.40 | Difference calculated as empa 25mg minus placebo | No | Superiority or Other |
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| Units |
|---|
| Counts |
|---|
| Participants |
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|