CTRI/2011/091/000060招募中3 期
A phase III, randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of BI 10773 (10 mg and 25 mg administered once daily) as add on to pre-existing antidiabetic therapy over 52 weeks in patients with type 2 diabetes mellitus and renal impairment and insufficient glycaemic control
Boehringer Ingelheim Pharmaceuticals16 个研究点 分布在 1 个国家目标入组 682 人开始时间: 2011年4月3日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 682
- 试验地点
- 16
- 主要终点
- Change from baseline in HbA1c after 24weeks of treatment
研究概览
简要总结
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 (10 mg and 25 mg / once daily) compared to placebo given for 52 weeks as add-on therapy to pre-existing antidiabetic therapy in patients with type 2 diabetes with insufficient glycaemic control and renal impairment.Approximately 125 trial sites from 16 countries will participate in this study. Approximately 150 patients will be recruited in India from 13 sites. The first patient from India is expected to be screened on 28 Jan 2011
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
入选标准
- •Diagnosis of type 2 diabetes mellitus prior to informed consent and a eGFR of <90 ml/min, as determined during screening and the run-in phase, using the Modification of Diet in Renal Disease (MDRD) equation.
- •Male and female patients on diet and exercise regimen who are pre-treated with any antidiabetic therapy (excluding only SGLT-2 inhibitors) and are on the maximum tolerated dose which has been unchanged for 12 weeks prior to randomisation.?
- •Metformin therapy should be ≥ 1500 mg/day or on the maximum tolerated dose or maximum dose according to local labelling?
- •The prescribed insulin dose should not be changed within the 12 weeks prior to randomisation by +/- 10% from the baseline value at randomisation?
- •Pioglitazone therapy should be ≥30 mg/day or maximum dose according to local labelling?
- •Sulphonylurea therapy should be ≥half the recommended maximal dose according to local labelling.
- •HbA1c of ≥7.0% and <10.0% at Visit 1 (screening).
- •Age ≥18 years (Restricted to patients <= 65 years of age as per upper age limit imposed by the DCG(I) for patients recruited in India).
- •BMI ≤45 kg/m2 (Body Mass Index) at Visit 1 (screening).
- •Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation.
排除标准
- •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).
- •Impaired renal function, defined as eGFR<15 ml/min using the MDRD equation as determined during screening and/or the run-in phase.
- •Renal impairment requiring any form of chronic dialysis.
- •Requiring acute dialysis within three months prior to informed consent.
- •Renal transplant recipient.
- •Myocardial infarction, stroke or Transient Ischemic Attack (TIA) within three months prior to informed consent.
- •Indication of liver disease, defined by serum levels of either Alanine transaminase (ALT) (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) asdetermined during screening and/or the run-in phase.
- •Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
- •Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last five years.
- •Blood dyscrasias or any disorders causing hemolysis or unstable red blood cell (e.g. malaria, babesiosis, haemolytic anemia).
- •Contraindications to pre-existing background antidiabetic therapy according to the local label.
- •Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) three months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
- •Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within six weeks prior to informed consent or any other uncontrolledendocrine disorder except T2DM.
- •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 practising 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 tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.
- •Alcohol or drug abuse within the three months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.
- •Participation in another trial with an investigational drug within 30 days prior to informed consent.
- •Any other clinical condition that would jeopardize patients safety while participating in this clinical trial.
结局指标
主要结局
Change from baseline in HbA1c after 24weeks of treatment
时间窗: Baseline and 24 Weeks
次要结局
- Change from baseline in FPG after 24 and 52 weeks of treatmen(Baseline, 24 Weeks and 52 Weeks)
- Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 24 and 52 weeks of treatment(Baseline, 24 Weeks and 52 Weeks)
- Change from baseline in HbA1c after 52 weeks of treatment(Baseline and 52 Weeks)
- Occurrence of relative efficacy response (HbA1c lowering by a least 0.5% after 24 and 52 weeks of treatment(Baseline, 24 Weeks and 52 Weeks)
- Body weight and waist circumference: Change from baseline to week 24 and 52(Baseline, 24 Weeks and 52 Weeks)
- Systolic and diastolic BP: Change from baseline to week 24 and 52.(Baseline, 24 Weeks and 52 Weeks)
- Change from baseline in HbA1c by visit over time(Ongoing)
- Change from baseline in FPG by visit over time(Ongoing)
研究者
研究点 (16)
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