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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01792518

Run by

Boehringer Ingelheim

People needed

360

Starts

2013-02-01

Expected to finish

2015-12-01

Last updated by the study team

2017-03-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Boehringer Ingelheim Investigational Site — Long Beach, California, United States
• Boehringer Ingelheim Investigational Site — North Hollywood, California, United States
• Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• Boehringer Ingelheim Investigational Site — Evansville, Indiana, United States
• Boehringer Ingelheim Investigational Site — Flint, Michigan, United States
• Boehringer Ingelheim Investigational Site — Jackson, Mississippi, United States
• Boehringer Ingelheim Investigational Site — Asheboro, North Carolina, United States
• Boehringer Ingelheim Investigational Site — Charlotte, North Carolina, United States
• Boehringer Ingelheim Investigational Site — Fargo, North Dakota, United States
• Boehringer Ingelheim Investigational Site — Columbus, Ohio, United States
• Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
• Boehringer Ingelheim Investigational Site — Knoxville, Tennessee, United States
• Boehringer Ingelheim Investigational Site — Houston, Texas, United States
• Boehringer Ingelheim Investigational Site — Edmonton, Alberta, Canada
• Boehringer Ingelheim Investigational Site — Victoria, British Columbia, Canada
• Boehringer Ingelheim Investigational Site — Mount Pearl, Newfoundland and Labrador, Canada
• Boehringer Ingelheim Investigational Site — London, Ontario, Canada
• Boehringer Ingelheim Investigational Site — Mississauga, Ontario, Canada
• Boehringer Ingelheim Investigational Site — Sarnia, Ontario, Canada
• Boehringer Ingelheim Investigational Site — Toronto, Ontario, Canada
• Boehringer Ingelheim Investigational Site — Waterloo, Ontario, Canada
• Boehringer Ingelheim Investigational Site — Gentofte Municipality, Denmark
• Boehringer Ingelheim Investigational Site — Hillerød, Denmark
• Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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