Linagliptin as Add on to Basal Insulin in the Elderly

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT02240680

Run by

Boehringer Ingelheim

People needed

302

Starts

2014-09-23

Expected to finish

2017-04-25

Last updated by the study team

2018-07-03

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

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:
• 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)].
• 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).

Where it is running

• Precision Research Institute, LLC — Chula Vista, California, United States
• Aurora Care Clinic, LLC — Costa Mesa, California, United States
• Prime Care Clinical Research — Laguna Hills, California, United States
• Torrance Clinical Research Institute Inc. — Lomita, California, United States
• Internal Medicine of the Rockies — Colorado Springs, Colorado, United States
• Cohen Medical Research Associates, LLC — Delray Beach, Florida, United States
• Riverside Clinical Research — Edgewater, Florida, United States
• Clinical Research of Hollywood — Hollywood, Florida, United States
• East Coast Institute for Research LLC at NE FL Endo & Diabetes — Jacksonville, Florida, United States
• Solutions Through Advanced Research, Inc. — Jacksonville, Florida, United States
• Baptist Diabetes Associates, PA — Miami, Florida, United States
• International Research Associates — Miami, Florida, United States
• Panax Clinical Research — Miami Lakes, Florida, United States
• South Florida Research Solutions, LLC — Pembroke Pines, Florida, United States
• Georgia Clinical Research, LLC — Snellville, Georgia, United States
• Midwest Endocrinology — Crystal Lake, Illinois, United States
• American Health Network — Avon, Indiana, United States
• Accent Clinical Trials — Las Vegas, Nevada, United States
• Clinical Research of South Nevada — Las Vegas, Nevada, United States
• Manhattan Medical Research Practice PLLC — New York, New York, United States
• Family Practice Center of Wadsworth, Inc. — Wadsworth, Ohio, United States
• Clinical Research Associates of Central Pennsylvania — Altoona, Pennsylvania, United States
• Fleetwood Clinical Research — Fleetwood, Pennsylvania, United States
• Preferred Primary Care Phys — Uniontown, Pennsylvania, United States
• Syed Research Consultants, LLC — Sheffield, Alabama, United States

Full record on ClinicalTrials.gov

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