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

January 13, 2017 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Boehringer Ingelheim Investigational Site
    • British Columbia
      • Victoria, British Columbia, Canada
        • Boehringer Ingelheim Investigational Site
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada
        • Boehringer Ingelheim Investigational Site
    • Ontario
      • 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
  • Denmark
      • Gentofte, Denmark
        • Boehringer Ingelheim Investigational Site
      • Hillerød, Denmark
        • Boehringer Ingelheim Investigational Site
      • Silkeborg, Denmark
        • Boehringer Ingelheim Investigational Site
      • Slagelse, Denmark
        • Boehringer Ingelheim Investigational Site
  • Finland
      • Kerava, Finland
        • Boehringer Ingelheim Investigational Site
      • Oulu, Finland
        • Boehringer Ingelheim Investigational Site
      • Tampere, Finland
        • Boehringer Ingelheim Investigational Site
      • Turku, Finland
        • Boehringer Ingelheim Investigational Site
  • France
      • Bersée, France
        • Boehringer Ingelheim Investigational Site
      • Bourg des Comptes, France
        • Boehringer Ingelheim Investigational Site
      • Grenoble Cedex 09, France
        • Boehringer Ingelheim Investigational Site
      • Le Creusot, France
        • Boehringer Ingelheim Investigational Site
      • Marseille cedex, France
        • Boehringer Ingelheim Investigational Site
      • Saint Mandé cedex, France
        • Boehringer Ingelheim Investigational Site
      • Vieux Condé, France
        • Boehringer Ingelheim Investigational Site
      • Vénissieux Cedex, France
        • Boehringer Ingelheim Investigational Site
  • Germany
      • Aschaffenburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Asslar, Germany
        • Boehringer Ingelheim Investigational Site
      • Dresden, Germany
        • Boehringer Ingelheim Investigational Site
      • Düsseldorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Flörsheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Pirna, Germany
        • Boehringer Ingelheim Investigational Site
      • Schweinfurt, Germany
        • Boehringer Ingelheim Investigational Site
  • Japan
      • Aoba-ku,Sendai,Miyagi, Japan
        • Boehringer Ingelheim Investigational Site
      • Chiyoda-ku,Tokyo, Japan
        • Boehringer Ingelheim Investigational Site
      • Cyuo-ku,Tokyo, Japan
        • Boehringer Ingelheim Investigational Site
      • Kita-ku, Osaka, Osaka, Japan
        • Boehringer Ingelheim Investigational Site
      • Shimizu-ku,Shizuoka city,Shizuoka, Japan
        • Boehringer Ingelheim Investigational Site
      • Suita,Osaka, Japan
        • Boehringer Ingelheim Investigational Site
      • Teine-ku,Sapporo,Hokkaido, Japan
        • Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Goyang, Korea, Republic of
        • Boehringer Ingelheim Investigational Site
      • Jinju, Korea, Republic of
        • Boehringer Ingelheim Investigational Site
      • Seongnam, Korea, Republic of
        • Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • Boehringer Ingelheim Investigational Site
      • Wonju, Korea, Republic of
        • Boehringer Ingelheim Investigational Site
  • Philippines
      • Cebu City, Philippines, Philippines
        • Boehringer Ingelheim Investigational Site
      • Pasig City, Philippines, Philippines
        • Boehringer Ingelheim Investigational Site
      • San Juan City, Philippines, Philippines
        • Boehringer Ingelheim Investigational Site
  • Spain
      • L'Hospitalet de Llobregat, Spain
        • Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • Boehringer Ingelheim Investigational Site
      • Pozuelo de Alarcon, Spain
        • Boehringer Ingelheim Investigational Site
      • San Sebastian de los Reyes, Spain
        • Boehringer Ingelheim Investigational Site
      • Valencia, Spain
        • Boehringer Ingelheim Investigational Site
  • Taiwan
      • Changhua, Taiwan
        • Boehringer Ingelheim Investigational Site
      • Kaohsiung, Taiwan
        • Boehringer Ingelheim Investigational Site
      • New Taipei, Taiwan
        • Boehringer Ingelheim Investigational Site
      • Taichung, Taiwan
        • Boehringer Ingelheim Investigational Site
      • Tainan, Taiwan
        • Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Boehringer Ingelheim Investigational Site
    • California
      • Long Beach, California, United States
        • Boehringer Ingelheim Investigational Site
      • North Hollywood, California, United States
        • Boehringer Ingelheim Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • Boehringer Ingelheim Investigational Site
    • Florida
      • Miami, Florida, United States
        • Boehringer Ingelheim Investigational Site
    • Indiana
      • Evansville, Indiana, United States
        • Boehringer Ingelheim Investigational Site
    • Michigan
      • Flint, Michigan, United States
        • Boehringer Ingelheim Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States
        • Boehringer Ingelheim Investigational Site
    • North Carolina
      • Asheboro, North Carolina, United States
        • Boehringer Ingelheim Investigational Site
      • Charlotte, North Carolina, United States
        • Boehringer Ingelheim Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States
        • Boehringer Ingelheim Investigational Site
    • Ohio
      • Columbus, Ohio, United States
        • Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Boehringer Ingelheim Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States
        • Boehringer Ingelheim Investigational Site
    • Texas
      • Houston, Texas, United States
        • Boehringer Ingelheim Investigational Site
  • Vietnam
      • Hanoi, Vietnam, Vietnam
        • Boehringer Ingelheim Investigational Site
      • Ho Chi Minh City, Vietnam
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: linagliptin 5mg
linagliptin 5 mg once daily
Drug: Linagliptin 5mg
Placebo Comparator: placebo
matching placebo for linagliptin dose once daily
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment
Time Frame: Baseline and 24 weeks
Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double- blind trial medication. The term "baseline" refers to the last observation before the start of any randomised trial treatment. The number of participants analysed displays the number of participants with available data at the timepoint of interest.
Baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment
Time Frame: Baseline and 24 weeks
The time weighted average of percentage change from baseline in UACR (mg/g creatinine) during the course of 24 weeks of treatment. The term "baseline" for UACR refers to the geometric mean of UACR values measured at Visits 2 and 3. The number of participants analysed displays the number of participants with available data at the timepoint of interest. The Least Squares Means are adjusted geometric means.
Baseline and 24 weeks
The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment
Time Frame: Baseline and 24 weeks
The change from baseline in estimated glomerular filtration rate (eGFR) as assessed by chronic kidney disease epidemiology collaboration (CKD-EPI) equation (cystatin C) after 24 weeks of treatment. The term "baseline" refers to the last observation before the start of any randomised trial treatment. The number of participants analysed displays the number of participants with available data at the timepoint of interest. This outcome measure is a secondary safety endpoint.
Baseline and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 14, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.89
  • 2012-002603-17 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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