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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01792518
First received: February 14, 2013
Last updated: January 13, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: Linagliptin 5mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.


Enrollment: 360
Study Start Date: February 2013
Study Completion Date: December 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: linagliptin 5mg
linagliptin 5 mg once daily
Drug: Linagliptin 5mg
Placebo Comparator: placebo
matching placebo for linagliptin dose once daily
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01792518

  Hide Study Locations
Locations
United States, Alabama
Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
United States, California
Boehringer Ingelheim Investigational Site
Long Beach, California, United States
Boehringer Ingelheim Investigational Site
North Hollywood, California, United States
United States, Colorado
Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
United States, Florida
Boehringer Ingelheim Investigational Site
Miami, Florida, United States
United States, Indiana
Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
United States, Michigan
Boehringer Ingelheim Investigational Site
Flint, Michigan, United States
United States, Mississippi
Boehringer Ingelheim Investigational Site
Jackson, Mississippi, United States
United States, North Carolina
Boehringer Ingelheim Investigational Site
Asheboro, North Carolina, United States
Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
United States, North Dakota
Boehringer Ingelheim Investigational Site
Fargo, North Dakota, United States
United States, Ohio
Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
United States, Oklahoma
Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, Tennessee
Boehringer Ingelheim Investigational Site
Knoxville, Tennessee, United States
United States, Texas
Boehringer Ingelheim Investigational Site
Houston, Texas, United States
Canada, Alberta
Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
Canada, British Columbia
Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
Canada, Newfoundland and Labrador
Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada
Canada, Ontario
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Sarnia, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
Denmark
Boehringer Ingelheim Investigational Site
Gentofte, Denmark
Boehringer Ingelheim Investigational Site
Hillerød, Denmark
Boehringer Ingelheim Investigational Site
Silkeborg, Denmark
Boehringer Ingelheim Investigational Site
Slagelse, Denmark
Finland
Boehringer Ingelheim Investigational Site
Kerava, Finland
Boehringer Ingelheim Investigational Site
Oulu, Finland
Boehringer Ingelheim Investigational Site
Tampere, Finland
Boehringer Ingelheim Investigational Site
Turku, Finland
France
Boehringer Ingelheim Investigational Site
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
Germany
Boehringer Ingelheim Investigational Site
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
Japan
Boehringer Ingelheim Investigational Site
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
Korea, Republic of
Boehringer Ingelheim Investigational Site
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
Philippines
Boehringer Ingelheim Investigational Site
Cebu City, Philippines, Philippines
Boehringer Ingelheim Investigational Site
Pasig City, Philippines, Philippines
Boehringer Ingelheim Investigational Site
San Juan City, Philippines, Philippines
Spain
Boehringer Ingelheim Investigational Site
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
Taiwan
Boehringer Ingelheim Investigational Site
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
Vietnam
Boehringer Ingelheim Investigational Site
Hanoi, Vietnam, Vietnam
Boehringer Ingelheim Investigational Site
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01792518     History of Changes
Other Study ID Numbers: 1218.89
2012-002603-17 ( EudraCT Number: EudraCT )
Study First Received: February 14, 2013
Results First Received: November 8, 2016
Last Updated: January 13, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Albuminuria
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Proteinuria
Urination Disorders
Urological Manifestations
Signs and Symptoms
Angiotensin Receptor Antagonists
Linagliptin
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 28, 2017