MARLINA - T2DM : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Boehringer Ingelheim
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01792518
First received: February 14, 2013
Last updated: October 17, 2014
Last verified: October 2014
  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
Endpoint Classification: Safety/Efficacy Study
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:
  • Change from baseline in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The time weighted average of percentage change from baseline in UACR [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 404
Study Start Date: February 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: October 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
Genders Eligible for Study:   Both
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 or insulin (except basal 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Hide Study Locations
Locations
United States, Alabama
1218.89.01010 Boehringer Ingelheim Investigational Site Recruiting
Birmingham, Alabama, United States
United States, California
1218.89.01020 Boehringer Ingelheim Investigational Site Not yet recruiting
Long Beach, California, United States
1218.89.01008 Boehringer Ingelheim Investigational Site Recruiting
North Hollywood, California, United States
United States, Colorado
1218.89.01011 Boehringer Ingelheim Investigational Site Recruiting
Denver, Colorado, United States
United States, Florida
1218.89.01018 Boehringer Ingelheim Investigational Site Not yet recruiting
Miami, Florida, United States
United States, Illinois
1218.89.01001 Boehringer Ingelheim Investigational Site Recruiting
Melrose Park, Illinois, United States
United States, Indiana
1218.89.01015 Boehringer Ingelheim Investigational Site Recruiting
Evansville, Indiana, United States
United States, Michigan
1218.89.01019 Boehringer Ingelheim Investigational Site Not yet recruiting
Flint, Michigan, United States
United States, Mississippi
1218.89.01005 Boehringer Ingelheim Investigational Site Recruiting
Jackson, Mississippi, United States
United States, North Carolina
1218.89.01004 Boehringer Ingelheim Investigational Site Recruiting
Asheboro, North Carolina, United States
1218.89.01017 Boehringer Ingelheim Investigational Site Recruiting
Charlotte, North Carolina, United States
United States, North Dakota
1218.89.01003 Boehringer Ingelheim Investigational Site Recruiting
Fargo, North Dakota, United States
United States, Ohio
1218.89.01002 Boehringer Ingelheim Investigational Site Recruiting
Columbus, Ohio, United States
United States, Oklahoma
1218.89.01013 Boehringer Ingelheim Investigational Site Recruiting
Oklahoma City, Oklahoma, United States
United States, Tennessee
1218.89.01016 Boehringer Ingelheim Investigational Site Recruiting
Knoxville, Tennessee, United States
Canada, Alberta
1218.89.11004 Boehringer Ingelheim Investigational Site Completed
Edmonton, Alberta, Canada
Canada, British Columbia
1218.89.11008 Boehringer Ingelheim Investigational Site Recruiting
Victoria, British Columbia, Canada
Canada, Newfoundland and Labrador
1218.89.11006 Boehringer Ingelheim Investigational Site Recruiting
Mount Pearl, Newfoundland and Labrador, Canada
Canada, Ontario
1218.89.11002 Boehringer Ingelheim Investigational Site Recruiting
London, Ontario, Canada
1218.89.11003 Boehringer Ingelheim Investigational Site Recruiting
Mississauga, Ontario, Canada
1218.89.11007 Boehringer Ingelheim Investigational Site Recruiting
Sarnia, Ontario, Canada
1218.89.11005 Boehringer Ingelheim Investigational Site Recruiting
Toronto, Ontario, Canada
1218.89.11009 Boehringer Ingelheim Investigational Site Recruiting
Waterloo, Ontario, Canada
Denmark
1218.89.45001 Boehringer Ingelheim Investigational Site Recruiting
Gentofte, Denmark
1218.89.45002 Boehringer Ingelheim Investigational Site Recruiting
Hillerød, Denmark
1218.89.45003 Boehringer Ingelheim Investigational Site Recruiting
Silkeborg, Denmark
1218.89.45004 Boehringer Ingelheim Investigational Site Recruiting
Slagelse, Denmark
Finland
1218.89.35803 Boehringer Ingelheim Investigational Site Recruiting
Kerava, Finland
1218.89.35804 Boehringer Ingelheim Investigational Site Recruiting
Oulu, Finland
1218.89.35801 Boehringer Ingelheim Investigational Site Recruiting
Tampere, Finland
1218.89.35802 Boehringer Ingelheim Investigational Site Recruiting
Turku, Finland
France
1218.89.33003 Boehringer Ingelheim Investigational Site Recruiting
Bersée, France
1218.89.33005 Boehringer Ingelheim Investigational Site Recruiting
Bourg des Comptes, France
1218.89.33007 Boehringer Ingelheim Investigational Site Recruiting
Grenoble Cedex 09, France
1218.89.33010 Boehringer Ingelheim Investigational Site Recruiting
Le Creusot, France
1218.89.33001 Boehringer Ingelheim Investigational Site Recruiting
Marseille cedex, France
1218.89.33008 Boehringer Ingelheim Investigational Site Recruiting
Saint Mandé cedex, France
1218.89.33004 Boehringer Ingelheim Investigational Site Recruiting
Vieux Condé, France
1218.89.33011 Boehringer Ingelheim Investigational Site Recruiting
Vénissieux Cedex, France
Germany
1218.89.49001 Boehringer Ingelheim Investigational Site Recruiting
Aschaffenburg, Germany
