A phase III randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of linagliptin (5 mg), administered orally once daily over 24 weeks in type 2 diabetic patients (age = 70 years) with insufficient glycaemic control (HbA1c = 7.0) despite metformin and/or sulphonylurea and/or insulin therapy

• Conditions: Patients with type 2 diabetes.; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2009-015255-25-NL
• Lead Sponsor: Boehringer Ingelheim bv

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-29
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 480

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified