Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01778049 | Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes | PHASE3 | COMPLETED | 708 | — | — | Jan 1, 2013 | Mar 1, 2015 | Apr 4, 2016 | 114 | United States, Argentina +9 |
| NCT01370005 | 12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus | PHASE3 | COMPLETED | 825 | — | — | Jun 1, 2011 | Jul 1, 2012 | Feb 22, 2016 | 120 | United States, Canada +10 |
| NCT01289990 | Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes | PHASE3 | COMPLETED | 2,705 | — | — | Feb 1, 2011 | May 1, 2013 | Jul 15, 2014 | 243 | United States, Belgium +17 |
| NCT01210001 | Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin | PHASE3 | COMPLETED | 499 | — | — | Sep 1, 2010 | - | Jun 17, 2014 | 68 | United States, Canada +5 |
| NCT01159600 | Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes | PHASE3 | COMPLETED | 1,504 | — | — | Jul 1, 2010 | - | Jun 17, 2014 | 148 | United States, Canada +10 |
| NCT01167881 | Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes | PHASE3 | COMPLETED | 1,549 | — | — | Aug 1, 2010 | Aug 1, 2015 | Sep 2, 2016 | 182 | United States, Argentina +21 |
| NCT01193218 | Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 547 | — | — | Sep 1, 2010 | Jun 1, 2012 | Jun 17, 2014 | 32 | Japan |
Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term "baseline" was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as "pre-treatment". Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference. Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial.
Change from baseline in HbA1c after 12 weeks of treatment.
Change from baseline of mean 24-hour systolic blood pressure (SBP).
Change from baseline in HbA1c after 52 weeks
Change from baseline in HbA1c after 76 weeks
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.
The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.
| Arm | Type | Description |
|---|---|---|
| Empagliflozin 10 mg dose | EXPERIMENTAL | Empagliflozin open label treatment period |
| Placebo add on 10 mg dose | EXPERIMENTAL | Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in |
| Empagliflozin/Linagliptin 25/5 mg Dose | EXPERIMENTAL | Empagliflozin / Linagliptin 25/5 mg Dose FDC active |
| Empagliflozin/Linagliptin 10/5 mg Dose. | EXPERIMENTAL | Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo |
| Empagliflozin/Linagliptin 10/5 mg Dose | EXPERIMENTAL | Empagliflozin / Linagliptin 10/5 mg Dose FDC active |
| Empagliflozin 25 mg dose | EXPERIMENTAL | Empagliflozin open label treatment period |
| Empagliflozin/Linagliptin 25/5 mg Dose. | EXPERIMENTAL | Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo |
| Placebo add on 25 mg dose | EXPERIMENTAL | Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in |
| BI 10773 low dose | EXPERIMENTAL | BI 10773 low dose once daily |
| BI 10773 high dose | EXPERIMENTAL | BI 10773 high dose once daily |
| Placebo | PLACEBO_COMPARATOR | Placebo tablets matching BI 10773 |
| BI 10773 low (drug naive) | EXPERIMENTAL | BI 10773 tablets once daily |
| BI 10773 high (drug naive) | EXPERIMENTAL | BI 10773 tablets once daily |
| Placebo (drug naive) | PLACEBO_COMPARATOR | Placebo tablets matching BI 10773 / Sitagliptin once daily |
| Sitagliptin 100mg (drug naive) | ACTIVE_COMPARATOR | Sitagliptin once daily |
| BI 10773 low (pioglitazone) | EXPERIMENTAL | BI 10773 tablets once daily |
| BI 10773 high (pioglitazone) | EXPERIMENTAL | BI 10773 tablets once daily |
| Placebo (pioglitazone) | PLACEBO_COMPARATOR | Placebo tablets matching BI 10773 once daily |
| BI 10773 low (metformin) | EXPERIMENTAL | BI 10773 tablets once daily |
| BI 10773 high (metformin) | EXPERIMENTAL | BI 10773 tablets once daily |
| Placebo (metformin) | PLACEBO_COMPARATOR | Placebo tablets matching BI 10773 once daily |
| BI 10773 low (metformin+sulfonylurea) | EXPERIMENTAL | BI 10773 tablets once daily |
| BI 10773 high (metformin+sulfonylurea) | EXPERIMENTAL | BI 10773 tablets once daily |
| Placebo (metformin+sulfonylurea) | PLACEBO_COMPARATOR | Placebo tablets matching BI 10773 |
| BI 10773 Arm 2 | EXPERIMENTAL | BI 10773 once daily high dose |
| BI 10773 open-label | EXPERIMENTAL | BI 10773 once daily high dose open label |
| BI 10773 Arm 1 | EXPERIMENTAL | BI 10773 once daily low dose |
| BI 10773 dose plus metformin | EXPERIMENTAL | Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily |
| Glimepiride 1-4 mg plus metformin | ACTIVE_COMPARATOR | Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily. |
| BI 10773 low dose QD | EXPERIMENTAL | BI 10773 tablets low dose once a day |
| BI 10773 mid-low dose QD | EXPERIMENTAL | BI 10773 tablets mid-low dose once a day |
| BI 10773 mid-high dose QD | EXPERIMENTAL | BI 10773 tablets mid-high dose once a day |
| BI 10773 high dose QD | EXPERIMENTAL | BI 10773 tablets high dose once a day |
| Name | Type | Description |
|---|---|---|
| BI 10773 | DRUG | Empagliflozin active |
| BI 10773 Placebo | DRUG | Empagliflozin placebo |
| BI 10773 / BI 1356 | DRUG | Empagliflozin / Linagliptin 25/5 mg Dose FDC active |
| BI 10773 / BI 1356 Placebo | DRUG | Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC |
| Placebo | DRUG | Placebo matching BI 10773 low dose |
| Sitagliptin 100mg | DRUG | Sitagliptin once daily |
| Placebo identical to BI 10773 high dose | DRUG | Placebo tablets matching BI 10773 high dose |
| Placebo identical to BI 10773 low dose | DRUG | Placebo tablets matching BI 10773 low dose |
| Glimepiride | DRUG | 1-4 mg once daily |
| Placebo (low dose) | DRUG | Placebo tablets once a day |
| Placebo (mid dose) | DRUG | Placebo tablets once a day |
| Placebo (high dose) | DRUG | Placebo tablets once a day |
Inclusion criteria: 1. Signed and dated ICF (Informed Consent Form) 2. Male or female on diet and exercise regime and on stable background metformin \> or equal to 1500 mg or maximun dose according to local label 3. HBA1c (Glicoslated Hemoglobin) \> or equal to 8% and \< or equal to 10.5 % at Visit...