1218.89.49013 Boehringer Ingelheim Investigational Site Recruiting
Asslar, Germany
1218.89.49011 Boehringer Ingelheim Investigational Site Recruiting
Dresden, Germany
1218.89.49002 Boehringer Ingelheim Investigational Site Recruiting
Düsseldorf, Germany
1218.89.49012 Boehringer Ingelheim Investigational Site Recruiting
Flörsheim, Germany
1218.89.49005 Boehringer Ingelheim Investigational Site Recruiting
Münster, Germany
1218.89.49003 Boehringer Ingelheim Investigational Site Recruiting
Pirna, Germany
1218.89.49009 Boehringer Ingelheim Investigational Site Recruiting
Schweinfurt, Germany
Japan
1218.89.81001 Boehringer Ingelheim Investigational Site Completed
Aoba-ku,Sendai,Miyagi, Japan
1218.89.81004 Boehringer Ingelheim Investigational Site Completed
Chiyoda-ku,Tokyo, Japan
1218.89.81002 Boehringer Ingelheim Investigational Site Completed
Cyuo-ku,Tokyo, Japan
1218.89.81008 Boehringer Ingelheim Investigational Site Active, not recruiting
Kita-ku, Osaka, Osaka, Japan
1218.89.81005 Boehringer Ingelheim Investigational Site Completed
Shimizu-ku,Shizuoka city,Shizuoka, Japan
1218.89.81006 Boehringer Ingelheim Investigational Site Completed
Suita,Osaka, Japan
1218.89.81007 Boehringer Ingelheim Investigational Site Completed
Teine-ku,Sapporo,Hokkaido, Japan
Korea, Republic of
1218.89.82001 Boehringer Ingelheim Investigational Site Recruiting
Goyang, Korea, Republic of
1218.89.82002 Boehringer Ingelheim Investigational Site Recruiting
Goyang, Korea, Republic of
1218.89.82008 Boehringer Ingelheim Investigational Site Recruiting
Jinju, Korea, Republic of
1218.89.82006 Boehringer Ingelheim Investigational Site Recruiting
Seongnam, Korea, Republic of
1218.89.82005 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1218.89.82003 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1218.89.82009 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1218.89.82004 Boehringer Ingelheim Investigational Site Recruiting
Wonju, Korea, Republic of
Philippines
1218.89.63001 Boehringer Ingelheim Investigational Site Recruiting
Cebu City, Philippines, Philippines
1218.89.63002 Boehringer Ingelheim Investigational Site Recruiting
Cebu City, Philippines, Philippines
1218.89.63003 Boehringer Ingelheim Investigational Site Recruiting
Pasig City, Philippines, Philippines
1218.89.63004 Boehringer Ingelheim Investigational Site Recruiting
San Juan City, Philippines, Philippines
Spain
1218.89.34003 Boehringer Ingelheim Investigational Site Recruiting
Almeria, Spain
1218.89.34004 Boehringer Ingelheim Investigational Site Recruiting
L'Hospitalet de Llobregat, Spain
1218.89.34001 Boehringer Ingelheim Investigational Site Recruiting
Madrid, Spain
1218.89.34007 Boehringer Ingelheim Investigational Site Recruiting
Madrid, Spain
1218.89.34006 Boehringer Ingelheim Investigational Site Recruiting
Pozuelo de Alarcon, Spain
1218.89.34005 Boehringer Ingelheim Investigational Site Recruiting
San Sebastian de los Reyes, Spain
1218.89.34002 Boehringer Ingelheim Investigational Site Recruiting
Valencia, Spain
Taiwan
1218.89.88004 Boehringer Ingelheim Investigational Site Recruiting
Changhua, Taiwan
1218.89.88011 Boehringer Ingelheim Investigational Site Not yet recruiting
Chiayi, Taiwan
1218.89.88008 Boehringer Ingelheim Investigational Site Recruiting
Kaohsiung, Taiwan
1218.89.88003 Boehringer Ingelheim Investigational Site Recruiting
New Taipei, Taiwan
1218.89.88002 Boehringer Ingelheim Investigational Site Recruiting
New Taipei, Taiwan
1218.89.88010 Boehringer Ingelheim Investigational Site Recruiting
Taichung, Taiwan
1218.89.88005 Boehringer Ingelheim Investigational Site Recruiting
Taichung, Taiwan
1218.89.88006 Boehringer Ingelheim Investigational Site Recruiting
Tainan, Taiwan
1218.89.88001 Boehringer Ingelheim Investigational Site Recruiting
Taipei, Taiwan
1218.89.88009 Boehringer Ingelheim Investigational Site Recruiting
Taipei, Taiwan
Vietnam
1218.89.84002 Boehringer Ingelheim Investigational Site Recruiting
Hanoi, Vietnam, Vietnam
1218.89.84006 Boehringer Ingelheim Investigational Site Recruiting
Hanoi, Vietnam, Vietnam
1218.89.84001 Boehringer Ingelheim Investigational Site Recruiting
Hanoi, Vietnam, Vietnam
1218.89.84005 Boehringer Ingelheim Investigational Site Recruiting
Ho Chi Minh City, Vietnam
1218.89.84004 Boehringer Ingelheim Investigational Site Recruiting
Ho Chi Minh City, Vietnam
1218.89.84003 Boehringer Ingelheim Investigational Site Recruiting
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01792518     History of Changes
Other Study ID Numbers: 1218.89, 2012-002603-17
Study First Received: February 14, 2013
Last Updated: October 17, 2014
Health Authority: Canada: Health Canada
Denmark: The Danish Health and Medicines Authority
Finland: Finnish Medicines Agency
France: Agence Nationale sécurité médicament et des produits santé
Germany: Federal Institute for Drugs and Medical Devices
Japan: Ministry of Health, Labor and Welfare
Philippines: Department of Health
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Taiwan : Food and Drug Administration
United States: Food and Drug Administration
Vietnam: Ministry of Health

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

ClinicalTrials.gov processed this record on October 29, 2014