Treatment of Early Insulinization With Glargine in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea or Metformin Monotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 387
- 试验地点
- 1
- 主要终点
- A1c values
研究概览
简要总结
Primary:
- To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline to endpoint A1c < 7%)
Secondary:
- To investigate the safety of insulin glargine (in terms of hypoglycaemia, including symptomatic, non-symptomatic and nocturnal hypoglycaemia)
- To investigate whether beta cell function is preserved if this therapy is initiated before 2nd OAD (oral anti-diabetic drug) failure
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes patients with first OAD (Sulfonylurea [SU] or Metformin) failure
- •Patients who are insulin naive (unless it was used for gestational diabetes or if insulin therapy was less than 1 week)
- •Serum creatinine ≤ 1.5mg/dL
- •BMI: 21-41 kg/m²
- •7.5%< A1c <11%
- •Fasting plasma glucose > 7.5mmol/L
- •On diet and exercise therapy and stable OAD treatment (SU or metformin > ½ maximal dose)for more than 1 month prior to enrolment
- •Women not of childbearing potential (sterilization procedure done or menopausal > 2 years), or if of childbearing potential, agree to take reliable contraceptive measures during the study
- •Able and willing to monitor blood glucose
- •Able and willing to perform 7 point blood glucose self monitoring at baseline, 12 week and 24 week
- •Understand that there is a 50% chance of being randomized to the insulin treatment arm and is willing to self inject insulin
排除标准
- •Type 1 diabetes
- •Acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma
- •Pregnancy, breast-feeding
- •People who work night shifts
- •Hypersensitivity to investigational drugs or its additives, or intolerability to metformin
- •Need for use of medications prohibited by the protocol during the study for treatment purpose
- •Significant diseases in cardiovascular, liver, nerve, endocrine or other systems, unable to complete the study or difficult to be used in study analysis
- •Drugs or alcohol abuse
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Administration of Insulin Glargine and Sulfonylurea or Metformin
干预措施: Insulin Glargine (Drug)
1
Administration of Insulin Glargine and Sulfonylurea or Metformin
干预措施: Metformin (Drug)
2
Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
干预措施: Glyburide (Drug)
2
Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
干预措施: Glyclazide (Drug)
2
Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
干预措施: Glimiperide (Drug)
2
Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
干预措施: Glipizide (Drug)
2
Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
干预措施: Metformin (Drug)
结局指标
主要结局
A1c values
时间窗: At baseline and 24 weeks
次要结局
- Adverse events including hypoglycemia(From the beginning to the end of the study)