NCT00749190已完成2 期
A Phase II, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (1 mg, 5 mg, 10 mg, 25 mg, and 50 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo With an Additional Open-label Sitagliptin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control Despite Metformin Therapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 495
- 试验地点
- 159
- 主要终点
- Change From Baseline in HbA1c After 12 Weeks of Treatment
研究概览
简要总结
The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
- •Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose.
- •HbA1c at screening 6.5% to 9.0% for patients on metformin and one other antidiabetic drug, and HbA1c >7.0% to 10% for patients on metformin only
- •HbA1c >7.0% to 10.0% at Visit 2 (Start of Run-in)
- •Age >=18 and <80years
- •Body Mass Index (BMI) <=40 kg/m2
- •Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
排除标准
- •Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
- •Impaired hepatic function
- •Renal insufficiency or impaired renal function
- •Diseases of the central nervous system or psychiatric disorders or clinically relevant neurological disorders that may interfere with participation in the trial
- •Chronic or clinically relevant acute infections
- •Current or chronic urogenital tract infection
- •History of clinically relevant allergy/hypersensitivity
- •Treatment with glitazones (e.g., rosiglitazone, pioglitazone), glucagon-like peptide (GLP-1) analogues, or insulin within 3 months prior to informed consent
- •Treatment with anti-obesity drugs within 3 months prior to informed consent
- •Treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent
- •Alcohol abuse or drug abuse
- •Treatment with an investigational drug within 2 months prior to informed consent
- •Women of child-bearing potential who are nursing or pregnant, or who 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 periodic pregnancy testing during participation in the trial
结局指标
主要结局
Change From Baseline in HbA1c After 12 Weeks of Treatment
时间窗: Baseline and 12 weeks
Change from baseline in HbA1c after 12 weeks of treatment. In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.
次要结局
- Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)(Baseline and 12 weeks)
- Change of Body Weight After 12 Weeks of Treatment(Baseline and 12 weeks)
- Trough Concentrations of Empagliflozin in Plasma(Days 28, 56 and 84)
- Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment(Baseline and 12 weeks)
- Change of FPG From Baseline After 12 Weeks of Treatment(Baseline and 12 weeks)
- Change of HbA1c From Baseline Over Time(Baseline and weeks 4, 8 and 12)
- Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment(Baseline and 12 weeks)
- Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)(Baseline and 12 weeks)
- Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)(Baseline and 12 weeks)
研究者
研究点 (159)
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