Patients with type 2 diabetes. MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Boehringer Ingelheim bv
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients with diagnosis of T2DM and stable treatment prior to informed consent. Treatment with metformin and/or sulphonylurea has to be unchanged for 8 weeks prior to informed consent; the insulin dose should not have changed within the 8 weeks prior to informed consent by more than 20% from the baseline value at randomisation. 2. Glycosylated haemoglobin A1 (HbA1c) >= 7.0 % at Visit 1 3. Age >= 70 years at Visit 1 4. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day). 2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent 3. Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1 4. Bariatric surgery 5. Known hypersensitivity or allergy to the investigational product or its excipients or the patients’ baseline drug(s) or placebo 6. Treatment with glitazones, GLP-1 analogues or DPP-4 inhibitors within 3 months prior to informed consent 7. Treatment with rapid acting or pre-mixed insulins 8. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent 9. Active alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation 10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. 11. Participation in another trial with an investigational drug within 2 months prior to informed consent 12. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol or study related procedures 13. Illness or concomitant disease/condition that may increase the risk associated with study participation and in the judgement of the investigator would make the patient inappropriate for entry into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the current trial is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to stable treatment in elderly patients with T2DM with insufficient glycaemic control;Secondary Objective: This trial does not have any secondary objective;Primary end point(s): The primary endpoint in this study is the change from baseline in HbA1c after 24 weeks of treatment. Throughout the study protocol, the term "baseline" refers to the last observation prior to the randomised period. | — |
Countries
Denmark, Netherlands, Sweden
Outcome results
None listed