Impacts of Sequential Treatment Using Fixed Dose Pioglitazone/Metformin Combination Following Short-term Intensive Insulin Treatment on Long-term Blood Glucose Control and β-Cell Function in Patients With Newly Diagnosed Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Remission rate
研究概览
简要总结
Short-term intensive insulin therapy (SIIT) induces glycemic remission in patients with newly diagnosed type 2 diabetes. But remission rate reduces over time. This study aims to investigate whether sequential treatments using fixed dose combination of pioglitazone/metformin (15mg/500mg) after SIIT can improve clinical outcomes inpatients with newly diagnosed type 2 diabetes.
We plan to include 50 patients with newly diagnosed type 2 diabetes who are drug naïve and meet the inclusive criteria will be enrolled. After baseline assessments, SIIT will be applied to all patients using insulin pump to achieve and maintain euglycemia for 2 weeks. After completion of intensive treatment, insulin pump will be stopped. Patients were randomly assigned into either of the following two groups: PIO/MET group: pioglitazone/metformin (15mg/500mg) will be orally administrated twice daily to the subjects for 12 weeks; placebo group: placebo is given twice daily to all subjects for 12 weeks. Afterwards, patients will be followed up for 48 weeks. Primary endpoint is difference in remission rate at the end of study. Secondary endpoints include proportion of patients who achieve glycosylated hemoglobin A1C <7% at the end of study; differences in β-cell function , insulin sensitivity and incidence of adverse events among treatment groups.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed type 2 diabetes who have never received any hypoglycemic treatment;
- •Fasting plasma glucose (FPG) between 7.0 mmol/l (126 mg/dl) and 16.7 mmol/l (300 mg/dl); glycosylated hemoglobin A1C>8.5%;
- •Aged between 25 and 65 years,
- •Body mass index (BMI) 22-35 kg/m2.
排除标准
- •Type 1 diabetes or special type of diabetes;
- •Acute diabetic complications of diabetes (DKA, HHS and lactic acidosis etc.)
- •Serious microvascular complications: proliferative stage of retinopathy; urine AER >300 mg/g or urine protein positive, quantification >0.5 g/d; uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy;
- •Severe macrovascular complications: acute cerebrovascular accident, acute coronary syndrome, vascular intervention for peripheral arterial disease or amputation requiring hospitalization within 12 months prior to enrollment;
- •Persistently increased blood pressure >180/110 mmHg;
- •Blood creatinine clearance less than 50 ml/min, alanine aminotransferase ≥2.5×upper limit of normal, total bilirubin ≥1.5×upper limit of normal;
- •Hemoglobin <100 g/L or need regular blood transfusion;
- •Use of drugs that may influence blood glucose within 12 weeks;
- •Systemic infection or serious concomitant disease; patients with malignancy or chronic diarrhea;
- •Uncontrolled endocrine gland dysfunction;
- •Patients with mental or communication disorders;
- •Chronic cardiac insufficiency, heart function class III and above;
- •Pregnant women, lactating women and women of child bearing age who are not willing to take contraception during the study;
- •Subjects who don't cooperate, cannot be followed up or have difficulty in completing the study considered by the investigator.
研究组 & 干预措施
PIO/MET
one fixed dose pioglitazone/metformin (15mg/500mg) tablet will be orally administrated twice daily
干预措施: Pioglitazone + Metformin (Drug)
placebo
one tablet of placebo will be given twice daily
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Remission rate
时间窗: 48 weeks
Remission rate at the end of the study in each group
次要结局
- Insulin sensitivity(48 weeks)
- β-cell function(48 weeks)
- glycemic control(48 weeks)
- Adverse events(48 weeks)
研究者
Yanbing Li
Director of Endocrinology and Metabolism Department
Sun Yat-sen University