Linagliptin as Add on to Basal Insulin in the Elderly
- Registration Number
- NCT02240680
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors is also allowed.
In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when added to background basal insulin therapy. The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in glycosylated Haemoglobin, a well-accepted measurement of chronic glycaemic control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 302
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo patient to receive a tablet of placebo matching linagliptin 5 mg linagliptin 5 mg linagliptin patient to receive a tablet of linagliptin 5 mg each day
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment. Baseline and Week 24 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.
- Secondary Outcome Measures
Name Time Method Percentage of Patients Experiencing at Least One Hypoglycaemia Accompanied by a Prespecified Glucose Value. 24 weeks 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.
Percentage of Patients With HbA1c<8.0% 24 weeks 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.
Percentage of Patients With HbA1c on Treatment <7.0% 24 weeks 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.
Percentage of Patients With HbA1c Lowering by at Least 0.5%. 24 weeks 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.
Change From Baseline in Fasting Plasma Glucose (FPG) Baseline and Week 24 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
Trial Locations
- Locations (145)
Jiyugaoka Yamada Clinic
🇯🇵Hokkaido, Obihiro, Japan
Yoshida Memorial Hospital
🇯🇵Hokkaido, Sapporo, Japan
East Coast Institute for Research LLC at NE FL Endo & Diabetes
🇺🇸Jacksonville, Florida, United States
Solutions Through Advanced Research, Inc.
🇺🇸Jacksonville, Florida, United States
Office of Dr. Val R. Hansen
🇺🇸Bountiful, Utah, United States
ECRU Maroondah
🇦🇺East Ringwood, Victoria, Australia
Keravan terveyskeskus
🇫🇮Kerava, Finland
Terveystalo Oulu, Diapolis
🇫🇮Oulu, Finland
Praxis Dr. Naudts, Rodgau
🇩🇪Rodgau, Germany
Praxis Dr. Braun, Unterschneidheim
🇩🇪Unterschneidheim, Germany
General Hospital of Athens "G. Gennimatas"
🇬🇷Athens, Greece
CEQUIN
🇨🇴Armenia, Colombia
Dexa Diabetes Servicios Médicos Ltda
🇨🇴Bogotá, Colombia
CAFAM Caja de Compensación Familiar
🇨🇴Bogotá, Colombia
Asociacion IPS Medicos Internistas de Caldas
🇨🇴Manizales, Colombia
Hospital Pablo Tobón Uribe
🇨🇴Medellín, Colombia
TYKS
🇫🇮Turku, Finland
ikfe - Institut für klinische Forschung und Entwicklung Berlin GmbH
🇩🇪Berlin, Germany
Dünnwaldpraxis, Köln
🇩🇪Koeln, Germany
Univ. Gen. Hosp. of Ioannina
🇬🇷Ioannina, Greece
General Hospital of Attiki "KAT-EKA"
🇬🇷Kifisia, Greece
Connolly Hospital Blanchardstown
🇮🇪Dublin, Ireland
Matsuyama Shimin Hospital
🇯🇵Ehime, Matsuyama, Japan
Iryohojin Kikuchi Naika Clinic
🇯🇵Gunma, Maebashi, Japan
General Hospital of Nikaia
🇬🇷Nikaia, Greece
Tokyo-Eki Center-building Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Investigación en Salud y Metabolismo S.C.
🇲🇽Chihuahua, Mexico
Daishinkai Medical Corporation Ookuma Hospital
🇯🇵Aichi, Nagoya, Japan
Iida Medical Clinic
🇯🇵Hokkaido, Hakodate, Japan
Kaneshiro DIAB Clinic, Kanagawa, I.M.
🇯🇵Kanagawa, Sagamihara, Japan
Asano Clinic
🇯🇵Saitama, Kawagoe, Japan
AGE Makita Medical Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Teine Keijinkai Clinic
🇯🇵Hokkaido, Sapporo, Japan
Japan Community Health Care Organization Hokkaido Hospital
🇯🇵Hokkaido, Sapporo, Japan
Asahi Med. clinic, Kanagawa, I.M.
