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

NCT ID: NCT01792518

Last Updated: 2017-03-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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linagliptin 5mg

linagliptin 5 mg once daily

Group Type EXPERIMENTAL

Linagliptin 5mg

Intervention Type DRUG

placebo

matching placebo for linagliptin dose once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Placebo

Intervention Type DRUG

Linagliptin 5mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

Boehringer Ingelheim Investigational Site

Long Beach, California, United States

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Boehringer Ingelheim Investigational Site

North Hollywood, California, United States

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Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

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Boehringer Ingelheim Investigational Site

Miami, Florida, United States

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Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

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Boehringer Ingelheim Investigational Site

Flint, Michigan, United States

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Boehringer Ingelheim Investigational Site

Jackson, Mississippi, United States

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Boehringer Ingelheim Investigational Site

Asheboro, North Carolina, United States

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Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

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Boehringer Ingelheim Investigational Site

Fargo, North Dakota, United States

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Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

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Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

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Boehringer Ingelheim Investigational Site

Knoxville, Tennessee, United States

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Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

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Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

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Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada

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Boehringer Ingelheim Investigational Site

London, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Waterloo, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Gentofte Municipality, , Denmark

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Boehringer Ingelheim Investigational Site

Hillerød, , Denmark

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Boehringer Ingelheim Investigational Site

Silkeborg, , Denmark

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Boehringer Ingelheim Investigational Site

Slagelse, , Denmark

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Boehringer Ingelheim Investigational Site

Kerava, , Finland

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Oulu, , Finland

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Tampere, , Finland

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Turku, , Finland

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Bersée, , France

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Bourg-des-Comptes, , France

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Grenoble, , France

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Le Creusot, , France

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Marseille, , France

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Boehringer Ingelheim Investigational Site

Saint-Mandé, , France

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Boehringer Ingelheim Investigational Site

Vénissieux, , France

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Vieux-Condé, , France

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Aschaffenburg, , Germany

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Aßlar, , Germany

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Dresden, , Germany

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Boehringer Ingelheim Investigational Site

Düsseldorf, , Germany

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Boehringer Ingelheim Investigational Site

Flörsheim, , Germany

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Boehringer Ingelheim Investigational Site

Pirna, , Germany

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Boehringer Ingelheim Investigational Site

Schweinfurt, , Germany

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Boehringer Ingelheim Investigational Site

Aoba-ku,Sendai,Miyagi, , Japan

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Boehringer Ingelheim Investigational Site

Chiyoda-ku,Tokyo, , Japan

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Boehringer Ingelheim Investigational Site

Cyuo-ku,Tokyo, , Japan

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Boehringer Ingelheim Investigational Site

Kita-ku, Osaka, Osaka, , Japan

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Boehringer Ingelheim Investigational Site

Shimizu-ku,Shizuoka city,Shizuoka, , Japan

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Boehringer Ingelheim Investigational Site

Suita,Osaka, , Japan

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Boehringer Ingelheim Investigational Site

Teine-ku,Sapporo,Hokkaido, , Japan

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Boehringer Ingelheim Investigational Site

Cebu City, Philippines, , Philippines

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Boehringer Ingelheim Investigational Site

Pasig City, Philippines, , Philippines

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Boehringer Ingelheim Investigational Site

San Juan City, Philippines, , Philippines

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Boehringer Ingelheim Investigational Site

Goyang, , South Korea

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Boehringer Ingelheim Investigational Site

Jinju, , South Korea

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Boehringer Ingelheim Investigational Site

Seongnam, , South Korea

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Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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Boehringer Ingelheim Investigational Site

Wŏnju, , South Korea

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Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, , Spain

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Madrid, , Spain

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Pozuelo de Alarcón, , Spain

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Boehringer Ingelheim Investigational Site

San Sebastián de los Reyes, , Spain

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Boehringer Ingelheim Investigational Site

Valencia, , Spain

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Boehringer Ingelheim Investigational Site

Changhua, , Taiwan

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Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

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Boehringer Ingelheim Investigational Site

New Taipei City, , Taiwan

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Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

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Boehringer Ingelheim Investigational Site

Tainan City, , Taiwan

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Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

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Boehringer Ingelheim Investigational Site

Hanoi, Vietnam, , Vietnam

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Boehringer Ingelheim Investigational Site

Ho Chi Minh City, , Vietnam

Site Status

Countries

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United States Canada Denmark Finland France Germany Japan Philippines South Korea Spain Taiwan Vietnam

References

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Siwy J, Klein T, Rosler M, von Eynatten M. Urinary Proteomics as a Tool to Identify Kidney Responders to Dipeptidyl Peptidase-4 Inhibition: A Hypothesis-Generating Analysis from the MARLINA-T2D Trial. Proteomics Clin Appl. 2019 Mar;13(2):e1800144. doi: 10.1002/prca.201800144. Epub 2019 Jan 28.

Reference Type DERIVED
PMID: 30632692 (View on PubMed)

Groop PH, Cooper ME, Perkovic V, Hocher B, Kanasaki K, Haneda M, Schernthaner G, Sharma K, Stanton RC, Toto R, Cescutti J, Gordat M, Meinicke T, Koitka-Weber A, Thiemann S, von Eynatten M. Linagliptin and its effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: the randomized MARLINA-T2D trial. Diabetes Obes Metab. 2017 Nov;19(11):1610-1619. doi: 10.1111/dom.13041. Epub 2017 Jul 31.

Reference Type DERIVED
PMID: 28636754 (View on PubMed)

Groop PH, Cooper ME, Perkovic V, Sharma K, Schernthaner G, Haneda M, Hocher B, Gordat M, Cescutti J, Woerle HJ, von Eynatten M. Dipeptidyl peptidase-4 inhibition with linagliptin and effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: Rationale and design of the MARLINA-T2D trial. Diab Vasc Dis Res. 2015 Nov;12(6):455-62. doi: 10.1177/1479164115579002. Epub 2015 Jul 28.

Reference Type DERIVED
PMID: 26224765 (View on PubMed)

Other Identifiers

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2012-002603-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1218.89

Identifier Type: -

Identifier Source: org_study_id

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