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
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; Placebo; Placebo; Placebo; Placebo; empagliflozin (low dose qd); Placebo; Placebo; Placebo; Placebo; Placebo; Placebo; Placebo; Placebo; Placebo; Placebo; Empagliflozin (high dose qd); empagliflozin (high dose bid); Placebo; empagliflozin (low dose bid)
Intervention description: Patients receive placebo matching empagliflozin (low dose qd); Patients receive placebo matching empagliflozin (low dose bid); Patients receive placebo matching Empagliflozin (high dose qd); Patients receive placebo matching Empagliflozin (high dose qd); Patients receive placebo matching Empagliflozin (high dose qd); Patients receive Empagliflozin low dose once daily; Patients receive placebo matching empagliflozin (low dose qd); Patients receive placebo matching empagliflozin (low dose bid); Patients receive placebo matching Empagliflozin (high dose bid); Patients receive placebo matching Empagliflozin (high dose bid); Patients receive placebo matching empagliflozin (low dose qd); Patients receive placebo matching empagliflozin (low dose bid); Patients receive placebo matching Empagliflozin (high dose bid); Patients receive placebo matching empagliflozin (low dose qd); Patients receive placebo matching empagliflozin (low dose bid); Patients receive placebo matching Empagliflozin (high dose bid); Patients receive Empagliflozin high dose once daily; Patients receive Empagliflozin high dose split twice daily; Patients receive placebo matching Empagliflozin (high dose qd); Patients receive Empagliflozin low dose split twice daily
Intervention MeSH terms: Empagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 983.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this study is to investigate the efficacy and safety of two doses (high and low)
      of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus
      (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a
      twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose
      once daily or split vs. low dose once daily or split). This is done to evaluate whether a
      twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once
      daily dosing when given on top of metformin background therapy.
    

Eligibility criteria:

        Inclusion criteria:

          1. confirmed diagnosis of T2DM

          2. Glycated hemoglobin (HbA1c) >=7.0 and <=10/0% at Visit 1

          3. Metformin therapy (at least 1500 mg/day, BID)

          4. age>=18 at Visit 1

          5. body mass index <=45 kg/m2

        Exclusion criteria:

          1. estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula)
             screening and/or run-in

          2. a confirmed glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during
             placebo run-in