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

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Placebo

Drug: Linagliptin 5mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01792518

2012-002603-17 (EudraCT Number)

1218.89

Details and patient eligibility

About

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.

Enrollment

360 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.