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Diabetes Mellitus, Type 2Phase 4NCT02240680

Linagliptin as Add on to Basal Insulin in the Elderly

A Phase 4 study testing linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 145 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
linagliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
302 participants
Where
145 sitesin 17 countries
Study dates
23 Sep 2014to 25 Apr 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 60 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)].
Show all 9Show fewer
  • 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.

Who cannot join

  • 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).

Trial locations and contacts

145 sites in 17 countries.

145 sites in 17 countries

United States38 sites

  • Clinical Research Associates of Central Pennsylvania

    Altoona, Pennsylvania, 16602

  • Arlington Family Research Center, Inc.

    Arlington, Texas, 76012

  • Millennium Clinical Trials LLC

    Arlington, Virginia, 22203

  • American Health Network

    Avon, Indiana, 46123

  • Office of Dr. Val R. Hansen

    Bountiful, Utah, 84010

  • Precision Research Institute, LLC

    Chula Vista, California, 91910

  • Internal Medicine of the Rockies

    Colorado Springs, Colorado, 80910

  • TLM Medical Services, LLC

    Columbia, South Carolina, 29204

  • Aurora Care Clinic, LLC

    Costa Mesa, California, 92627

  • Midwest Endocrinology

    Crystal Lake, Illinois, 60012

  • Renaissance Clinical Research and Hypertension of Texas

    Dallas, Texas, 75234

  • Cohen Medical Research Associates, LLC

    Delray Beach, Florida, 33446

  • Riverside Clinical Research

    Edgewater, Florida, 32132

  • Fleetwood Clinical Research

    Fleetwood, Pennsylvania, 19522

  • Diabetes and Thyroid Center of Fort Worth

    Fort Worth, Texas, 76132

  • Advanced Research Associates

    Hodges, South Carolina, 29653

  • Clinical Research of Hollywood

    Hollywood, Florida, 33024

  • Houston Clinical Research Associates

    Houston, Texas, 77090

  • East Coast Institute for Research LLC at NE FL Endo & Diabetes

    Jacksonville, Florida, 32204

  • Solutions Through Advanced Research, Inc.

    Jacksonville, Florida, 32258

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Prime Care Clinical Research

    Laguna Hills, California, 92653

  • Accent Clinical Trials

    Las Vegas, Nevada, 89052

  • Clinical Research of South Nevada

    Las Vegas, Nevada, 89121

  • Torrance Clinical Research Institute Inc.

    Lomita, California, 90717

  • Baptist Diabetes Associates, PA

    Miami, Florida, 33156

  • International Research Associates

    Miami, Florida, 33183

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Family Medical Clinic

    Milwaukee, Wisconsin, 53216

  • Manhattan Medical Research Practice PLLC

    New York, New York, 10016

  • York Clinical Research, LLC

    Norfolk, Virginia, 23510

  • South Florida Research Solutions, LLC

    Pembroke Pines, Florida, 33026

  • Science Advancing Medicine Clinical Research Center

    San Antonio, Texas, 78229

  • Syed Research Consultants, LLC

    Sheffield, Alabama, 35660

  • Georgia Clinical Research, LLC

    Snellville, Georgia, 30078

  • Rowan Research, Inc.

    Spokane, Washington, 99218

  • Preferred Primary Care Phys

    Uniontown, Pennsylvania, 15401

  • Family Practice Center of Wadsworth, Inc.

    Wadsworth, Ohio, 44281

Other trials in United States

Japan32 sites

  • Daishinkai Medical Corporation Ookuma Hospital

    Aichi, Nagoya, 462-0825

  • Matsuyama Shimin Hospital

    Ehime, Matsuyama, 790-0067

  • Iryohojin Kikuchi Naika Clinic

    Gunma, Maebashi, 370-3573

  • Nakamura Digestive Organ Internal Medicine Clinic

    Hokkaido, Bibai, 072-0012

  • Iida Medical Clinic

    Hokkaido, Hakodate, 042-0942

  • Jiyugaoka Yamada Clinic

    Hokkaido, Obihiro, 080-0848

  • Shinkotoni family Clinic

    Hokkaido, Sapporo, 001-0912

  • Yoshida Memorial Hospital

    Hokkaido, Sapporo, 003-0026

  • Teine Keijinkai Clinic

    Hokkaido, Sapporo, 006-0811

  • Japan Community Health Care Organization Hokkaido Hospital

    Hokkaido, Sapporo, 062-8618

  • Itabashi Diabetic medicine and Dermatology Clinic

    Ibaraki, Koga, 306-0232

  • Nakakinen Clinic

    Ibaraki, Naka, 311-0113

  • Takai Naika Clinic

    Kanagawa, Kamakura, 247-0056

  • Kaneshiro DIAB Clinic, Kanagawa, I.M.

