Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients

Inclusion criteria

• Diagnosis of Type 2 diabetes mellitus(T2DM) prior to informed consent
• Male and female patients on diet and exercise regimen who are drug-naïve
• Glycosylated haemoglobin A1c (HbA1c) at V1a >/=7.5 %<11% for main group and HbA1c >/= 11.0 % for the additional parallel group
• Age >/= 18 and </= 80 years at Visit 1a (Screening)
• Body Mass Index(BMI)</ = 40 kg/m2 at Visit 1a (Screening)
• Signed and dated written informed consent by date of Visit 1a in accordance with good clinical practice(GCP) and local legislation

Exclusion criteria

• Uncontrolled hyperglycaemia required for rescue medication during placebo run-in phase
• In main group, the patients with investigational medicinal product(IMP) compliance < 80 % or >120 % during 2 weeks placebo run in period
• Acute coronary syndrome stroke or Transient ischaemic attack (TIA) within 3 months prior to randomisation
• 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
• Known hypersensitivity or allergy to linagliptin or its excipients or metformin or placebo
• Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening
• 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.
• Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form or during the trial.
• 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
• Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
• Renal failure or renal impairment at Visit 1a (screening) with an Estimated Glomerular Filtration Rate(eGFR) < 60 ml/min
• Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
• Dehydration by clinical judgement of the investigator
• Clinical detected unstable or acute congestive heart failure
• Acute or chronic metabolic acidosis (present in patient history)
• Hereditary galactose intolerance
• Known history of pancreatitis and chronic pancreatitis
• Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within last 5 years.
• Any other clinical condition that would jeopardize patients safety while participating in this clinical trial at the discretion of investigator