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

Diabetes Mellitus, Type 2 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792518
• Other study ID #: 1218.89
• Secondary ID: 2012-002603-17
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2013
• Last updated: January 6, 2016
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaDenmark: The Danish Health and Medicines AuthorityFinland: Finnish Medicines AgencyFrance: Agence Nationale sécurité médicament et des produits santéGermany: Federal Institute for Drugs and Medical DevicesJapan: Ministry of Health, Labor and WelfarePhilippines: Department of HealthSouth Korea: Ministry of Food and Drug Safety (MFDS)Spain: Spanish Agency of MedicinesTaiwan : Food and Drug AdministrationUnited States: Food and Drug AdministrationVietnam: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Albuminuria
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo

• Linagliptin 5mg

Locations

Country	Name	City	State
Canada	1218.89.11004 Boehringer Ingelheim Investigational Site	Edmonton	Alberta
Canada	1218.89.11002 Boehringer Ingelheim Investigational Site	London	Ontario
Canada	1218.89.11003 Boehringer Ingelheim Investigational Site	Mississauga	Ontario
Canada	1218.89.11006 Boehringer Ingelheim Investigational Site	Mount Pearl	Newfoundland and Labrador
Canada	1218.89.11007 Boehringer Ingelheim Investigational Site	Sarnia	Ontario
Canada	1218.89.11005 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	1218.89.11008 Boehringer Ingelheim Investigational Site	Victoria	British Columbia
Canada	1218.89.11009 Boehringer Ingelheim Investigational Site	Waterloo	Ontario
Denmark	1218.89.45001 Boehringer Ingelheim Investigational Site	Gentofte
Denmark	1218.89.45002 Boehringer Ingelheim Investigational Site	Hillerød
Denmark	1218.89.45003 Boehringer Ingelheim Investigational Site	Silkeborg
Denmark	1218.89.45004 Boehringer Ingelheim Investigational Site	Slagelse
Finland	1218.89.35803 Boehringer Ingelheim Investigational Site	Kerava
Finland	1218.89.35804 Boehringer Ingelheim Investigational Site	Oulu
Finland	1218.89.35801 Boehringer Ingelheim Investigational Site	Tampere
Finland	1218.89.35802 Boehringer Ingelheim Investigational Site	Turku
France	1218.89.33003 Boehringer Ingelheim Investigational Site	Bersée
France	1218.89.33005 Boehringer Ingelheim Investigational Site	Bourg des Comptes
France	1218.89.33007 Boehringer Ingelheim Investigational Site	Grenoble Cedex 09
France	1218.89.33010 Boehringer Ingelheim Investigational Site	Le Creusot
France	1218.89.33001 Boehringer Ingelheim Investigational Site	Marseille cedex
France	1218.89.33008 Boehringer Ingelheim Investigational Site	Saint Mandé cedex
France	1218.89.33011 Boehringer Ingelheim Investigational Site	Vénissieux Cedex
France	1218.89.33004 Boehringer Ingelheim Investigational Site	Vieux Condé
Germany	1218.89.49001 Boehringer Ingelheim Investigational Site	Aschaffenburg
Germany	1218.89.49013 Boehringer Ingelheim Investigational Site	Asslar
Germany	1218.89.49011 Boehringer Ingelheim Investigational Site	Dresden
Germany	1218.89.49002 Boehringer Ingelheim Investigational Site	Düsseldorf
Germany	1218.89.49012 Boehringer Ingelheim Investigational Site	Flörsheim
Germany	1218.89.49003 Boehringer Ingelheim Investigational Site	Pirna
Germany	1218.89.49009 Boehringer Ingelheim Investigational Site	Schweinfurt
Japan	1218.89.81001 Boehringer Ingelheim Investigational Site	Aoba-ku,Sendai,Miyagi
Japan	1218.89.81004 Boehringer Ingelheim Investigational Site	Chiyoda-ku,Tokyo
Japan	1218.89.81002 Boehringer Ingelheim Investigational Site	Cyuo-ku,Tokyo
Japan	1218.89.81008 Boehringer Ingelheim Investigational Site	Kita-ku, Osaka, Osaka
Japan	1218.89.81005 Boehringer Ingelheim Investigational Site	Shimizu-ku,Shizuoka city,Shizuoka
Japan	1218.89.81006 Boehringer Ingelheim Investigational Site	Suita,Osaka
Japan	1218.89.81007 Boehringer Ingelheim Investigational Site	Teine-ku,Sapporo,Hokkaido
Korea, Republic of	1218.89.82001 Boehringer Ingelheim Investigational Site	Goyang
Korea, Republic of	1218.89.82002 Boehringer Ingelheim Investigational Site	Goyang
