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 the
previous 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, a
dopamine-agonist, a bile-acid sequestrant a short acting (prandial) insulin or
premixed 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 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.

- Current treatment with systemic steroids (glucocorticoids) at time of informed
consent or 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 to
informed consent.