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Clinical Trial Details

Trial ID: L2725
Source ID: NCT02240680
Associated Drug: Placebo
Title: Linagliptin as Add on to Basal Insulin in the Elderly
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02240680/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: placebo|DRUG: linagliptin
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment., This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range., Baseline and Week 24 | Secondary: Percentage of Patients Experiencing at Least One Hypoglycaemia Accompanied by a Prespecified Glucose Value., Hypoglycaemia accompanied by a prespecified glucose value is defined as any investigator reported hypoglycaemia (event or AE) with a reported blood glucose level of less than 54 milligram/deciLitre (3.0 millimole/Litre) or any investigator reported symptomatic hypoglycaemic AE with a reported blood glucose level of less or equal 70 milligram/deciLitre (3.9millimole/Litre) or any severe hypoglycaemic AE. Severe hypoglycaemia is an event that requires the assistance of another person to actively administer carbohydrates or glucagon because the patient is unable to take the substance on his or her own. The confidence intervals mentioned in measure of dispersion are exact 95% confidence interval by Clopper and Pearson. The percentage of patients with at least one hypoglycaemia accompanied by a glucose value less than 54mg/dL alone has also represented separately according American Diabetes Association definition of clinically significant hypoglycaemia., 24 weeks|Percentage of Patients With HbA1c<8.0%, This is the percentage of patients with HbA1c on treatment \<8.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson., 24 weeks|Percentage of Patients With HbA1c on Treatment <7.0%, This is the percentage of patients with HbA1c on treatment \<7.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson., 24 weeks|Percentage of Patients With HbA1c Lowering by at Least 0.5%., The percentage of patients who attained lowering of HbA1c by ≥0.5% from baseline after 24 weeks of treatment were analysed. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson., 24 weeks|Change From Baseline in Fasting Plasma Glucose (FPG), This outcome has measured difference between FPG values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication, Baseline and Week 24
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 302
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-09-23
Completion Date: 2017-04-25
Results First Posted: 2018-07-03
Last Update Posted: 2018-07-03
Locations: Syed Research Consultants, LLC, Sheffield, Alabama, 35660, United States|Precision Research Institute, LLC, Chula Vista, California, 91910, United States|Aurora Care Clinic, LLC, Costa Mesa, California, 92627, United States|Prime Care Clinical Research, Laguna Hills, California, 92653, United States|Torrance Clinical Research Institute Inc., Lomita, California, 90717, United States|Internal Medicine of the Rockies, Colorado Springs, Colorado, 80910, United States|Cohen Medical Research Associates, LLC, Delray Beach, Florida, 33446, United States|Riverside Clinical Research, Edgewater, Florida, 32132, United States|Clinical Research of Hollywood, Hollywood, Florida, 33024, United States|East Coast Institute for Research LLC at NE FL Endo & Diabetes, Jacksonville, Florida, 32204, United States|Solutions Through Advanced Research, Inc., Jacksonville, Florida, 32258, United States|Panax Clinical Research, Miami Lakes, Florida, 33014, United States|Baptist Diabetes Associates, PA, Miami, Florida, 33156, United States|International Research Associates, Miami, Florida, 33183, United States|South Florida Research Solutions, LLC, Pembroke Pines, Florida, 33026, United States|Georgia Clinical Research, LLC, Snellville, Georgia, 30078, United States|Midwest Endocrinology, Crystal Lake, Illinois, 60012, United States|American Health Network, Avon, Indiana, 46123, United States|Accent