Korea, Republic of	1218.89.82008 Boehringer Ingelheim Investigational Site	Jinju
Korea, Republic of	1218.89.82006 Boehringer Ingelheim Investigational Site	Seongnam
Korea, Republic of	1218.89.82003 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1218.89.82005 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1218.89.82009 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1218.89.82004 Boehringer Ingelheim Investigational Site	Wonju
Philippines	1218.89.63001 Boehringer Ingelheim Investigational Site	Cebu City, Philippines
Philippines	1218.89.63002 Boehringer Ingelheim Investigational Site	Cebu City, Philippines
Philippines	1218.89.63003 Boehringer Ingelheim Investigational Site	Pasig City, Philippines
Philippines	1218.89.63004 Boehringer Ingelheim Investigational Site	San Juan City, Philippines
Spain	1218.89.34004 Boehringer Ingelheim Investigational Site	L'Hospitalet de Llobregat
Spain	1218.89.34001 Boehringer Ingelheim Investigational Site	Madrid
Spain	1218.89.34007 Boehringer Ingelheim Investigational Site	Madrid
Spain	1218.89.34008 Boehringer Ingelheim Investigational Site	Madrid
Spain	1218.89.34006 Boehringer Ingelheim Investigational Site	Pozuelo de Alarcon
Spain	1218.89.34005 Boehringer Ingelheim Investigational Site	San Sebastian de los Reyes
Spain	1218.89.34002 Boehringer Ingelheim Investigational Site	Valencia
Taiwan	1218.89.88004 Boehringer Ingelheim Investigational Site	Changhua
Taiwan	1218.89.88008 Boehringer Ingelheim Investigational Site	Kaohsiung
Taiwan	1218.89.88002 Boehringer Ingelheim Investigational Site	New Taipei
Taiwan	1218.89.88003 Boehringer Ingelheim Investigational Site	New Taipei
Taiwan	1218.89.88005 Boehringer Ingelheim Investigational Site	Taichung
Taiwan	1218.89.88010 Boehringer Ingelheim Investigational Site	Taichung
Taiwan	1218.89.88006 Boehringer Ingelheim Investigational Site	Tainan
Taiwan	1218.89.88001 Boehringer Ingelheim Investigational Site	Taipei
Taiwan	1218.89.88009 Boehringer Ingelheim Investigational Site	Taipei
United States	1218.89.01004 Boehringer Ingelheim Investigational Site	Asheboro	North Carolina
United States	1218.89.01010 Boehringer Ingelheim Investigational Site	Birmingham	Alabama
United States	1218.89.01017 Boehringer Ingelheim Investigational Site	Charlotte	North Carolina
United States	1218.89.01002 Boehringer Ingelheim Investigational Site	Columbus	Ohio
United States	1218.89.01011 Boehringer Ingelheim Investigational Site	Denver	Colorado
United States	1218.89.01015 Boehringer Ingelheim Investigational Site	Evansville	Indiana
United States	1218.89.01003 Boehringer Ingelheim Investigational Site	Fargo	North Dakota
United States	1218.89.01019 Boehringer Ingelheim Investigational Site	Flint	Michigan
United States	1218.89.01021 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	1218.89.01005 Boehringer Ingelheim Investigational Site	Jackson	Mississippi
United States	1218.89.01016 Boehringer Ingelheim Investigational Site	Knoxville	Tennessee
United States	1218.89.01020 Boehringer Ingelheim Investigational Site	Long Beach	California
United States	1218.89.01018 Boehringer Ingelheim Investigational Site	Miami	Florida
United States	1218.89.01008 Boehringer Ingelheim Investigational Site	North Hollywood	California
United States	1218.89.01013 Boehringer Ingelheim Investigational Site	Oklahoma City	Oklahoma
Vietnam	1218.89.84001 Boehringer Ingelheim Investigational Site	Hanoi, Vietnam
Vietnam	1218.89.84002 Boehringer Ingelheim Investigational Site	Hanoi, Vietnam
Vietnam	1218.89.84006 Boehringer Ingelheim Investigational Site	Hanoi, Vietnam
Vietnam	1218.89.84003 Boehringer Ingelheim Investigational Site	Ho Chi Minh City
Vietnam	1218.89.84004 Boehringer Ingelheim Investigational Site	Ho Chi Minh City
Vietnam	1218.89.84005 Boehringer Ingelheim Investigational Site	Ho Chi Minh City

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Vietnam,  Canada,  Denmark,  Finland,  France,  Germany,  Japan,  Korea, Republic of,  Philippines,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c		24 weeks	No
Secondary	The time weighted average of percentage change from baseline in UACR		24 weeks	No