Type 2 diabetes with insufficient glycaemic control (HbA1c 7.0-10%) despite background therapy with a sulfonylurea drug MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Product Name: BI 1356
Product Code: BI 1356
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: linagliptin
CAS Number: 668270-12-0
Current Sponsor code: BI 1356
Concentration unit: mg millig
Sponsors
Boehringer Ingelheim RCV GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with sulfonylurea drug alone or with not more than one other antidiabetic drug • Antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent and patients should receive standard diet and exercise counselling • Sulfonylurea dose of at least ½ the maximum dose (or less if documented as maximum tolerated dose of at least 12 weeks) • Diagnosis of type 2 diabetes prior to informed consent • HbA1c at Visit 1a (Screening): o For patients undergoing wash out of previous medication: HbA1c =7.0 to =9.0% o For patients not undergoing wash-out of previous medication: HbA1c =7.5 to =10.0% • Glycosylated haemoglobin A1 (HbA1c) =7.5 to =10 % at Visit 2 (Start of Run in) • Age 18-80 years at Visit 1a (Screening) • BMI (body mass index) =40 kg/m2 at Visit 1a (Screening) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: • Myocardial infarction, stroke or TIA within 6 months prior to informed consent • Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN), or elevated total bilirubin above 3xULN, as determined at Visit 1a • Known hypersensitivity or allergy to the investigational product or its excipients or the patients’ sulfonylurea drug or placebo • Treatment with thiazolidinediones (e.g., rosiglitazone, pioglitazone) within 3 months prior to informed consent • Treatment with an injectable GLP-1 analogue (e.g., exenatide) within 3 months prior to informed consent • Chronic daily treatment with insulin within 3 months prior to informed consent • Treatment with anti-obesity drugs (e.g., sibutramine, orlistat, rimonabant) within 3 months prior to informed consent • Alcohol abuse or drug abuse within the 3 months prior to informed consent that would interfere with trial participation. • Participation in another trial with an investigational drug within 2 months prior to informed consent • 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, sexual abstinence, double barrier method, female surgical sterilization, or vasectomised partner. • Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. • Renal failure or renal impairment (calculated glomerular filtration rate [GFR] <30 mL/min as determined at Visit 1a) • Unstable or acute congestive heart failure • Hereditary galactose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • HbA1c change from baseline at 18 weeks ;Secondary Objective: • Fasting plasma glucose (FPG) change from baseline at 18 weeks • Occurrence of a treat-to-target response (i.e., an HbA1c during treatment of <7.0%) • Occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 18 weeks of treatment) • HbA1c reduction from baseline by visit over time • The change from baseline in fasting plasma glucose (FPG) by visit over time • The occurrence of treat to target efficacy response, that is an HbA1c under treatment of <6.5% after 18 weeks of treatment ;Primary end point(s): change from baseline in HbA1c (HbA1c after 18 weeks of treatment) | — |
Countries
Hungary
Outcome results
None listed