Efficacy and Durability of Glucagon Like Peptide 1 Receptor Agonists (GLP-1 RA)/Thiazolidinedione Versus Basal Bolus Insulin Therapy in Poorly Controlled Type 2 Diabetic Patients (T2DM) Patients on Sulfonylurea Plus Metformin
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
To compare efficacy, safety and durability of combination therapy with pioglitazone plus GLP-1 RA versus basal bolus insulin in poorly controlled T2DM patients on metformin plus sulfonylurea
详细描述
poorly controlled (HbA1c >7.5%) T2DM patients (18-75 years of age) on maximal/near maximal dose of sulfonylurea plus metformin who otherwise are healthy will be randomized to receive:
- exenatide weekly injection (2 mg/week)
- glargine insulin plus insulin aspart which will be titrated to maintain HbA1c <7.0%
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
- •T2DM poorly controlled (HbA1c >7.5%) on metformin (>1700 mg/day) plus sulfonylurea
排除标准
- •type 1 diabetes (T1DM) patients receiving therapy with pioglitazone, GLP-1 RA and insulin abnormal kidney, liver or heart function patients with malignancy
研究组 & 干预措施
Combination Therapy
pioglitazone (actos) 30 mg per day and exenatide (bydureon) 2 mg per week
干预措施: Pioglitazone plus exenatide (Drug)
Insulin Therapy
insulin glargine (lantus) will be started every morning and the dose will be weekly increase to achieve fasting plasma glucose (FPG) <110 mg/dl.
and Aspart insulin will be started before meals and the dose is adjusted to maintain HbA1c <7.0% and postprandial plasma glucose (PPG) <140 mg/dl
干预措施: insulin glargine and insulin aspart (Drug)
结局指标
主要结局
HbA1c
时间窗: 3 years
difference in HbA1c between the two treatment groups will be compared at 1 and at 3 years to determine efficacy and durability of each treatment
次要结局
- percentage of patients who achieve HbA1c <7.0% and <6.5% at 1 year and at 3 years(3 years)
- hypoglycemia rate(3 years)
- change in the FPG(3 years)
- change in body weight(3 years)
研究者
Dr. Muhammad Abdulghani
Professor of Medicine
Hamad Medical Corporation