CTRI/2010/091/001299已完成3 期
A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orallly, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Suflonylurea
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,390
- 试验地点
- 5
- 主要终点
- The change from baseline in HbA1c after 24 weeks.
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, 25 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with T2DM with insufficient glycaemic control. Open-label arm: to estimate efficacy and safety of 25 mg BI 10773 in very poorly controlled patients (HbA1c > 11%). Approximately 150 trial sites from 12 countries will participate in this study. Approximately 128 patients will be recruited from India from 5 sites. The first patient from India is expected to be screened on 20 October 2010.
The trial is completed. The findings will be provided in due course of time once available.
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 a diet and exercise regimen who are pre treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses).
- •The treatment regimen has to be unchanged for 12 weeks prior to randomisation.
- •Minimum dose for metformin: greater than or equal to 1500 mg per day or maximum tolerated dose or maximum dose according to local label Minimum dose for sulfonylurea: greater than or equal to half of the maximal recommended dose or maximum tolerated dose or maximum dose according to local label
- •HbA1c of greater than or equal to 7.0 per cent and less than or equal to 11 per cent at Visit 1 (screening) in order to be eligible for randomised treatment HbA1c of greater than 11 per cent at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773)
- •Age in between 18 and 65
- •Body Mass Index BMI less than or equal to 45 kg per meter square (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 greater than 240 mg per dl (greater than 13.3 mmol per L) after an overnight fast during placebo run in and confirmed by a second measurement (not on the same day)
- •Any other antidiabetic drug within 12 weeks prior to randomisation except those mentioned in inclusion criterion 2
- •Myocardial infarction, stroke or transient ischemic 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 times upper limit of normal (ULN) as determined during screening and/or run-in phase
- •Impaired renal function, defined as eGFR less than 30 ml per min (severe renal impairment) as determined during screening and/or 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 5 years
- •Contraindications to metformin and/or sulfonylurea according to the local label for those patients that enter the study with the respective background therapy
- •Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
- •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 Typ 2 Diabetes
- •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 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 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 jeopardize patients safety while participating in this clinical trial.
结局指标
主要结局
The change from baseline in HbA1c after 24 weeks.
时间窗: 24 weeks
次要结局
- The mean daily plasma glucose (MDG) change from baseline after 24 weeks of treatment.(24 weeks)
- The change in HbA1c and FPG by visit over time(24 weeks)
- The composite endpoint of the following conditions at week 24: HbA1c lowering by a least 0.5%, lowering of systolic blood pressure by at least 3 mm Hg and decrease in body weight by more than 2%.(24 weeks)
- The body weight (kg) change from baseline after 24 weeks.(24 weeks)
- Occurrence of a treat to target response, (i.e. an HbA1c under treatment of < 7.0%)(24 weeks)
- Occurrence of relative efficacy response (HbA1c lowering by at least 0.5%)(24 weeks)
- The change in fasting plasma glucose (FPG), waist and systolic and diastolic blood pressure from baseline to week 24(24 weeks)
研究者
研究点 (5)
Loading locations...
相似试验
Unknown
3 期
Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a SulfonylureaType 2 DiabetesNCT01257334Taipei Medical University WanFang Hospital1,390
招募中
3 期
Efficacy and Safety of BI 10773 in Patients With Type 2 Diabetes and Renal ImpairmentCTRI/2011/091/000060Boehringer Ingelheim Pharmaceuticals682
已完成
2 期
Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT01011868Boehringer Ingelheim494
已完成
3 期
Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT01177813Boehringer Ingelheim986
已完成
3 期
Efficacy and Safety of BI 10773 With Metformin in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2CTRI/2010/091/001212Boehringer Ingelheim Pharmaceuticals1,400