Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: linagliptin2.5mg/metformin1000mg; linagliptin2.5mg/metformin1000mg; linagliptin 5mg; Metformin 500mg; linagliptin2.5mg/metformin500mg; linagliptin2.5mg/metformin500mg; linagliptin 5mg; Metformin 1000mg
Intervention description: linagliptin2.5mg/metformin1000mg BID; linagliptin2.5mg/metformin1000mg BID; linagliptin 5mg once daily; Metformin 500mg BID; linagliptin2.5mg/metformin500mg BID; linagliptin2.5mg/metformin500mg BID; linagliptin 5mg once daily; Metformin 1000mg BID
Intervention MeSH terms: Metformin; Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Enrollment: 876.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Reduced factorial design study with 24 week randomized treatment of initial combination
      therapy with linagliptin and metformin in T2DM patients
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of Type 2 diabetes mellitus(T2DM) prior to informed consent

          2. Male and female patients on diet and exercise regimen who are drug-naïve

          3. Glycosylated haemoglobin A1c (HbA1c) at V1a >/=7.5 %<11% for main group and HbA1c >/=
             11.0 % for the additional parallel group

          4. Age >/= 18 and </= 80 years at Visit 1a (Screening)

          5. Body Mass Index(BMI)</ = 40 kg/m2 at Visit 1a (Screening)

          6. Signed and dated written informed consent by date of Visit 1a in accordance with good
             clinical practice(GCP) and local legislation

        Exclusion criteria:

          1. Uncontrolled hyperglycaemia required for rescue medication during placebo run-in phase

          2. In main group, the patients with investigational medicinal product(IMP) compliance <
             80 % or >120 % during 2 weeks placebo run in period

          3. Acute coronary syndrome stroke or Transient ischaemic attack (TIA) within 3 months
             prior to randomisation

          4. Impaired hepatic function, defined by serum levels of either Alanine
             aminotransferase(ALT) ,Aspartate aminotransferase(AST), or alkaline phosphatase (AP)
             above 3 x upper limit of normal (ULN) ,or total bilirubin above 1.5 x ULN as
             determined at Visit 1a

          5. Known hypersensitivity or allergy to linagliptin or its excipients or metformin or
             placebo

          6. Treatment with anti-obesity drugs 3 months prior to informed consent or any other
             treatment at the time of screening

          7. 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 in the opinion of the
             investigator.

          8. Concurrent participation in another clinical trial or any investigational therapy
             within thirty days prior to signing the consent form or during the trial.

          9. Pre-menopausal women (last menstruation </= 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

         10. Current treatment with systemic steroids at time of informed consent or change in
             dosage of thyroid hormones within 6 weeks prior to informed consent.

         11. Renal failure or renal impairment at Visit 1a (screening) with an Estimated Glomerular
             Filtration Rate(eGFR) < 60 ml/min

         12. Bariatric surgery within the past two years and other gastrointestinal surgeries that
             induce chronic malabsorption

         13. Dehydration by clinical judgement of the investigator

         14. Clinical detected unstable or acute congestive heart failure

         15. Acute or chronic metabolic acidosis (present in patient history)

         16. Hereditary galactose intolerance

         17. Known history of pancreatitis and chronic pancreatitis

         18. Medical history of cancer (except for basal cell carcinoma) and/or treatment for
             cancer within last 5 years.

         19. Any other clinical condition that would jeopardize patients safety while participating
             in this clinical trial at the discretion of investigator