🇯🇵Kanagawa, Yokohama, Japan
Takai Naika Clinic
🇯🇵Kanagawa, Kamakura, Japan
Okayama Saiseikai General Hospital Outpatient Center
🇯🇵Okayama, Okayama, Japan
AMC Nishi-umeda Clinic
🇯🇵Osaka, Osaka, Japan
Hamamatsu Rosai Hospital
🇯🇵Shizuoka, Hamamatsu, Japan
Kunitachi Naika Clinic
🇯🇵Tokyo, Kunitachi, Japan
Omedica Centrum Medyczne
🇵🇱Poznan, Poland
NBR Polska
🇵🇱Warszawa, Poland
Nissay Hospital Nippon Life Saiseikai Public Interest Incorporated Foundation
🇯🇵Osaka, Osaka, Japan
Kobayashi Internal Medicine Clinic
🇯🇵Tokyo, Koto-ku, Japan
CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc
🇲🇽México, Mexico
Tokyo Center Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Japanese Red Cross Medical Center
🇯🇵Tokyo, Shibuya-ku, Japan
Clinstile S.A. de C.V.
🇲🇽México, Mexico
Centro de At. e Inv.en Fact.de riesgo cardiovasc.Omega, S.C.
🇲🇽Mexico, Mexico
Asociación Mexicana para la Investigacion Clínica, A.C(AMIC)
🇲🇽Pachuca, Mexico
Pelican Impex SRL, Cabinet Nr. 15
🇷🇴Oradea, Romania
South Pacific Clinical Trials
🇳🇿Auckland, New Zealand, New Zealand
Middlemore Clinical Trials
🇳🇿Auckland, New Zealand
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Precision Research Institute, LLC
🇺🇸Chula Vista, California, United States
Riverside Clinical Research
🇺🇸Edgewater, Florida, United States
Family Practice Center of Wadsworth, Inc.
🇺🇸Wadsworth, Ohio, United States
Advanced Research Associates
🇺🇸Hodges, South Carolina, United States
General Hospital of Thessaloniki "G. Papanikolaou"
🇬🇷Thessaloniki, Greece
National Hospital Organization Yokohama Medical Center
🇯🇵Kanagawa, Yokohama, Japan
CAIMED
🇲🇽Mexico, Mexico
Nicodiab SRL, Bucharest
🇷🇴Bucharest, Romania
Medicome Sp. z o.o.
🇵🇱Oswiecim, Poland
Resego Health Services
🇿🇦Johannesburg, South Africa
TREAD Research
🇿🇦Cape Town, South Africa
Soweto Clinical Trials Centre
🇿🇦Johannesburg, South Africa
Paarl Research Centre
🇿🇦Cape Town, South Africa
LCS Clinical Research Unit
🇿🇦Johannesburg, South Africa
Zinakekele Medical Centre
🇿🇦KwaMhlanga, South Africa
VX Pharma (Pty) Ltd Pretoria
🇿🇦Pretoria, South Africa
Hospital A Coruña
🇪🇸A Coruña, Spain
Hospital Quiron. I.C.U.
🇪🇸Barcelona, Spain
Oak Tree Surgery
🇬🇧Liskeard, United Kingdom
Gentofte University Hospital
🇩🇰Hellerup, Denmark
TLM Medical Services, LLC
🇺🇸Columbia, South Carolina, United States
Aurora Care Clinic, LLC
🇺🇸Costa Mesa, California, United States
Prime Care Clinical Research
🇺🇸Laguna Hills, California, United States
Panax Clinical Research
🇺🇸Miami Lakes, Florida, United States
International Research Associates
🇺🇸Miami, Florida, United States
South Florida Research Solutions, LLC
🇺🇸Pembroke Pines, Florida, United States
Renaissance Clinical Research and Hypertension of Texas
🇺🇸Dallas, Texas, United States
Family Medical Clinic
🇺🇸Milwaukee, Wisconsin, United States
Cohen Medical Research Associates, LLC
🇺🇸Delray Beach, Florida, United States
Accent Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Clinical Research of South Nevada
🇺🇸Las Vegas, Nevada, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Houston Clinical Research Associates
🇺🇸Houston, Texas, United States
CAP El Remei
🇪🇸Vic, Spain
Midwest Endocrinology
🇺🇸Crystal Lake, Illinois, United States
Preferred Primary Care Phys
🇺🇸Uniontown, Pennsylvania, United States
Internal Medicine of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Syed Research Consultants, LLC
🇺🇸Sheffield, Alabama, United States
Torrance Clinical Research Institute Inc.