    Kanagawa, Sagamihara, 252-0302

  • Asahi Med. clinic, Kanagawa, I.M.

    Kanagawa, Yokohama, 221-0802

  • Ishikawa Med. Clinic, Kanagawa, I.M.

    Kanagawa, Yokohama, 241-0821

  • National Hospital Organization Yokohama Medical Center

    Kanagawa, Yokohama, 245-8575

  • Okayama Saiseikai General Hospital Outpatient Center

    Okayama, Okayama, 700-8511

  • AMC Nishi-umeda Clinic

    Osaka, Osaka, 530-0001

  • Nissay Hospital Nippon Life Saiseikai Public Interest Incorporated Foundation

    Osaka, Osaka, 550-0012

  • OCROM Clinic

    Osaka, Suita, 565-0853

  • Saga Memorial Hospital

    Saga, Saga, 849-0917

  • Asano Clinic

    Saitama, Kawagoe, 350-0851

  • Hamamatsu Rosai Hospital

    Shizuoka, Hamamatsu, 430-8525

  • Kuriyama Clinic

    Tokyo, Adachi-ku, 121-0064

  • The Institute for Adult Deseases, Asahi Life Foundation

    Tokyo, Chuo-ku, 103-0002

  • Tokyo-Eki Center-building Clinic

    Tokyo, Chuo-ku, 103-0027

  • Tokyo Center Clinic

    Tokyo, Chuo-ku, 103-0028

  • AGE Makita Medical Clinic

    Tokyo, Chuo-ku, 104-0061

  • Kobayashi Internal Medicine Clinic

    Tokyo, Koto-ku, 135-0011

  • Kunitachi Naika Clinic

    Tokyo, Kunitachi, 186-0002

  • Japanese Red Cross Medical Center

    Tokyo, Shibuya-ku, 150-8935

Other trials in Japan

Spain10 sites

  • Hospital A Coruña

    A Coruña, 15003

  • Instituto de Ciencias Médicas

    Alicante, 03004

  • Hospital Quiron. I.C.U.

    Barcelona, 08023

  • C.A.P. Sardenya

    Barcelona, 08025

  • CAP Les Corts

    Barcelona, 08028

  • CAP Canet de Mar

    Canet de Mar, 08360

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Nuestra Señora de Valme

    Seville, 41014

  • Hospital Clínico de Valencia

    Valencia, 46010

  • CAP El Remei

    Vic, 08500

Other trials in Spain

South Africa9 sites

  • TREAD Research

    Cape Town, 7500

  • Tiervlei Trial Centre

    Cape Town, 7530

  • Paarl Research Centre

    Cape Town, 7646

  • Soweto Clinical Trials Centre

    Johannesburg, 1818

  • LCS Clinical Research Unit

    Johannesburg, 2021

  • Resego Health Services

    Johannesburg, 2189

  • Zinakekele Medical Centre

    Kwamhlanga, 1022

  • Mzansi Ethical Research Centre

    Middleburg, 1055

  • VX Pharma (Pty) Ltd Pretoria

    Pretoria, 0087

Other trials in South Africa

Denmark8 sites

  • Aalborg Sygehus Syd

    Aalborg, 9100

  • Sydvestjyst Sygehus Esbjerg, Endokrinologisk afdeling

    Esbjerg, 6700

  • Frederiksberg Hospital, Endokrinologisk afd.

    Frederiksberg, 2000

  • Gentofte University Hospital

    Hellerup, 2900

  • Bispebjerg Hospital

    København NV, 2400

  • Køge Sygehus

    Køge, 4600

  • Kolding Sygehus

    Kolding, 6000

  • Roskilde Sygehus

    Roskilde, 4000

Other trials in Denmark

United Kingdom7 sites

  • The Haven Surgery

    Burnhope, DH7 0BD

  • South Axholme Practice

    Doncaster, DN9 2HY

  • Fowey Clinical Research Company Ltd

    Fowey, PL23 1DT

  • Oak Tree Surgery

    Liskeard, PL14 3XA

  • St. Mary's Hospital, Vectasearch Clinic, Newport

    Newport, PO309 5TG

  • Mounts Bay Medical Ltd

    Penzance, TR19 7HX

  • Rame Medical, Penntorr Health

    Torpoint, PL11 2TB

Other trials in United Kingdom

Germany6 sites

  • Gemeinschaftspraxis, Asslar

    Aßlar, 35614

  • ikfe - Institut für klinische Forschung und Entwicklung Berlin GmbH

    Berlin, 10115

  • Diabetologische Schwerpunktpraxis, Bosenheim

    Bosenheim, 55545

  • Dünnwaldpraxis, Köln

    Cologne, 51069

  • Praxis Dr. Naudts, Rodgau

    Rodgau, 63110

  • Praxis Dr. Braun, Unterschneidheim

    Unterschneidheim, 73485

Other trials in Germany

Greece6 sites

  • "Korgialeneio-Benakeio" Hellenic Red Cross Hospital

    Athens, 115 26

  • General Hospital of Athens "G. Gennimatas"

