MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin

Inclusion criteria:

• Diagnosis of type 2 diabetes mellitus

• Glycosylated Hemoglobin (HbA1c) between 6.5 and 10% (inclusive)

• Current therapy with ACEi or ARB at stable dose for 10 weeks

• Urinary albumin-to-creatinine ratio (UACR): 30-3000 mg/g creatinine documented in theprevious 12 months or detected at Screening.

• Estimated Glomerular Filtration Rate (eGFR) greater than 30 ml/min.

• Age between 18 and 80 years.

Exclusion criteria:

• Dual or triple blockade of the Renin Angiotensin System (RAS)

• Uncontrolled hyperglycaemia

• Mean arterial blood pressure > 110 mmHg

• Known hypersensitivity or allergy to the investigational product, or their excipients (including matching placebos).

• Treatment with a glitazone within 6 months prior to informed consent.

• Treatment with a DiPeptidyl-Peptidase 4 (DPP-4) inhibitor, a Glucagon Like Peptide-1 (GLP-1) agonist, a Sodium/Glucose coTransporter 2 (SGLT2) inhibitor, adopamine-agonist, a bile-acid sequestrant a short acting (prandial) insulin orpremixed insulin within 10 weeks prior to informed consent.

• Treatment with anti-obesity drugs 10 weeks prior to informed consent.

• Alcohol or drug abuse within 3 months prior to informed consent that would interferewith trial participation or any ongoing condition leading to a decreased compliance tostudy procedures or study drug intake in the opinion of the investigator.

• Current treatment with systemic steroids (glucocorticoids) at time of informed consentor change in dosage of thyroid hormones within 6 weeks prior to informed consent.

• Participation in another trial with an investigational drug within 2 months prior toinformed consent.