Linagliptin as Add on to Basal Insulin in the Elderly



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:60 - Any
Updated:7/5/2018
Start Date:September 23, 2014
End Date:April 25, 2017

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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.


Inclusion criteria:

- 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.

Exclusion criteria:

- 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).
We found this trial at
39
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3801 N. Fairfax Drive
Arlington, Virginia 22203
703-527-8100
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8200 SW 117th Ave # 210
Miami, Florida 33183
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1616 East Pleasant Valley Boulevard
Altoona, Pennsylvania 16602
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Arlington, Texas 76012
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Avon, Indiana
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425 Medical Drive
Bountiful, Utah 84010
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Chula Vista, California 91910
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2875 International Circle
Colorado Springs, Colorado 80910
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Columbia, South Carolina 29204
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Costa Mesa, California 92627
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Crystal Lake, Illinois 60012
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9 Medical Parkway
Dallas, Texas 75234
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15300 Jog Road
Delray Beach, Florida 33446
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Edgewater, Florida 32132
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805 North Richmond Street
Fleetwood, Pennsylvania 19522
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3410 Cokesbury Road
Hodges, South Carolina 29653
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Hollywood, Florida 33024
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6550 Fannin Street
Houston, Texas 77090
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Kingsport, Tennessee 37660
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Laguna Hills, California 92653
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Las Vegas, Nevada 89106
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Las Vegas, Nevada 89121
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41 Llewellyn Street
Merewether, New South Wales 2291
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Miami, Florida 33156
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Miami Lakes, Florida 33014
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Milwaukee, Wisconsin 53216
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New York, New York 10016
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142 West York Street
Norfolk, Virginia 23510
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Pembroke Pines, Florida 33028
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7979 Wurzbach Road
San Antonio, Texas 78229
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342 Cox Boulevard
Sheffield, Alabama 35660
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Snellville, Georgia 30078
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Spokane, Washington 99207
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104 McClellandtown Road
Uniontown, Pennsylvania 15401
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