Remission Rate of Newly Diagnosed Type 2 Diabetes Outpatients Treated With Short-term Intensive Insulin Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 3
- 主要终点
- prolonged-remission rate
研究概览
简要总结
To evaluate the long-term remission rate of short-term intensive insulin (STII) therapy in newly diagnosed type 2 diabetes outpatients and investigate the predictors contributing to the remission rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, insulin-naive type 2 diabetes outpatients
- •Diabetes duration less than 1 year
排除标准
- •Various acute complications
- •Hepatic transaminase >2.5x normal reference value (glutamic-pyruvic transminase>100U/L, glutamic-oxalacetic transaminase > 100U/L)
- •Abnormal renal functions (serum cretinine>the normal reference value)
- •Cardiac insufficiency (America NYHA caediac function >3)
- •Type 1 diabetes mellitus
- •Ongoing hormone therapy
- •Women in gestation and lactation
- •Patients with other endocrine disorders
研究组 & 干预措施
Novolin 30R;Pioglitazone;Metformin
Drugs: Insulin (Novolin 30R) monotherapy or combined with one or two oral drugs (metformin 0.5 mg tid and pioglitazone hydrochloride 15 mg qd).
干预措施: Novolin 30R;Pioglitazone;Metformin (Drug)
结局指标
主要结局
prolonged-remission rate
时间窗: 5 years
hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of 5 years' duration.
partial-remission rate
时间窗: 5 years
hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of more than 3 months' duration, and less than 5 years.
次要结局
未报告次要终点
研究者
Lin Liao
chief of endocrinology department at Qianfoshan Hospital
Qianfoshan Hospital