NCT01871428已完成3 期
A Multicenter, Randomized, Doubleblind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Monotherapy Compared With Placebo in Patients With Type 2 Diabetes Mellitus (T2D) Who Are Drug-Naïve to Antihyperglycemic Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Change in HbA1c
研究概览
简要总结
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar monotherapy in patients with Type 2 diabetes mellitus who are drug-naïve to anti-hyperglycemic therapy. Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient, >/= 18 years of age
- •Diagnosis of Type 2 diabetes mellitus within 12 months prior to screening
- •Drug-naïve (defined as no anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months at any time in the past)
- •HbA1c >/= 7% and </= 9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
- •Fasting plasma glucose </= 13.3 mmol/L (</= 240 mg/dL) at pre-randomization visit
- •Agreement to maintain diet and exercise habits implemented during the run-in phase during the full course of the study
排除标准
- •Pregnant women, women intending to become pregnant during the study period, currently lactating women, or women of child-bearing potential not using highly effective, medically approved birth control methods
- •Diagnosis or history of:
- •Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- •Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
- •Any previous treatment with thiazolidinedione or with a dual peroxisome proliferator activated receptor (PPAR) agonist
- •Any body weight lowering or lipoprotein-modifying therapy (e.g. fibrates) within 12 weeks prior to screening with the exception of stable (>= 1 month) statin therapy
- •Prior intolerance to fibrate
- •Triglycerides (fasting) > 4.5 mmol/L (> 400 mg/dL) at screening or within 4 weeks prior to screening
- •Clinically apparent liver disease
- •Anemia at or within 4 weeks prior to screening
- •Inadequate renal function
- •Symptomatic congestive heart failure New York Heart Association (NYHA) Class II-IV at screening
- •Myocardial infarction, acute coronary syndrome or transient ischemic attack/stroke within 6 months prior to screening visit
- •Known macular edema at screening or prior to screening visit
- •Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
- •Uncontrolled hypertension
- •History of active substance abuse (including alcohol) within the past 2 years
研究组 & 干预措施
Aleglitazar
Experimental
干预措施: aleglitazar (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: from baseline to Week 26
次要结局
- Change in lipids(from baseline to Week 26)
- Change in fasting plasma glucose (FPG)(from baseline to Week 26)
- Responder rates, defined as target HbA1c: < 7.0%, < 6.5% at Week 26(26 weeks)
- Change in homeostatic index of insulin sensitivity (by Homeostasis Model Assessment for Insulin Sensitivity [HOMA-IS])(from baseline to Week 26)
- Change in homeostatic index of beta cell function (by HOMA-BFC)(from baseline to Week 26)
- Change in markers of insulin sensitivity/cardiovascular risk(from baseline to Week 26)
- Safety: Incidence of adverse events(approximately 30 weeks)
研究者
相似试验
已完成
3 期
A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin MonotherapyDiabetes Mellitus Type 2NCT01871415Hoffmann-La Roche7
终止
2 期
Study of RO6807952 in Patients With Diabetes Mellitus Type 2Diabetes Mellitus Type 2NCT01516476Hoffmann-La Roche2
撤回
3 期
To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)Refractory Status EpilepticusNCT05814523Marinus Pharmaceuticals
已完成
3 期
Efficacy and Safety Study of GB-0998 for Treatment of Systemic SclerosisScleroderma, SystemicNCT00348296Benesis Corporation60
已完成
3 期
A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin AloneDiabetes Mellitus Type 2NCT01691846Hoffmann-La Roche200