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

A Phase IIIb, Multicenter, Multinational, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Glycemic and Renal Efficacy of Once Daily Administration of Linagliptin 5 mg for 24 Weeks in Type 2 Diabetes Patients, With Micro- or Macroalbuminuria (30-3000mg/g Creatinine) on Top of Current Treatment With Angiotensin ConvEnzyme Inhibitor or Angiotensin Receptor Blocker - MARLINA (Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin)

Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24 weeks of treatment.

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.