Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: BI 10773; Placebo; Placebo; Placebo; Placebo; Placebo; BI 10773; Placebo; Placebo; BI 10773; Placebo; Placebo; Placebo; BI 10773; BI 10773; BI 10773; Placebo; BI 10773; Placebo; Placebo; Placebo; Sitagliptin 100mg; BI 10773; Placebo; Placebo; Placebo; Placebo; Placebo; Placebo; Placebo
Intervention description: BI 10773 tablets once daily; Placebo matching BI 10773 low dose; Placebo matching BI 10773 high dose; Placebo matching Sitagliptin; Placebo matching BI 10773 high dose; Placebo matching BI 10773 high dose; BI 10773 tablets once daily; Placebo matching BI 10773 low dose; Placebo matching BI 10773 low dose; BI 10773 tablets once daily; Placebo matching BI 10773 low dose; Placebo matching BI 10773 high dose; Placebo matching Sitagliptin; BI 10773 tablets once daily; BI 10773 tablets once daily; BI 10773 tablets once daily; Placebo matching BI 10773 high dose; BI 10773 tablets once daily; Placebo matching BI 10773 low dose; Placebo matching BI 10773 high dose; Placebo matching Sitagliptin; Sitagliptin once daily; BI 10773 tablets once daily; Placebo matching BI 10773 low dose; Placebo matching BI 10773 low dose; Placebo matching BI 10773 low dose; Placebo matching BI 10773 high dose; Placebo matching BI 10773 low dose; Placebo matching BI 10773 high dose; Placebo matching BI 10773 high dose
Intervention MeSH terms: Sitagliptin Phosphate; Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 2705.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will investigate the efficacy and long term safety and tolerability of BI 10773 in
      type 2 diabetic patients.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients completing the entire treatment period of the preceding double-blind trial
             1245.19, 1245.20 or 1245.23 with or without rescue therapy.

          2. Signed and dated written informed consent by date of Visit 1 in accordance with Good
             Clinical Practice and local legislation.

        Exclusion criteria:

          1. Patient who meet one or more of the withdrawal criteria of the treatment period of the
             previous trial 1245.19, 1245.20 or 1245.23.

          2. Indication of liver disease, defined by serum levels of either alanine
             aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper
             limit of normal as determined during last visit of preceding trial.

          3. Impaired renal function defined as glomerular filtration rate<30 ml/min (severe renal
             impairment, Modification of Diet in Renal Disease formula) as determined during last
             visit of preceding trial.

          4. Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to
             local label, which started during trial participation in 1245.19, 1245.20 or 1245.23

          5. Pre-menopausal women (last menstruation < or = 1 year prior to informed consent) who
             are nursing or pregnant or are of child-bearing potential and are not practicing an
             acceptable method of birth control, or do not plan to continue using this method
             throughout the study and do not agree to submit to periodic pregnancy testing during
             participation in the trial. Acceptable methods of birth control include tubal
             ligation, transdermal patch, intra uterine devices/systems, oral, implantable or
             injectable contraceptives, sexual abstinence (if acceptable by local authorities),
             double barrier method and vasectomised partner.

          6. Alcohol or drug abuse within the 3 months prior to informed consent that would
             interfere with trial participation or any ongoing condition leading to a decreased
             compliance to study procedures or study drug intake.

          7. Participation in another trial with an investigational drug within 30 days prior to
             informed consent (except 1245.19, 1245.20 and 1245.23).

          8. Any other clinical condition that would jeopardize patient's safety while
             participating in this clinical trial.