Linagliptin as Add on to Basal Insulin in the Elderly
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: placebo; linagliptin
Intervention description: placebo matching linagliptin 5 mg; 5 mg once a day
Intervention MeSH terms: Linagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 302.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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).