Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Switching Premix Human Insulin to Aspart30 in T2DM With Inadequate Glycaemic Control on Premixed Human Insulin and Metformin: a Randomized, Open, Parallel Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 349
- 试验地点
- 1
- 主要终点
- the absolute change in HbA1c from baseline to 24-week endpoint of basal insulin glargine combination with exenatide bid vs. switching to aspart30 in type 2 diabetic patients inadequately controlled on premixed human insulin and metformin.
研究概览
简要总结
Efficacy and Safety of Basal Insulin Glargine Combination with Exenatide bid vs Switching Premix Human Insulin to Aspart30 in T2DM with Inadequate Glycaemic Control on Premixed Human Insulin and Metformin: a Randomized, Open, Parallel trial.
详细描述
This is a multicentre, open-label, randomized and parallel trial that will compare the efficacy and safety of basal insulin glargine combination with Exenatide bid vs. switching premix human insulin to aspart30 in type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin. Approximately 248 patients will be enrolled in the study from China and randomized in a 1:1 ratio to one of the 2 treatment arms: once-daily insulin glargine + twice-daily exenatide + metformin; or twice-daily aspart 30 + metformin.
Study treatment will continue for 24 weeks. The primary efficacy measure is the change in HbA1c at 24 weeks. The study consists of 3 periods: a 1-week screening (period A), a 12-week run-in period (period B) and a 24-week treatment period (period C).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Type 2 diabetic patients receiving twice-daily premixed human insulin 30 therapy ≥ 30 U/d and metformin with maximum tolerated dosage (≤ 1500mg/d)
- •HbA1c > 8.0 % and < 11.0 % (HbA1c > 7.0 % and < 10.0% at randomization)
- •Men and women (non-pregnant and using a medically approved birth-control method) aged ≥ 18 and ≤ 70 years
- •BMI ≥ 23 and ≤ 35 kg/m2
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
glargine + exenatide
Type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin previously. After a 12-week run-in period , switching premix human insulin to glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily).
干预措施: glargine + exenatide (Drug)
aspart 30
Type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin previously. After a 12-week run-in period , switching premix human insulin to aspart 30 ( subcutaneous injection, twice daily).
干预措施: aspart 30 (Drug)
结局指标
主要结局
the absolute change in HbA1c from baseline to 24-week endpoint of basal insulin glargine combination with exenatide bid vs. switching to aspart30 in type 2 diabetic patients inadequately controlled on premixed human insulin and metformin.
时间窗: from baseline to 24-week endpoint
次要结局
- Fasting blood glucose(12 weeks and 24 weeks)
- Change in HbA1c from baseline to 12 weeks endpoint(from baseline to 12 weeks endpoint)
- The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%(12 weeks and 24 weeks)
- Daily insulin use(baseline, 12 weeks and 24 weeks)
- Change in body weight(from baseline to 12 and 24 weeks)
- The incidence and rate of hypoglycaemic events during the study(baseline, 12 weeks and 24 weeks)
研究者
Xuefeng Yu
Director of Department of Endocrinology
Huazhong University of Science and Technology