Intervention: Linagliptin
Trial phase: Phase 3
ATC code: A10BD11 | A10BD19 | A10BD27 | A10BH05
SMILES: CC#CCn1c(N2CCC[C@@H](N)C2)nc2c1c(=O)n(Cc1nc(C)c3ccccc3n1)c(=O)n2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 200
Group description: Linagliptin 5mg, once daily tablets, oral
Eligibility criteria:
Inclusion criteria:

Male and female patients with a diagnosis of type 2 diabetes mellitus, either treatment naive or treated with one antidiabetic medication. Antidiabetic therapy has to be unchanged for 6 weeks prior to the informed consent
Diagnosis of type 2 diabetes prior to informed consent

Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening):

For patients undergoing wash out of previous medication: HbA1c =7.0to =9.5% For patients not undergoing wash-out of previous medication: HbA1c =7.0 to =10.0%

Glycosylated haemoglobin A1 (HbA1c) =7.0 to =10.0% at Visit 2 (Start of Run-in)
Age = 18 and < 80 years at Visit 1a (Screening)
BMI (Body Mass Index) = 45 kg/m2 at Visit 1a (Screening)
Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

Exclusion criteria:

Myocardial infarction, stroke or TIA within 6 months prior to informed consent
Impaired hepatic function, defined by serum levels of either Alanine transaminase(SGPT), Aspartate transaminase(SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1a
Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during wash-out / placebo run-in and confirmed by a second measurement (not on the same day)
Known hypersensitivity or allergy to the investigational product or its excipients
Treatment with more than one antidiabetic drug within 6 weeks prior to informed consent
Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
Treatment with Glucagon-like peptide 1(GLP-1) analogues (e.g. exenatide) , Dipeptidyl-Peptidase 4(DPP-IV) inhibitor within 3 months prior to informed consent
Treatment with insulin within 3 months prior to informed consent
Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
Participation in another trial with an investigational drug within 2 months prior to informed consent

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 and do not agree to submit to periodic pregnancy testing during 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.
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 (serum creatinine =1.5 mg/dl as determined at Visit 1a)
Dehydration by clinical judgement of the investigator
Unstable or acute congestive heart failure
Acute or chronic metabolic acidosis (present in patient history)
Hereditary galactose intolerance