Linagliptin as Add on to Basal Insulin in the Elderly
A 24 Week Randomized, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Trial of Once Daily Linagliptin, 5 Milligrams Orally, as Add on to Basal Insulin in Elderly Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control
2 other identifiers
interventional
302
17 countries
145
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus-type-2
Started Sep 2014
Typical duration for phase_4 diabetes-mellitus-type-2
145 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2014
CompletedFirst Posted
Study publicly available on registry
September 16, 2014
CompletedStudy Start
First participant enrolled
September 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2017
CompletedResults Posted
Study results publicly available
July 3, 2018
CompletedJuly 3, 2018
May 1, 2018
2.6 years
September 15, 2014
April 17, 2018
June 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Percentage of Patients Experiencing at Least One Hypoglycaemia Accompanied by a Prespecified Glucose Value.
24 weeks
Percentage of Patients With HbA1c<8.0%
24 weeks
Percentage of Patients With HbA1c on Treatment <7.0%
24 weeks
Percentage of Patients With HbA1c Lowering by at Least 0.5%.
24 weeks
Change From Baseline in Fasting Plasma Glucose (FPG)
Baseline and Week 24
Study Arms (2)
linagliptin 5 mg
EXPERIMENTALpatient to receive a tablet of linagliptin 5 mg each day
placebo
PLACEBO COMPARATORpatient to receive a tablet of placebo matching linagliptin 5 mg
Interventions
Eligibility Criteria
You may qualify if:
- Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation and Good Clinical Practice guidelines and local regulations prior to any evaluation and participation in the trial.
- Male and female patients with a clinical diagnosis of Type 2 Diabetes Mellitus, at the time of Informed Consent, who are:
- years of age or older at informed consent or Screen Visit,
- taking stable doses of basal or biosimilar basal insulin \[strictly inclusive of: insulin neutral protamine Hagedorn and isophane insulin; Humalog Basal (a suspension of insulin lispro protamine); insulin degludec; insulin detemir; and insulin glargine\] for at least 4 weeks prior to randomisation (Visit 3) with dose adjustments up to a maximum of plus or minus 20% of baseline being allowed,
- may or may not be taking metformin immediate release or extended release \[if the patient is taking metformin, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (Visit 3)\], and
- may or may not be taking alpha-glucosidase inhibitors \[acarbose, miglitol, and voglibose; if the patient is taking alpha-glucosidase inhibitors, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (Visit 3)\].
- Patients must have an glycosylated Haemoglobin of 7.0% (53 millimoles per mole) to 10.0% (86 millimoles per mole) at the first visit (Screen).
- Patients must have a Body Mass Index of 45 kilogram/meter squared or less at the Screen Visit.
- In the investigator's opinion, patients must be reliable, compliant, and agree to cooperate with all planned future trial evaluations as explained in detail during the informed consent process and to be able to perform them.
You may not qualify if:
- Impaired cognitive ability as supported by the Saint Louis University Mental Status Examination, additional assessment if necessary, and verified by the investigator at the Screen Visit.
- Depressed mood as supported by a score of 10 or more on the Patient Health Questionnaire at the Screen Visit.
- Type 1 Diabetes Mellitus as determined by past medical records and history.
- Acute coronary syndrome (non-ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction, and/or unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to Screen Visit.
- Indication of liver disease determined during Screen and/or Run-In Period, defined by a serum level above 3 times the upper limit of normal in any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase.
- Bariatric, gastric bypass, and other gastrointestinal procedures or surgeries (including all types of gastric banding, restriction, and/or LapBand) with the objective of promoting weight loss within the past two years at Screen Visit.
- Medical history of cancer (except for resected non-invasive basal or squamous cell carcinoma) and/or treatment for cancer within the last 5 years.
- Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (malaria, babesiosis, haemolytic anaemia).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boehringer Ingelheimlead
- Eli Lilly and Companycollaborator
Study Sites (145)
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
Baptist Diabetes Associates, PA
Miami, Florida, 33156, United States
International Research Associates
Miami, Florida, 33183, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, 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
Cologne, 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"
Kifissia, 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 City, 31217, Mexico
Centro de At. e Inv.en Fact.de riesgo cardiovasc.Omega, S.C.
México, 06400, Mexico
Clinstile S.A. de C.V.
México, 06700, Mexico
CAIMED
México, 06760, 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
Middlemore Clinical Trials
Auckland, 2025, New Zealand
South Pacific Clinical Trials
Auckland, New Zealand, 0610, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
Medicome Sp. z o.o.
Oświęcim, 32-600, Poland
Omedica Centrum Medyczne
Poznan, 60-111, Poland
NBR Polska
Warsaw, 00-465, Poland
Nicodiab SRL, Bucharest
Bucharest, 010507, Romania
Pelican Impex SRL, Cabinet Nr. 15
Oradea, 410469, Romania
Mediab SRL
Târgu Mureş, 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
Málaga, 29010, Spain
Hospital Nuestra Señora de Valme
Seville, 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
Related Publications (1)
Araki E, Unno Y, Tanaka Y, Sakamoto W, Miyamoto Y. Long-Term Efficacy and Safety of Linagliptin in a Japanese Population with Type 2 Diabetes Aged >/= 60 Years Treated with Basal Insulin: A Randomised Trial. Adv Ther. 2019 Oct;36(10):2697-2711. doi: 10.1007/s12325-019-01065-7. Epub 2019 Sep 3.
PMID: 31482511DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
For patients in Japan, a local protocol amendment was introduced, and according to it the study was extended to 52 weeks for Japanese population only.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2014
First Posted
September 16, 2014
Study Start
September 23, 2014
Primary Completion
April 18, 2017
Study Completion
April 25, 2017
Last Updated
July 3, 2018
Results First Posted
July 3, 2018
Record last verified: 2018-05