Clinical Trials, Las Vegas, Nevada, 89052, United States|Clinical Research of South Nevada, Las Vegas, Nevada, 89121, United States|Manhattan Medical Research Practice PLLC, New York, New York, 10016, United States|Family Practice Center of Wadsworth, Inc., Wadsworth, Ohio, 44281, United States|Clinical Research Associates of Central Pennsylvania, Altoona, Pennsylvania, 16602, United States|Fleetwood Clinical Research, Fleetwood, Pennsylvania, 19522, United States|Preferred Primary Care Phys, Uniontown, Pennsylvania, 15401, United States|TLM Medical Services, LLC, Columbia, South Carolina, 29204, United States|Advanced Research Associates, Hodges, South Carolina, 29653, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Arlington Family Research Center, Inc., Arlington, Texas, 76012, United States|Renaissance Clinical Research and Hypertension of Texas, Dallas, Texas, 75234, United States|Diabetes and Thyroid Center of Fort Worth, Fort Worth, Texas, 76132, United States|Houston Clinical Research Associates, Houston, Texas, 77090, United States|Science Advancing Medicine Clinical Research Center, San Antonio, Texas, 78229, United States|Office of Dr. Val R. Hansen, Bountiful, Utah, 84010, United States|Millennium Clinical Trials LLC, Arlington, Virginia, 22203, United States|York Clinical Research, LLC, Norfolk, Virginia, 23510, United States|Rowan Research, Inc., Spokane, Washington, 99218, United States|Family Medical Clinic, Milwaukee, Wisconsin, 53216, United States|AIM Centre, Merewether, New South Wales, 2291, Australia|Royal Brisbane & Women's Hospital-Endocrinology, Herston, Queensland, 4029, Australia|ECRU Maroondah, East Ringwood, Victoria, 3135, Australia|Ham - PRAC Mortelmans, Oostham, 3945, Belgium|CEQUIN, Armenia, 630004, Colombia|Dexa Diabetes Servicios Médicos Ltda, Bogotá, 110221, Colombia|CAFAM Caja de Compensación Familiar, Bogotá, 111211, Colombia|Asociacion IPS Medicos Internistas de Caldas, Manizales, 170004, Colombia|Hospital Pablo Tobón Uribe, Medellín, 050034, Colombia|Aalborg Sygehus Syd, Aalborg, 9100, Denmark|Sydvestjyst Sygehus Esbjerg, Endokrinologisk afdeling, Esbjerg, 6700, Denmark|Frederiksberg Hospital, Endokrinologisk afd., Frederiksberg, 2000, Denmark|Gentofte University Hospital, Hellerup, 2900, Denmark|Kolding Sygehus, Kolding, 6000, Denmark|Bispebjerg Hospital, København NV, 2400, Denmark|Køge Sygehus, Køge, 4600, Denmark|Roskilde Sygehus, Roskilde, 4000, Denmark|Keravan terveyskeskus, Kerava, 04200, Finland|Terveystalo Oulu, Diapolis, Oulu, FI-90100, Finland|Lääkärikeskus Aava, Turku, Turku, 20520, Finland|TYKS, Turku, FI-20520, Finland|Gemeinschaftspraxis, Asslar, Asslar, 35614, Germany|ikfe - Institut für klinische Forschung und Entwicklung Berlin GmbH, Berlin, 10115, Germany|Diabetologische Schwerpunktpraxis, Bosenheim, Bosenheim, 55545, Germany|Dünnwaldpraxis, Köln, Koeln, 51069, Germany|Praxis Dr. Naudts, Rodgau, Rodgau, 63110, Germany|Praxis Dr. Braun, Unterschneidheim, Unterschneidheim, 73485, Germany|"Korgialeneio-Benakeio" Hellenic Red Cross Hospital, Athens, 115 26, Greece|General Hospital of Athens "G. Gennimatas", Athens, 11527, Greece|Univ. Gen. Hosp. of Ioannina, Ioannina, 45500, Greece|General Hospital of Attiki "KAT-EKA", Kifisia, 14561, Greece|General Hospital of Nikaia, Nikaia, 18454, Greece|General Hospital of Thessaloniki "G. Papanikolaou", Thessaloniki, 57010, Greece|Connolly Hospital Blanchardstown, Dublin, Dublin 15, Ireland|Daishinkai Medical Corporation Ookuma Hospital, Aichi, Nagoya, 462-0825, Japan|Matsuyama Shimin Hospital, Ehime, Matsuyama, 790-0067, Japan|Iryohojin Kikuchi Naika Clinic, Gunma, Maebashi, 370-3573, Japan|Nakamura Digestive Organ Internal Medicine Clinic, Hokkaido, Bibai, 072-0012, Japan|Iida Medical Clinic, Hokkaido, Hakodate, 042-0942, Japan|Jiyugaoka Yamada Clinic, Hokkaido, Obihiro, 080-0848, Japan|Shinkotoni family Clinic, Hokkaido, Sapporo, 001-0912, Japan|Yoshida Memorial Hospital, Hokkaido, Sapporo, 003-0026, Japan|Teine Keijinkai