    Athens, 11527

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45500

  • General Hospital of Attiki "KAT-EKA"

    Kifissia, 14561

  • General Hospital of Nikaia

    Nikaia, 18454

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloniki, 57010

Other trials in Greece

Mexico6 sites

  • Investigación en Salud y Metabolismo S.C.

    Chihuahua City, 31217

  • Centro de At. e Inv.en Fact.de riesgo cardiovasc.Omega, S.C.

    México, 06400

  • Clinstile S.A. de C.V.

    México, 06700

  • CAIMED

    México, 06760

  • CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc

    México, C.P. 11650

  • Asociación Mexicana para la Investigacion Clínica, A.C(AMIC)

    Pachuca, 42070

Other trials in Mexico

Colombia5 sites

  • CEQUIN

    Armenia, 630004

  • Dexa Diabetes Servicios Médicos Ltda

    Bogotá, 110221

  • CAFAM Caja de Compensación Familiar

    Bogotá, 111211

  • Asociacion IPS Medicos Internistas de Caldas

    Manizales, 170004

  • Hospital Pablo Tobón Uribe

    Medellín, 050034

Other trials in Colombia

Finland4 sites

  • Keravan terveyskeskus

    Kerava, 04200

  • Terveystalo Oulu, Diapolis

    Oulu, FI-90100

  • Lääkärikeskus Aava, Turku

    Turku, 20520

  • TYKS

    Turku, FI-20520

Other trials in Finland

Australia3 sites

  • ECRU Maroondah

    East Ringwood, Victoria, 3135

  • Royal Brisbane & Women's Hospital-Endocrinology

    Herston, Queensland, 4029

  • AIM Centre

    Merewether, New South Wales, 2291

Other trials in Australia

New Zealand3 sites

  • Middlemore Clinical Trials

    Auckland, 2025

  • South Pacific Clinical Trials

    Auckland, New Zealand, 0610

  • Christchurch Hospital

    Christchurch, 8011

Other trials in New Zealand

Poland3 sites

  • Medicome Sp. z o.o.

    Oświęcim, 32-600

  • Omedica Centrum Medyczne

    Poznan, 60-111

  • NBR Polska

    Warsaw, 00-465

Other trials in Poland

Romania3 sites

  • Nicodiab SRL, Bucharest

    Bucharest, 010507

  • Pelican Impex SRL, Cabinet Nr. 15

    Oradea, 410469

  • Mediab SRL

    Târgu Mureş, 540142

Other trials in Romania

Belgium1 site

  • Ham - PRAC Mortelmans

    Oostham, 3945

Other trials in Belgium

Ireland1 site

  • Connolly Hospital Blanchardstown

    Dublin, Dublin 15

Other trials in Ireland

About this study

Official title: 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

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.

Being tested
placebo, linagliptin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

    placebo matching linagliptin 5 mg

  • linagliptinDrug

    5 mg once a day

Study groups in NCT02240680
Study groupRoleWhat they receive
linagliptin 5 mgExperimentalpatient to receive a tablet of linagliptin 5 mg each day
Receives: Drug: linagliptin
placeboPlacebo comparatorpatient to receive a tablet of placebo matching linagliptin 5 mg
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 24

Secondary outcomes (5)

  1. 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.

    Measured: 24 weeks

  2. 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.

    Measured: 24 weeks

  3. 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.

    Measured: 24 weeks

  4. 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.

    Measured: 24 weeks

  5. 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

    Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2014 (estimated)
  2. Study start23 Sep 2014
  3. Primary completion18 Apr 2017
  4. Study completion25 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02240680
Sponsor's protocol ID
1218.149
Other IDs
2014-000904-88, 2014
Status last verified
May 2018
First submitted
15 Sep 2014
Last updated
3 Jul 2018

Publications

  • 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.

    PubMed 31482511

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 145 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in United States, Japan, Spain, South Africa, Denmark and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment. (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02240680, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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