Patients with type 2 diabetes. MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Diagnosis of type 2 diabetes prior to informed consent. 2.Male and female patients with a diagnosis of type 2 diabetes mellitus and drug naive or pre-existing antidiabetic therapy (glitazones, insulin, acarbose, voglibose or any combinations of these) and a GFR=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 (no on the same day). 2.Myocardial infarction, stroke or TIA within 3 months prior to informed consent. 3.Renal impairment requiring any form of chronic dialysis. 4.Requiring acute dialysis in the past 3 months. 5.Planned or previous renal transplant recipient. 6.Bariatric surgery. 7.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. 8.Known hypersensitivity or allergy to the investigational product or its excipients or the patients’ baseline drug or placebo. 9.Known hypersensitivity or allergy to the sulfonlyureas, other sulfonamides or other components of the tablet. 10.Treatment with glimepride is considered inappropriate in the opinion of the investigator for safe participation in the study, taking into consideration the local Prescribing Information. 11.Treatment with any other DDP-4 inhibitor within 3 months prior to informed consent. 12.Treatment with GLP-1 analogues/agonist within 3 months prior to informed consent. 13.Treatment with sulfonylureas within 8 weeks prior to informed consent. 14.Treatment with glinides within 8 weeks prior to informed consent. 15.Treatment with metformin within 8 weeks prior to informed consent. 16.Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent. 17.Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse. 18.Participation in another trial with an investigational drug within 2 months prior to informed consent. 19.Pre-menopausal women (last menstruation ? 1 year prior to informed consent) who: - are nursing or pregnant, - or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, double barrier methods, surgical sterilization, sexual abstinence or vasectomised partner. 20.Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. 21.Hereditary galactose intolerance. 22.Patients considered unreliable by the investigator concerning the requirements for follow up during the study and/or compliance with study drug administration, has a life expectancy less than the expected duration of the trial due to concomitant disease, or has any condition which in the opinion of the investigator, would not allow safe participation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).;Secondary Objective: Secondary endpoints are the following: •The occurrence of a treat to target efficacy response, that is an HbA1c under treatment of <6.5% as well as <7.0% after 12 weeks of treatment •Occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 12 weeks of treatment) •Change from baseline in HbA1c by visit over time •The change from baseline in fasting plasma glucose (FPG) after 12 weeks of reatment •The change from baseline in fasting plasma glucose (FPG) by visit over time •Plasma concentration of linagliptin at trough after 12, 24 and 52 weeks of treatment •The composite of: - the occurrence of a treat to target response of HbA1c<7.0% after 52 weeks, - no weight gain (< 1 kg weight gain) after 52 weeks as compared to baseline (Visit 3) and - no investigator reported hypoglycaemia up to Week 52 ;Primary end point(s): The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment. Throughout the study protocol, the term "baseline" refers to the last observation prior to the randomised period. | — |
Countries
Finland, Slovakia, Sweden
Outcome results
None listed