Clinic, Hokkaido, Sapporo, 006-0811, Japan|Japan Community Health Care Organization Hokkaido Hospital, Hokkaido, Sapporo, 062-8618, Japan|Itabashi Diabetic medicine and Dermatology Clinic, Ibaraki, Koga, 306-0232, Japan|Nakakinen Clinic, Ibaraki, Naka, 311-0113, Japan|Takai Naika Clinic, Kanagawa, Kamakura, 247-0056, Japan|Kaneshiro DIAB Clinic, Kanagawa, I.M., Kanagawa, Sagamihara, 252-0302, Japan|Asahi Med. clinic, Kanagawa, I.M., Kanagawa, Yokohama, 221-0802, Japan|Ishikawa Med. Clinic, Kanagawa, I.M., Kanagawa, Yokohama, 241-0821, Japan|National Hospital Organization Yokohama Medical Center, Kanagawa, Yokohama, 245-8575, Japan|Okayama Saiseikai General Hospital Outpatient Center, Okayama, Okayama, 700-8511, Japan|AMC Nishi-umeda Clinic, Osaka, Osaka, 530-0001, Japan|Nissay Hospital Nippon Life Saiseikai Public Interest Incorporated Foundation, Osaka, Osaka, 550-0012, Japan|OCROM Clinic, Osaka, Suita, 565-0853, Japan|Saga Memorial Hospital, Saga, Saga, 849-0917, Japan|Asano Clinic, Saitama, Kawagoe, 350-0851, Japan|Hamamatsu Rosai Hospital, Shizuoka, Hamamatsu, 430-8525, Japan|Kuriyama Clinic, Tokyo, Adachi-ku, 121-0064, Japan|The Institute for Adult Deseases, Asahi Life Foundation, Tokyo, Chuo-ku, 103-0002, Japan|Tokyo-Eki Center-building Clinic, Tokyo, Chuo-ku, 103-0027, Japan|Tokyo Center Clinic, Tokyo, Chuo-ku, 103-0028, Japan|AGE Makita Medical Clinic, Tokyo, Chuo-ku, 104-0061, Japan|Kobayashi Internal Medicine Clinic, Tokyo, Koto-ku, 135-0011, Japan|Kunitachi Naika Clinic, Tokyo, Kunitachi, 186-0002, Japan|Japanese Red Cross Medical Center, Tokyo, Shibuya-ku, 150-8935, Japan|Investigación en Salud y Metabolismo S.C., Chihuahua, 31217, Mexico|Centro de At. e Inv.en Fact.de riesgo cardiovasc.Omega, S.C., Mexico, 06400, Mexico|CAIMED, Mexico, 06760, Mexico|Clinstile S.A. de C.V., México, 06700, Mexico|CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc, México, C.P. 11650, Mexico|Asociación Mexicana para la Investigacion Clínica, A.C(AMIC), Pachuca, 42070, Mexico|South Pacific Clinical Trials, Auckland, New Zealand, 0610, New Zealand|Middlemore Clinical Trials, Auckland, 2025, New Zealand|Christchurch Hospital, Christchurch, 8011, New Zealand|Medicome Sp. z o.o., Oswiecim, 32-600, Poland|Omedica Centrum Medyczne, Poznan, 60-111, Poland|NBR Polska, Warszawa, 00-465, Poland|Nicodiab SRL, Bucharest, Bucharest, 010507, Romania|Pelican Impex SRL, Cabinet Nr. 15, Oradea, 410469, Romania|Mediab SRL, Tirgu Mures, 540142, Romania|TREAD Research, Cape Town, 7500, South Africa|Tiervlei Trial Centre, Cape Town, 7530, South Africa|Paarl Research Centre, Cape Town, 7646, South Africa|Soweto Clinical Trials Centre, Johannesburg, 1818, South Africa|LCS Clinical Research Unit, Johannesburg, 2021, South Africa|Resego Health Services, Johannesburg, 2189, South Africa|Zinakekele Medical Centre, KwaMhlanga, 1022, South Africa|Mzansi Ethical Research Centre, Middleburg, 1055, South Africa|VX Pharma (Pty) Ltd Pretoria, Pretoria, 0087, South Africa|Hospital A Coruña, A Coruña, 15003, Spain|Instituto de Ciencias Médicas, Alicante, 03004, Spain|Hospital Quiron. I.C.U., Barcelona, 08023, Spain|C.A.P. Sardenya, Barcelona, 08025, Spain|CAP Les Corts, Barcelona, 08028, Spain|CAP Canet de Mar, Canet de Mar, 08360, Spain|Hospital Virgen de la Victoria, Malaga, 29010, Spain|Hospital Nuestra Señora de Valme, Sevilla, 41014, Spain|Hospital Clínico de Valencia, Valencia, 46010, Spain|CAP El Remei, Vic, 08500, Spain|The Haven Surgery, Burnhope, DH7 0BD, United Kingdom|South Axholme Practice, Doncaster, DN9 2HY, United Kingdom|Fowey Clinical Research Company Ltd, Fowey, PL23 1DT, United Kingdom|Oak Tree Surgery, Liskeard, PL14 3XA, United Kingdom|St. Mary's Hospital, Vectasearch Clinic, Newport, Newport, PO309 5TG, United Kingdom|Mounts Bay Medical Ltd, Penzance, TR19 7HX, United Kingdom|Rame Medical, Penntorr Health, Torpoint, PL11 2TB, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02240680

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress