NCT02227875已完成3 期
An Open-label, Randomized, Multi-center, Parallel Group Clinical Trial Comparing the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Change in HbA1c From Baseline to 24 Weeks
研究概览
简要总结
To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily (both administered in combination with other anti-diabetic drugs) based on the change in HbA1c from baseline to 24 weeks
详细描述
This trial is a multi-center, open-label, randomized, parallel group trial in patients with T2DM comparing the efficacy and safety of Mylan's insulin glargine with that of Lantus®. Patients with an established diagnosis of T2DM per ADA 2014 criteria and who satisfy the selection criteria will be included in the trial. This will be followed by a 24-week randomized, comparative, parallel-assignment treatment period with Mylan's insulin glargine or Lantus® (in addition to other anti-diabetic drugs). After the treatment period, there will be a follow-up visit; 4 weeks after the patient has been put back on approved medications.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an established diagnosis of T2DM per ADA 2014 criteria who also fulfill the following:
- •Diagnosis established 1 year prior to screening
- •Insulin-naïve OR
- •On Lantus® once daily at stable dose (±15% variation in dose) for at least 3 months prior to screening
- •Body mass index (BMI) of 18.50 to 40.00 kg/m2 at screening (both values inclusive).
- •Stable weight, with no more than 5 kg gain or loss, in the 3 months prior to screening; this information will be collected by patient interview during medical history.
- •Hemoglobin ≥9.0 g/dL at screening
- •Glycosylated hemoglobin (HbA1c) of <10.5% or between 7.5 to 10.5% for insulin naïve patients at screening.
排除标准
- •History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analog preparations used in the trial, OR history of significant allergic drug reactions.
- •History of use of animal insulin within the last 3 years, any insulin other than Lantus® within the last 3 months prior to screening, or use of biosimilar insulin glargine at any time prior to screening.
- •Patients requiring basal-bolus insulin therapy or who in the opinion of the investigator require mealtime insulin in order to achieve glycemic control.
- •Regular use of immune-modulator therapy in the 1 year prior to screening.
- •History of ≥2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness (a sample questionnaire is provided in Appendix I) as judged by the investigator.
- •History of ≥1 episode of hyperglycemic hyperosmolar coma or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.
- •Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg) or hepatitis C (HCVAb) antibodies at screening.
- •History of drug or alcohol dependence or abuse during the 1 year prior to screening.
- •Receipt of another investigational drug in the 3 months prior to screening (or as per local regulations), or if the screening visit is within 5 half-lives of another investigational drug (whichever is longer), or scheduled to receive another investigational drug during the current trial period.
研究组 & 干预措施
Mylan's insulin Glargine
Experimental
receive Mylan's insulin Glargine
干预措施: Mylan's insulin glargine (Drug)
Lantus®
Active Comparator
receive Lantus®
干预措施: Lantus® (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to 24 Weeks
时间窗: 24 weeks
次要结局
- Rate of Hypoglycemic Events Per 30 Days(Baseline and up to 24 weeks)
- Hypoglycemia Occurrence(24 weeks)
- Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time(Week 12 and week 24)
- Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time(week 12 and week 24)
- Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time(week 12 and week 24)
- Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time(Week 12 and week 24)
研究者
研究点 (1)
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