Phase 2 N=659 Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension
Diabetes Mellitus, Type 2
Primary: Hypoglycaemic Events — 0.9; 1.8; 7.1; 2.4 percentage of participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=547 Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Primary: Change From Baseline in HbA1c After 12 Weeks of Treatment. — 0.30; -0.42; -0.40; -0.65 percentage of HbA1c — p=<0.0001
Phase 3 N=275 Empagliflozin Add on to Linagliptin Study in Japanese Patient With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Primary: Change of Glycosylated Haemoglobin A1c (Glycosylated Haemoglobin A1c After 24 Weeks of Double-blind Treatment From Baseline) — -0.93; 0.21 Percentage (%) — p=<0.0001
N/A N=31,908 Characteristics of Empagliflozin Initiators
Type 2 Diabetes
Primary: Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK — 5.45; 1.76; 1.44; 3.03…
Phase 2 N=75 Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days
Diabetes Mellitus, Type 1
Primary: Change From Baseline in 24 h UGE (g/24 h) After Seven Days of Treatment With Empagliflozin 2.5 mg, 10 mg, or 25 mg, or Placebo — -3.56; 72.45; 103.33; 101.79 g/24h…
Phase 3 N=1,160 Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Primary: Number of Patients With Drug Related Adverse Events — 19; 25; 13; 13 participants
Phase 3 N=709 Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes
Diabetes Mellitus, Type 2
Primary: Change From Baseline of HbA1c After 24 Weeks of Treatment. — -0.53; -0.21; -0.58; -0.10 Percentage of HbA1c — p=0.0013
Phase 3 N=7,028 BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).
Diabetes Mellitus, Type 2
Primary: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal…
Phase 3 N=1,363 Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
Diabetes Mellitus, Type 2
Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients — -1.19; -1.08; -0.62; -0.66 % change from baseline — p=<0.0001
Phase 3 N=606 Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes
Diabetes Mellitus, Type 2
Primary: HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment — -0.56; -0.65; 0.14 Percentage of HbA1c — p=<0.0001
Phase 3 N=977 Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
Diabetes Mellitus, Type 1
Primary: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]) — 0.20; -0.09; -0.25; -0.33 Percentage (%) — p=<0.0001
Phase 3 N=1,549 Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes
Diabetes Mellitus, Type 2
Primary: The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. — -0.66; -0.55 percentage of HbA1c — p=<0.0001
Phase 3 N=986 Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes
Diabetes Mellitus, Type 2
Primary: Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks — 0.06; -0.66; -0.77; -0.65 percent of HbA1c — p=<0.0001
Phase 3 N=730 Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
Diabetes Mellitus, Type 1
Primary: Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 — 0.09; -0.44; -0.44 Percentage (%) — p=<0.0001
Phase 3 N=499 Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin
Diabetes Mellitus, Type 2
Primary: HbA1c Change From Baseline — -0.11; -0.59; -0.72 percentage of HbA1c — p=<0.0001
Phase 2 N=52 Safety and Efficacy of Empagliflozin (BI 10773) in Type 1 Diabetes Mellitus Patients With or Without Renal Hyperfiltration
Diabetes Mellitus, Type 1
Primary: Change in Glomerular Filtration Rate (GFR) After 8 Weeks of Treatment With Empagliflozin Under Controlled Conditions of Euglycaemia and Hyperglycaemia — -19.6; -33.4…
Phase 2 N=80 Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure
Heart Failure Acute · Heart Failure，Congestive · Heart Failure; With Decompensation
Primary: Dyspnea — 1264; 1650 mmxh — p=0.18
Phase 3 N=2,705 Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes
Diabetes Mellitus, Type 2
Primary: Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment — -0.70; -0.82; 0.09; -0.58 % of HbA1c — p=<0.0001
Phase 2 N=37 Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls
Diabetes Mellitus, Type 2 · Healthy
Primary: Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14) — -321.7; -256.9 (milligram / minute/…
Phase 3 N=879 Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Primary: Change in Glycated Haemoglobin A1c (HbA1c) (%) From Baseline After 24 Weeks of Treatment — -0.94; -0.12; -0.91; -0.33 Percentage (%) — p=<0.0001
N/A N=3,431 Emp-Activity: Empagliflozin Functional Capacity
Heart Failure
Primary: Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice — 14.66; 17.61; 16.47…
Phase 2 N=31 Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study
Diabetes Mellitus, Type 1 · Diabetes Mellitus, Type 2 · Obesity
Primary: Glomerular Filtration Rate (GFR) Under Euglycaemic Conditions After 4 Weeks of Treatment With Either Empagliflozin Added to Ramipril or Placebo Added to Ramipril…
Phase 2 N=983 A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy
Diabetes Mellitus, Type 2
Primary: HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16 — -0.83; -0.72; -0.66; -0.64 percentage of HbA1c — p=<0.0001
Phase 2 N=48 Empa Add on to Insulin in Japanese Patient With Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1
Primary: Change From Baseline in 24 Hour UGE on Day 7 — -0.46; 64.63; 80.73; 97.64 gram per 24 hours (g/24 h) — p=<0.0001
Phase 3 N=1,479 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
Diabetes Mellitus, Type 2
Primary: HbA1c Change From Baseline — -0.13; -0.70; -0.77; -2.78 percentage of HbA1c — p=<0.0001
Phase 3 N=166 Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
Type 2 Diabetes Mellitus
Primary: Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo) — -0.55; 0.12 A1C Percentage
N/A N=344,995 Empa PASS on Urinary Tract Malignancies
Diabetes Mellitus, Type 2
Primary: Occurrence of Urinary Tract Cancer — 0.73; 1.07; 1.34; 1.52 Events per 1000 patient years — p=0.122
Phase 3 N=741 Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment
Diabetes Mellitus, Type 2 · Renal Insufficiency
Primary: HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment — 0.05; -0.46 percentage of HbA1c — p=<0.0001
N/A N=24,465 A Study Based on Data From German Sick Funds That Looks at the Costs of Treatment of Type-2 Diabetic Patients With Empagliflozin vs. DPP-4 Inhibitors vs. GLP-1 Receptor Agonists
Diabetes Mellitus, Type 2
Primary: Direct Healthcare Cost — 4247; 7009; 4319; 6535 Euro / patient-year — p=< 0.001
N/A N=333,580 Post-authorisation Safety Study in Patients With Type 2 Diabetes to Assess the Risk of Liver Injury, Kidney Injury, Urinary Tract and Genital Infections, and Diabetic Ketoacidosis in Patients Treated With Empagliflozin, Compared to DPP-4 Inhibitors
Diabetes Mellitus, Type 2
Primary: Incidence Rates of Acute Liver Injury (ALI) in Patients With no Predisposing Conditions (ALI1) in Propensity Score-trimmed Cohort for ALI1 — 0.60; 1.21; 1.09; NA Events…