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
- diabetesDiabetes mellitus type 210018424
- Registration Number
- NL-OMON34800
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
(see page 18 of the protocol for the complete list)
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
(see page 19 of the protocol for the complete list)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy: change in HbA1c after 24 weeks of treatment<br /><br>Safety: (serious) adverse events; hypoglycemic events; significant events;<br /><br>cardiovascular events; change in: ECG, vital signs, labparameters, background<br /><br>medication; use of rescue medication.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Occurrence of HbA1c <7.0% or decrease of >=0.5% after 24 weeks of treatment;<br /><br>change in HbA1c each visit; change in fasting plasma glucose after 24 weeks of<br /><br>treatment; change in fasting plasma glucose each visit.</p><br>