EUCTR2006-002311-27-CZ进行中（未招募）不适用
A randomized, double-blind, placebo-controlled, five parallel group study investigating the efficacy and safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg administered orally once daily) over 12 weeks in drug naïve and treated patients with Type 2 diabetes with insufficient glycemic control (study includes an open-label metformin treatment arm)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 375
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male and female patients with diagnosis of Type 2 diabetes treated only with diet and exercise ( drug naïve) or with one or two oral hypoglycemic agents ( as single treatment or in combination ) other than rosiglitazone or pioglitazone – treatment. Antidiabetic therapy has to be stable for at least 10 weeks prior to screening.
- •2.Diagnosis of Type 2 diabetes with duration of at least 3 month.
- •3.Glycosilated haemoglobin A1 ( HbA1c) of:
- •-7.5-10.0% at screening for drug naïve patients ( no wash-out needed)
- •-7.0-9.0% at screening for patients treated with only one oral antidiabetic agent ( wash-out required)
- •-6.5-8.0% at screening for patients treated with two oral antidiabetic agents ( wash-out required)
- •4.HbA1c of 7.5%-10.0% at visit 3 ( beginning of the 2-week placebo run-in period)
- •5.Age =21 and = 75 years
- •6.BMI ( Body Mass index) = 25.0 and = 40 kg/m2.
- •7.Signed and dated written informed consent prior to admission to the study in accordance with GCP and local regislation.
- •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
排除标准
- •1.Clinically relevant cardiovascular disease ( e.g. myocardial infarction, stroke or TIA within six month before enrolment)
- •2.Impaired hepatic function defined by serum levels of either ALT ( SGPT), AST ( SGOT) or alkaline phosphatase above 3-fold upper limit of normal
- •3.Renal insufficiency or impaired renal function defined by serum creatinine above upper limit of normal screening
- •4.Disease of the central nervous system ( such as epilepsy) or psychiatric disorders or clinically relevant neurologic disorders ( including cerebrovascular but with the exception of polyneuropathy) that would interfere with participation in the trial.
- •5.Chronic or clinically relevant acute infections ( e.g., HIV, Hepatitis)
- •6.History of relevant allergy/hypersensitivity that would interfere with trial participation ( including allergy to investigational product or its excipients)
- •7.Treatment with rosiglitazone or pioglitazone within 6 month prior to screening
- •8.Treatment with insulin within 3 month prior to screening
- •9.Alcohol or drug abuse within the last 3 month that would interfere with trial participation
- •10.Participation in another trial with an investigational drug within two month prior to administration or during the trial
- •11.Fasting plasma glucose > 240 mg/dl (=13.3 mmol/L) at Visits 2, 3 or 4 any visit and confirmed by a second measurement ( not the same day)
- •12.Pre-menopausal women ( last menstruation = year prior to signing informed consent) who:
- •-are not surgically sterile
- •-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 ( IUDs), oral, implantable or injectable contraceptives and vasectomised partner. No exception will be made.
- •13.Intolerance of metformin.
研究者
相似试验
招募中
不适用
A randomized, double-blind, placebo-controlled, first-in-human phase 1 study evaluating safety, tolerability, and pharmacokinetics of single ascending doses of SOL-116 (a humanized monoclonal anti-BSSL antibody) in healthy subjects and patients with rheumatoid arthritis.rheumatoid arthritis (RA)10003816NL-OMON56208ipum AB72
进行中（未招募）
不适用
A randomised, double-blind, placebo-controlled, five parallel groups efficacy and safety exploratory study comparing BI 1356 BS (1mg, 5mg and 10mg) to open label glimepiride each administered orally once daily over 12 weeks as add-on therapy in patients with type 2 diabetes and insufficient glycaemic control despite metformin therapyPatients with type 2 diabetesMedDRA version: 8.1Level: PTClassification code 10012613EUCTR2005-004597-24-DEBoehringer Ingelheim Pharma GmbH & Co. KG375
已完成
不适用
A double-blind, randomized, placebo-controlled, five-way cross-over interaction trial to investigate the inhibitory effect of olanzapine on a THC-induced increase on the Positive and Negative Syndrome ScalePsychosisPsychotic disorder10039628NL-OMON33219Centre for Human Drug Research40
已完成
不适用
A randomized, double-blind, placebo controlled, first in human study to investigate the safety, tolerability, and pharmacokinetic and pharmacodynamic response of SLN360 in subjects with elevated lipoprotein (a)atherosclerosisNL-OMON55119Silence Therapeutics plc18
进行中（未招募）
不适用
A randomised, double-blind, placebo-controlled, four-way crossover, repeat dose study comparing the effect of inhaled fluticasone furoate/GW642444M combination, GW642444M and fluticasone furoate on the allergen-induced asthmatic response in subjects with mild asthma.subjects with mild asthmaMedDRA version: 12.1Level: LLTClassification code 10003553Term: AsthmaEUCTR2010-019465-28-SEGlaxoSmithKline Research & Development Ltd24