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Completed Phase 4 Interventional Results available

Linagliptin as Add on to Basal Insulin in the Elderly

ClinicalTrials.gov ID: NCT02240680

Public ClinicalTrials.gov record NCT02240680. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 5:09 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02240680
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
302 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
60 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 23, 2014 (Actual)
Primary completion
Apr 18, 2017 (Actual)
Completion
Apr 25, 2017 (Actual)
Last update posted
Jul 3, 2018

2014 – 2017

United States locations

U.S. sites
38
U.S. states
18
U.S. cities
35
Facility City State ZIP Site status
Syed Research Consultants, LLC Sheffield Alabama 35660 —
Precision Research Institute, LLC Chula Vista California 91910 —
Aurora Care Clinic, LLC Costa Mesa California 92627 —
Prime Care Clinical Research Laguna Hills California 92653 —
Torrance Clinical Research Institute Inc. Lomita California 90717 —
Internal Medicine of the Rockies Colorado Springs Colorado 80910 —
Cohen Medical Research Associates, LLC Delray Beach Florida 33446 —
Riverside Clinical Research Edgewater Florida 32132 —
Clinical Research of Hollywood Hollywood Florida 33024 —
East Coast Institute for Research LLC at NE FL Endo & Diabetes Jacksonville Florida 32204 —
Solutions Through Advanced Research, Inc. Jacksonville Florida 32258 —
Baptist Diabetes Associates, PA Miami Florida 33156 —
International Research Associates Miami Florida 33183 —
Panax Clinical Research Miami Lakes Florida 33014 —
South Florida Research Solutions, LLC Pembroke Pines Florida 33026 —
Georgia Clinical Research, LLC Snellville Georgia 30078 —
Midwest Endocrinology Crystal Lake Illinois 60012 —
American Health Network Avon Indiana 46123 —
Accent Clinical Trials Las Vegas Nevada 89052 —
Clinical Research of South Nevada Las Vegas Nevada 89121 —
Manhattan Medical Research Practice PLLC New York New York 10016 —
Family Practice Center of Wadsworth, Inc. Wadsworth Ohio 44281 —
Clinical Research Associates of Central Pennsylvania Altoona Pennsylvania 16602 —
Fleetwood Clinical Research Fleetwood Pennsylvania 19522 —
Preferred Primary Care Phys Uniontown Pennsylvania 15401 —
TLM Medical Services, LLC Columbia South Carolina 29204 —
Advanced Research Associates Hodges South Carolina 29653 —
Holston Medical Group Kingsport Tennessee 37660 —
Arlington Family Research Center, Inc. Arlington Texas 76012 —
Renaissance Clinical Research and Hypertension of Texas Dallas Texas 75234 —
Diabetes and Thyroid Center of Fort Worth Fort Worth Texas 76132 —
Houston Clinical Research Associates Houston Texas 77090 —
Science Advancing Medicine Clinical Research Center San Antonio Texas 78229 —
Office of Dr. Val R. Hansen Bountiful Utah 84010 —
Millennium Clinical Trials LLC Arlington Virginia 22203 —
York Clinical Research, LLC Norfolk Virginia 23510 —
Rowan Research, Inc. Spokane Washington 99218 —
Family Medical Clinic Milwaukee Wisconsin 53216 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 107 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02240680, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 3, 2018 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02240680 live on ClinicalTrials.gov.

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