Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: linagliptin; linagliptin
Intervention description: Patients receive linagliptin 5 mg tablets once daily; Patients receive linagliptin 5 mg tablets once daily
Intervention MeSH terms: Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 701.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The objective of the current study is to investigate the efficacy, safety and tolerability of
      BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to
      metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
    

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 not more than one other oral
             antidiabetic drug

          2. Diagnosis of type 2 diabetes prior to informed consent

          3. Glycosylated haemoglobin A1 (HbA1c)at screening:

             For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients
             not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%

          4. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in

          5. Age 18 -80 years

          6. BMI (Body Mass Index) less than 40 kg/m2

          7. Signed and dated written informed consent by date of Visit 1a in accordance with 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. Known hypersensitivity or allergy to the investigational product or its excipients or
             metformin or placebo

          4. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent

          5. Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to
             informed consent

          6. Treatment with insulin within 3 months prior to informed consent

          7. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3
             months prior to informed consent

          8. Alcohol abuse within the 3 months prior to informed consent that would interfere with
             trial participation or drug abuse

          9. Participation in another trial with an investigational drug within 2 months prior to
             informed consent

         10. Pre-menopausal women 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.

         11. Current treatment with systemic steroids at time of informed consent or change in
             dosage of thyroid hormones within 6 weeks prior to informed consent.

         12. Renal failure or renal impairment

         13. Unstable or acute congestive heart failure

         14. Acute or chronic metabolic acidosis (present in patient history)

         15. Hereditary galactose intolerance