🇺🇸Lomita, California, United States
Clinical Research of Hollywood
🇺🇸Hollywood, Florida, United States
Baptist Diabetes Associates, PA
🇺🇸Miami, Florida, United States
Arlington Family Research Center, Inc.
🇺🇸Arlington, Texas, United States
Manhattan Medical Research Practice PLLC
🇺🇸New York, New York, United States
Georgia Clinical Research, LLC
🇺🇸Snellville, Georgia, United States
American Health Network
🇺🇸Avon, Indiana, United States
Clinical Research Associates of Central Pennsylvania
🇺🇸Altoona, Pennsylvania, United States
Science Advancing Medicine Clinical Research Center
🇺🇸San Antonio, Texas, United States
York Clinical Research, LLC
🇺🇸Norfolk, Virginia, United States
Bispebjerg Hospital
🇩🇰København NV, Denmark
Royal Brisbane & Women's Hospital-Endocrinology
🇦🇺Herston, Queensland, Australia
Millennium Clinical Trials LLC
🇺🇸Arlington, Virginia, United States
Køge Sygehus
🇩🇰Køge, Denmark
Mzansi Ethical Research Centre
🇿🇦Middleburg, South Africa
Fowey Clinical Research Company Ltd
🇬🇧Fowey, United Kingdom
Rame Medical, Penntorr Health
🇬🇧Torpoint, United Kingdom
Hospital Nuestra Señora de Valme
🇪🇸Sevilla, Spain
Instituto de Ciencias Médicas
🇪🇸Alicante, Spain
Hospital Virgen de la Victoria
🇪🇸Malaga, Spain
Rowan Research, Inc.
🇺🇸Spokane, Washington, United States
AIM Centre
🇦🇺Merewether, New South Wales, Australia
Ishikawa Med. Clinic, Kanagawa, I.M.
🇯🇵Kanagawa, Yokohama, Japan
Ham - PRAC Mortelmans
🇧🇪Oostham, Belgium
Sydvestjyst Sygehus Esbjerg, Endokrinologisk afdeling
🇩🇰Esbjerg, Denmark
Frederiksberg Hospital, Endokrinologisk afd.
🇩🇰Frederiksberg, Denmark
Kolding Sygehus
🇩🇰Kolding, Denmark
Roskilde Sygehus
🇩🇰Roskilde, Denmark
OCROM Clinic
🇯🇵Osaka, Suita, Japan
Kuriyama Clinic
🇯🇵Tokyo, Adachi-ku, Japan
The Institute for Adult Deseases, Asahi Life Foundation
🇯🇵Tokyo, Chuo-ku, Japan
The Haven Surgery
🇬🇧Burnhope, United Kingdom
Mounts Bay Medical Ltd
🇬🇧Penzance, United Kingdom
C.A.P. Sardenya
🇪🇸Barcelona, Spain
Gemeinschaftspraxis, Asslar
🇩🇪Asslar, Germany
Diabetologische Schwerpunktpraxis, Bosenheim
🇩🇪Bosenheim, Germany
CAP Les Corts
🇪🇸Barcelona, Spain
CAP Canet de Mar
🇪🇸Canet de Mar, Spain
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
"Korgialeneio-Benakeio" Hellenic Red Cross Hospital
🇬🇷Athens, Greece
Nakamura Digestive Organ Internal Medicine Clinic
🇯🇵Hokkaido, Bibai, Japan
Shinkotoni family Clinic
🇯🇵Hokkaido, Sapporo, Japan
Itabashi Diabetic medicine and Dermatology Clinic
🇯🇵Ibaraki, Koga, Japan
Nakakinen Clinic
🇯🇵Ibaraki, Naka, Japan
Mediab SRL
🇷🇴Tirgu Mures, Romania
South Axholme Practice
🇬🇧Doncaster, United Kingdom
St. Mary's Hospital, Vectasearch Clinic, Newport
🇬🇧Newport, United Kingdom
Tiervlei Trial Centre
🇿🇦Cape Town, South Africa
Lääkärikeskus Aava, Turku
🇫🇮Turku, Finland
Aalborg Sygehus Syd
🇩🇰Aalborg, Denmark
Diabetes and Thyroid Center of Fort Worth
🇺🇸Fort Worth, Texas, United States
Saga Memorial Hospital
🇯🇵Saga, Saga, Japan
Fleetwood Clinical Research
🇺🇸Fleetwood, Pennsylvania, United States