The Randomized Multiple Center Trial for The Effectiveness and Safety of Adding Compound Preparation of Pioglitazone and Metformin for Type 2 Diabetic Patients Who Have Bad Glycemic Control With the Initial Treatment of Sulfonylureas
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Change of HbA1c From Baseline at Week 12
研究概览
简要总结
Secondary failure of sulfonylureas (SUs) can occur in about 30%-40% of type 2 diabetic patients after treatment with SUs for 5 years, although SUs are widely used in type 2 diabetic patients. This study was designed to evaluate the effectiveness and safety of adding compound preparation of pioglitazone and metformin for type 2 diabetic patients who have bad glycemic control with the initial treatment of SUs.
详细描述
Design of this clinical trial was multicenter, randomized, double-blind and placebo parallel controlled. Type 2 diabetic patients having bad glycemic control with the initial treatment of SUs were included. They were randomly divided into experiment group and control group, respectively taking compound preparation of pioglitazone and metformin (2mg/500mg) and placebo with identical shape immediately before a meal twice a day. Course of the treatment was 12 weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients (WHO criterion, 1999)
- •19kg/m2 ≤ BMI ≤ 35kg/m2
- •Subject with the initial treatment of SUs on the basis of controlling diet and sport; treatment lasting for no less than 3 months and stable dose for at least 1 month; HbA1c 7-11%
- •No insulin therapy during 6 months before being selected
- •Not involved in any drug test during 3 months before being selected
- •No serious heart, liver or kidney diseases
- •Must have effective contraception methods for women of child-bearing age
- •Willing to being informed consent
排除标准
- •Type 1 diabetes or other specific types of diabetes
- •Pregnancy, preparation for pregnancy, lactation and women of child-bearing age incapable of effective contraception methods
- •Uncooperative subject because of various reasons
- •Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) > twice the upper limits of normal
- •Impairment of renal function, serum creatinine: ≥ 133mmol/L for female，≥ 135mmol/L for male
- •Serious chronic gastrointestinal diseases
- •Serious heart diseases, such as cardiac insufficiency (level III or more according to NYHA), acute coronary syndrome and old myocardial infraction
- •Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg
- •White blood count (WBC) < 4.0×109/L or platelet count (PLT) < 90×109/L，or definite anemia (Hb：< 120g/L for male, < 110g/L for female), or other hematological diseases
- •Endocrine system diseases, such as hyperthyroidism and hypercortisolism
- •Experimental drug allergy or frequent hypoglycemia
- •Psychiatric disorders, drug or other substance abuse
- •Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy
- •Stressful situations such as surgery, serious trauma and so on
- •Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease
- •Combined use of drugs effecting glucose metabolism such as glucocorticoid
- •Tumor, especially bladder tumor and/or family history of bladder tumor and/or long-term hematuria
研究组 & 干预措施
Pioglitazone and Metformin
Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
干预措施: Pioglitazone and Metformin (Drug)
Placebo
Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change of HbA1c From Baseline at Week 12
时间窗: Baseline, Week 12
Measuring venous level of HbA1c at the start of the trail and at week 12 in all subjects, then using the natural logarithm of HbA1c to analyze the change in HbA1c from baseline at week 12 and compare that between experiment group and control group, since the HbA1c wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).
次要结局
- Change of 2-hour Postprandial Insulin From Baseline at Week 12(Baseline, Week 12)
- Change of LDL From Baseline at Week 12(Baseline, Week 12)
- Change of FPG From Baseline at Week 12(Baseline, Week 12)
- Change of 2hPPG From Baseline at Week 12(Baseline, Week 12)
- Change of Fasting Insulin From Baseline at Week 12(Baseline, Week 12)
- Change of TG From Baseline at Week 12(Baseline, Week 12)
- Change of TC From Baseline at Week 12(Baseline, Week 12)
- Change of HDL From Baseline at Week 12(Baseline, Week 12)
研究者
Xuefeng Yu
Director of Department of Endocrinology
Huazhong University of Science and Technology