BI 10773 add-on to Metformin in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: BI 10773; placebo; sitagliptin
Intervention MeSH terms: Sitagliptin Phosphate; Empagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Enrollment: 495.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The objective of the current study is to investigate the efficacy, safety and
      pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on
      therapy to on going metformin therapy in patients with T2DM with insufficient glycemic
      control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM)
      as add-on therapy to metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously
             treated with metformin alone or with metformin and one other oral antidiabetic drug

          2. Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum
             tolerated dose.

          3. HbA1c at screening 6.5% to 9.0% for patients on metformin and one other antidiabetic
             drug, and HbA1c >7.0% to 10% for patients on metformin only

          4. HbA1c >7.0% to 10.0% at Visit 2 (Start of Run-in)

          5. Age >=18 and <80years

          6. Body Mass Index (BMI) <=40 kg/m2

          7. Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice (GCP) and local legislation

        Exclusion Criteria:

          1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior
             to informed consent

          2. Impaired hepatic function

          3. Renal insufficiency or impaired renal function

          4. Diseases of the central nervous system or psychiatric disorders or clinically relevant
             neurological disorders that may interfere with participation in the trial

          5. Chronic or clinically relevant acute infections

          6. Current or chronic urogenital tract infection

          7. History of clinically relevant allergy/hypersensitivity

          8. Treatment with glitazones (e.g., rosiglitazone, pioglitazone), glucagon-like peptide
             (GLP-1) analogues, or insulin within 3 months prior to informed consent

          9. Treatment with anti-obesity drugs within 3 months prior to informed consent

         10. Treatment with systemic steroids or change in dosage of thyroid hormones within 6
             weeks prior to informed consent

         11. Alcohol abuse or drug abuse

         12. Treatment with an investigational drug within 2 months prior to informed consent

         13. Women of child-bearing potential who are nursing or pregnant, or who 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 periodic pregnancy testing during
             participation in the trial