BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: linagliptin; placebo
Intervention description: active; placebo to linagliptin 5 mg
Intervention MeSH terms: Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1058.0
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 combination with a sulphonylurea 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, currently
             treated only with a stable total daily dose of preferably* >/= 1500 mg metformin and a
             dose of a sulphonylurea drug that has been documented, by the Investigator, to be the
             individual maximum tolerated dose of that sulphonylurea drug. Both the dose and dosing
             regimen of metformin and the sulphonylurea must be stable (i.e. unchanged) for 10
             weeks prior to informed consent, and must not be changed for the duration of the trial

          2. Glycosylated haemoglobin A1 (HbA1c) >/= 7.0 and </= 10.0% at the screening Visit 1a
             and at Visit 2 (start of placebo run-in phase)

          3. Age >/= 18 and </= 80 years at Visit 1a (screening)

          4. BMI (Body Mass Index) </= 40 kg/m2 at Visit 1a (screening)

          5. Signed and dated written informed consent, at the latest by the date of Visit 1a, in
             accordance with GCP and local legislation *Patients currently treated with a total
             daily dose of less than 1500 mg metformin can be included in the trial if the
             Investigator has documented that the dose is the maximum tolerated dose of metformin
             for that patient.

        Exclusion criteria:

          1. Myocardial infarction, stroke or TIA (transient ischaemic attack) within 6 months
             prior to the date of informed consent

          2. Impaired hepatic function, defined by serum levels of either alanine transaminase
             (ALT/SGPT), aspartase transaminase (AST/SGOT), or alkaline phosphatase (ALP) above 3
             times the upper limit of normal (ULN), as determined at Visit 1a

          3. Renal failure or renal impairment (serum creatinine >/= 1.5 mg/dl) as determined at
             Visit 1a

          4. Treatment with rosiglitazone or pioglitazone within 3 months prior to the date of
             informed consent

          5. Treatment with GLP-1 analogues (e.g. exenatide) within 3 months prior to the date of
             informed consent

          6. Treatment with insulin within 3 months prior to the date of informed consent

          7. Treatment with anti-obesity drugs (e.g. sibutramine, rimonabant, orlistat) within 3
             months prior to the date of informed consent

          8. Current treatment with systemic steroids (i.e. at the time of informed consent) or a
             change in the dosage of thyroid hormones within 6 weeks prior to the date of informed
             consent

          9. Pre-menopausal women (last menstruation </= 1 year prior to the date of 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 periodic pregnancy testing during their participation in the
                  trial. Acceptable methods of birth control include transdermal patch, intra
                  uterine devices/systems (IUDs/IUSs), oral, implantable or injectable
                  contraceptives, sexual abstinence and vasectomised partner. No exception will be
                  made.

         10. Known hypersensitivity or allergy to the investigational product or its excipients or
             to the trial background therapy (i.e. metformin in combination with a sulphonylurea)
             or sulphonamides

         11. Dehydration (as confirmed by the Investigators clinical opinion)

         12. Current acute or chronic metabolic acidosis