CTRI/2010/091/001474已完成3 期
A randomised, double-blind, placebo-controlled parallel group efficacy and safety trial of BI 10773 (10 and 25 mg administered orally once daily) over 24 weeks in patients with type 2 diabetes mellitus with insufficient glycaemic control despite a background therapy of pioglitazone alone or in combination with metformin
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 468
- 试验地点
- 17
- 主要终点
- The change from baseline in HbA1c
研究概览
简要总结
This is a randomised, double-blind, placebo-controlled parallel group comparison Randomisation will be stratified by background therapy, HbA1c at Visit 1 and by renal function at Visit 1 (normal renal function eGFR ≥ 90 ml/min, mild impairment eGFR 60-89 ml/min and moderate renal impairment eGFR 30-59 ml/min). The objective of the current trial is to investigate the efficacy, safety and tolerability of BI 10773 (10 and 25 mg once daily) compared to placebo given for 24 weeks as add-on therapy to pioglitazone alone or in combination with metformin in patients with type 2 diabetes mellitus (T2DM) with insufficient glycaemic control. Approximately 220 patients will be recruited from India for 18 sites. The first patient from India in this study will be enrolled on 29 October 2010.
Trial is completed. Results will be updated in due course of time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of type 2 diabetes mellitus prior to informed consent.
- •Male and female patients on diet and exercise regimen who are pre-treated with pioglitazone alone or in combination with metformin.
- •The treatment regimen should be unchanged for 12 weeks prior to randomisation.
- •HbA1c of greater than or equal to 7.0% and less that or equal to 10.0% at Visit 1 (screening).
- •Age greater than or equal to 18 and less than or equal to
- •BMI less than or equal to kg per 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)
- •Any other antidiabetic medication within 12 weeks prior to randomisation, except those defined as the permitted background therapy via inclusion criteria no. 2
- •Myocardial infarction, stroke or transient ischaemic attack (TIA) within 3 months prior to informed consent
- •Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3)
- •Impaired renal function, defined as eGFR (estimated Glomerular Filtration Rate) 30 ml/min (severe renal impairment, MDRD [Modification of Diet in Renal Disease] formula) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3)
- •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 5 years
- •Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia)
- •Contraindications to pioglitazone according to the local label
- •Contraindication to pioglitazone and/or metformin (relevant only for those patients who enter the study with both these background therapies) according to the local labels
- •Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 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 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2D
- •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 trial 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 to local authorities), double barrier method and vasectomised partner
- •Alcohol or drug abuse within the 3 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 jeopardise patient safety while participating in this clinical trial.
结局指标
主要结局
The change from baseline in HbA1c
时间窗: Baseline and 24 weeks
次要结局
- The change from baseline in fasting plasma glucose (FPG)(Baseline and 24 weeks)
研究者
研究点 (17)
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