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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002603-17 | EudraCT Number | EudraCT |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linagliptin 5mg | Experimental | linagliptin 5 mg once daily |
|
| placebo | Placebo Comparator | matching placebo for linagliptin dose once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| Linagliptin 5mg |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |||
| Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30632692 | Derived | 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. | |
| 28636754 | Derived |
Not provided
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Randomized, double-blind, placebo controlled, parallel group study to evaluate glycemic and renal efficacy of once daily administration of Linagliptin 5 milligram (mg) for 24 weeks in type 2 diabetes patients, with micro- or macroalbuminuria on top of current treatment with Angiotensin Converting Enzyme inhibitor or Angiotensin Receptor Blocker
360 patients were randomised and treated (Placebo: 178 patients, Linagliptin: 182 patients.)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period. |
| FG001 | Linagliptin 5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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|
| 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 |
| 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 Municipality | 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 | France |
| Boehringer Ingelheim Investigational Site | Le Creusot | France |
| Boehringer Ingelheim Investigational Site | Marseille | France |
| Boehringer Ingelheim Investigational Site | Saint-Mandé | France |
| Boehringer Ingelheim Investigational Site | Vénissieux | France |
| Boehringer Ingelheim Investigational Site | Vieux-Condé | 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 | 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 | Goyang | South Korea |
| Boehringer Ingelheim Investigational Site | Jinju | South Korea |
| Boehringer Ingelheim Investigational Site | Seongnam | South Korea |
| Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site | Wŏnju | South Korea |
| Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat | Spain |
| Boehringer Ingelheim Investigational Site | Madrid | Spain |
| Boehringer Ingelheim Investigational Site | Pozuelo de Alarcón | Spain |
| Boehringer Ingelheim Investigational Site | San Sebastián de los Reyes | Spain |
| Boehringer Ingelheim Investigational Site | Valencia | Spain |
| Boehringer Ingelheim Investigational Site | Changhua | Taiwan |
| Boehringer Ingelheim Investigational Site | Kaohsiung City | Taiwan |
| Boehringer Ingelheim Investigational Site | New Taipei City | 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 |
| 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. |
| 26224765 | Derived | 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. |
Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated Set (TS) - including all patients treated with at least one dose of randomised trial medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period. |
| BG001 | Linagliptin 5 mg | Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full Analysis Set (FAS) - including all randomised patients who were treated with at least one dose of study drug, had a baseline HbA1c and a baseline Urinary albumin creatinine ratio (UACR), and at least one on treatment HbA1c or UACR assessment. Observed Case (OC): Values after the use of rescue medication were set to missing. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | 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. | Full Analysis Set (FAS) - including all randomised patients who were treated with at least one dose of study drug, had a baseline HbA1c and a baseline Urinary albumin creatinine ratio (UACR), and at least one on treatment HbA1c or UACR assessment. Last Observation Carried Forward (LOCF). | Posted | Least Squares Mean | 95% Confidence Interval | mg/g creatinine | Baseline and 24 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Treated Set | Posted | Least Squares Mean | Standard Error | milliliter/minute/1.73 square metre | Baseline and 24 weeks |
|
|
From first drug administration until 28 days after the last drug administration, up to 240 days
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period. | 8 | 178 | 27 | 178 | ||
| EG001 | Linagliptin 5 mg | Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period. | 17 | 182 | 39 | 182 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrointestinal fistula | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Arteriovenous graft site infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Peripheral nerve injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Postpericardiotomy syndrome | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Aortic occlusion | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Necrosis ischaemic | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
Not provided
Not provided
| Male |
|
| No |
| Superiority or Other |
| Units | Counts |
|---|
| Participants |
|
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