NCT00789035已完成2 期
A Phase IIb, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (5 mg, 10 mg and 25 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo, as Monotherapy, With an Additional Open-label Metformin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 408
- 试验地点
- 106
- 主要终点
- Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment
研究概览
简要总结
The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed
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 80 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
- •either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose for the10 weeks prior to screening
- •HbA1c ≥6.5 to ≤9.0% and for treatment-naïve patients:HbA1c >7.0 to ≤10.0%
- •HbA1c >7.0 to ≤10.0% at Visit 2 (start of run-in) for all patients
- •Age between 18 and 80 years
- •BMI less than 40 kg/m2
- •Signed and dated informed consent prior to admission to the study in accordance with GCP and local legislation
排除标准
- •Myocardial infarction, stroke or TIA within 6 months prior to informed consent
- •Impaired hepatic function
- •Renal insufficiency or impaired renal function
- •Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation
- •Chronic or clinically relevant acute infections
- •Current or chronic urogenital tract infection determined by medical history
- •History of clinically relevant allergy/hypersensitivity
- •Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent
- •Treatment with anti obesity drugs
- •Current treatment with systemic steroids
- •Alcohol abuse
- •Treatment with an investigational drug within 2 months prior to informed consent
- •known intolerance to metformin
- •Dehydration
- •Unstable or acute CHF
- •Acute or chronic acidosis
- •Hereditary galactose intolerance
- •Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control
结局指标
主要结局
Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment
时间窗: Baseline and 12 weeks
Change of HbA1c from baseline after 12 weeks of treatment. Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.
次要结局
- Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)(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)
- Change of HbA1c From Baseline Over Time(Baseline and weeks 4, 8 and 12)
- Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment(12 weeks)
- Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment(12 weeks)
- Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)(Baseline and 12 weeks)
- Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)(Baseline and 12 weeks)
- Change of FPG From Baseline After 12 Weeks of Treatment(Baseline and 12 weeks)
研究者
研究点 (106)
Loading locations...
相似试验
已完成
3 期
Phase III Study of Coagulation FVIIa (Recombinant) in Congenital Hemophilia A or B Patients With InhibitorsHemophilia A With InhibitorsHemophilia B With InhibitorsNCT02020369rEVO Biologics27
已完成
3 期
A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIaHemophilia A With InhibitorsHemophilia B With InhibitorsNCT02448680Laboratoire français de Fractionnement et de Biotechnologies25
已完成
2 期
Clazosentan in Preventing the Occurrence of Cerebral Vasospasm Following an Aneurysmal Subarachnoid Hemorrhage (aSAH)Aneurysmal Subarachnoid HemorrhageNCT00111085Idorsia Pharmaceuticals Ltd.413
已完成
2 期
Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of Mitoglitazone in Type 2 Diabetic PatientsType 2 DiabetesNCT01103414Metabolic Solutions Development Company356
已完成
2 期
A Study of Acute Myocardial Infarction Using FDY-5301Acute Myocardial InfarctionSTEMINCT03470441Faraday Pharmaceuticals, Inc.120