Insulin Glargine Combined With Sulfonylurea Versus Metformin in Patients With Type 2 Diabetes: A Randomized, Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- HbA1c values
研究概览
简要总结
Primary objective:
To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level
Secondary objective:
To compare the incidence of hypoglycemia in each treatment group
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes for at least 6 months
- •Treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea (glimepiride≥ 4 mg/day or equivalent dose of other SU) for at least 3 months prior to the screening visit
- •7.0 < HbA1c < 11 %
- •Fasting serum C-peptide > 0.33 nmol/L
- •BMI < 30 kg/m²
- •Patients who is willing to monitor BG using SMBG
排除标准
- •Type 1 Diabetes
- •Clinical evidence of active liver disease, or serum ALT 3 times the upper limit of the normal range
- •Serum creatinine: ≥ 1.5 mg/dl for males, ≥ 1.4 mg/dl for females
- •Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
- •History of alcohol or other substance abuse
- •Pregnancy or not using contraceptive in childbearing aged women
- •Breast feeding women
- •History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
- •Treatment with any medication including corticosteroid or herbal medicines that can affect blood glucose level within 3 months prior to study entry except metformin and sulfonylurea.
- •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
3
Administration of a combination of 4mg Glimepiride plus 1000mg Metformin with Insulin Glargine
干预措施: Metformin (Drug)
1
Administration of 4 mg of Glimepiride with Insulin Glargine
干预措施: Glimepiride (Drug)
1
Administration of 4 mg of Glimepiride with Insulin Glargine
干预措施: Insulin Glargine (Drug)
2
Administration of 1500 mg of Metformin with Insulin Glargine
干预措施: Metformin (Drug)
2
Administration of 1500 mg of Metformin with Insulin Glargine
干预措施: Insulin Glargine (Drug)
3
Administration of a combination of 4mg Glimepiride plus 1000mg Metformin with Insulin Glargine
干预措施: Glimepiride (Drug)
3
Administration of a combination of 4mg Glimepiride plus 1000mg Metformin with Insulin Glargine
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
HbA1c values
时间窗: At baseline to end of treatment
次要结局
- Hypoglycemia events(From inclusion to end of study)
- Percentage of patients with HbA1c < 7%(At the end of the study)
- Fasting Blood Glucose level(At the end of the study)