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Clinical Trial Details

Trial ID: L4553
Source ID: NCT01792518
Associated Drug: Placebo
Title: MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01792518/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo|DRUG: Linagliptin 5mg
Outcome Measures: Primary: HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment, 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: The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment, 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, 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
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 360
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2013-02
Completion Date: 2015-12
Results First Posted: 2017-03-06
Last Update Posted: 2017-03-06
Locations: Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States|Boehringer Ingelheim Investigational Site, Long Beach, California, United States|Boehringer Ingelheim Investigational Site, North Hollywood, California, United States|Boehringer Ingelheim Investigational Site, Denver, Colorado, United States|Boehringer Ingelheim Investigational Site, Miami, Florida, United States|Boehringer Ingelheim Investigational Site, Evansville, Indiana, United States|Boehringer Ingelheim Investigational Site, Flint, Michigan, United States|Boehringer Ingelheim Investigational Site, Jackson, Mississippi, United States|Boehringer Ingelheim Investigational Site, Asheboro, North Carolina, United States|Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States|Boehringer Ingelheim Investigational Site, Fargo, North Dakota, United States|Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States|Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States|Boehringer Ingelheim Investigational Site, Knoxville, Tennessee, United States|Boehringer Ingelheim Investigational Site, Houston, Texas, United States|Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada|Boehringer Ingelheim Investigational Site, Victoria, British Columbia, Canada|Boehringer Ingelheim Investigational Site, Mount Pearl, Newfoundland and Labrador, Canada|Boehringer Ingelheim Investigational Site, 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, Gentofte, Denmark|Boehringer Ingelheim Investigational Site, Hillerød, Denmark|Boehringer Ingelheim Investigational Site, Silkeborg, Denmark|Boehringer Ingelheim Investigational Site, Slagelse, Denmark|Boehringer Ingelheim Investigational Site, Kerava, Finland|Boehringer Ingelheim Investigational Site, Oulu, Finland|Boehringer Ingelheim Investigational Site, Tampere, Finland|Boehringer Ingelheim Investigational Site, Turku, Finland|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|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|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|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|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|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|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|Boehringer Ingelheim Investigational Site, Hanoi, Vietnam, Vietnam|Boehringer Ingelheim Investigational Site, Ho Chi Minh City, Vietnam
URL: https://clinicaltrials.gov/show/NCT01792518

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress