The Effect of Glimepiride Compared With Sitagliptin as an add-on Therapy to Metformin in Severe Insulin Deficiency Diabetes
试验速览
- 阶段
- 4 期
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Reduction of hemoglobin A1c from baseline at the end of the trial.
研究概览
简要总结
The purpose of the trial is to verify the effectiveness and safety of glimepiride compared with sitagliptin as an add-on therapy to metformin in severe insulin deficiency diabetes.
详细描述
This clinical trial is a multi-centre, prospective, intervention, randomized-controlled clinical trial, and uses a superiority test to determine whether the experimental group is superior to the control group in terms of main efficacy endpoints.
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
- •According to the World Health Organization (the WHO) 1999 criteria for the diagnosis of type 2 diabetes; the subtype was allocated to severe insulin deficiency diabetes (SIDD) at diagnosis using data-driven diabetes clusters APP.
- •Men and women aged ≥ 18 years and ≤ 75 years;
- •Diagnosed as severe insulin deficiency diabetes by the cluster classifier of Peking University People's Hospital at the initial stage of the disease course;
- •Metformin monotherapy with dosage ≥1500 mg/day for at least 8 weeks;
- •Diabetes duration less than 5 years;
- •The HbA1c value of the central laboratory before randomization: 7.0% ≤ HbA1c <10.5%
- •estimated estimated glomerular filtration rate (eGFR)>=60 ml/min1.73m2, alanine aminotransferase(ALT)<120U/L ;
- •If other drugs are used during the course of the disease, these drugs should be withdrawn for more than 8 weeks;
- •Without acute diabetic complications at present.
排除标准
- •Type 1 diabetes or other special types of diabetes mellitus; glutamic acid decarboxylase antibody (GADA) positive, the subtype was allocated to other subtypes at diagnosis using data-driven diabetes clusters APP.
- •Pregnancy or have a pregnancy plan within a year;
- •Lactation or have a lactation plan within a year;
- •Renal insufficiency, eGFR<60; transaminase elevated, ALT>= 120U/L; unstable coronary heart disease.
- •Recurrent spontaneous diabetic ketosis or uncorrected acute diabetic complications;
- •Participated in other clinical trials within 8 weeks before randomization; Unable to complete the study follow-up for 6 months; Have situations such as operation and need to change to insulin therapy in 6 months.
- •Use concomitant medication such as glucocorticoids which can affect blood sugar.
- •The investigator judged that it is not suitable to participate in this clinical trial.
研究组 & 干预措施
Glimepiride
All participants have background therapy of metformin 1500mg-2000mg, glimepiride1-4mg were added in the patients randomised to this arm considering the baseline HbA1c of the participants.
干预措施: Glimepiride (Drug)
Sitagliptin
All participants have background therapy of metformin 1500mg-2000mg, Sitagliptin 100mg were added in the patients randomised to this arm regardless of the baseline HbA1c level in this arm.
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Reduction of hemoglobin A1c from baseline at the end of the trial.
时间窗: 26 weeks
The Least squre mean of the decline of hemoglobin A1c from baseline to the end of the trial
次要结局
- Hemoglobin A1c on-target rate(26 weeks)
- The difference of self measure blood glucose (SMBG) at every month(for 26 weeks)
- The incidence rate of hypoglycemia(for 26 weeks)
- The level of weight gain(for 26 weeks)
研究者
Xiantong Zou, MD. Ph.D.
Attending Physician of the Department of Endocrinology and Metabolism
Peking University People's Hospital