Liraglutide and Insulin-001 A Randomized Prospective Trial of Liraglutide Added to High-Dose Insulin Therapy vs. High-Dose Insulin Therapy Alone in Insulin-Resistant Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c at six months
研究概览
简要总结
The purpose of this study is to determine the effect of adding liraglutide to high dose insulin therapy compared to high dose insulin therapy alone in patients with insulin-treated Type 2 diabetes with insulin requirements of > 100 units of insulin per day.
详细描述
40 subjects with Type 2 diabetes using > 100 units of insulin per day with or without metformin with HbA1c > 6.5% will be randomized into 2 treatment groups: treatment group will have liraglutide added to insulin and control group will have insulin uptitration only for 6 months. Primary endpoint to be compared between groups will be HbA1c at 6 months. Secondary endpoints will include weight, total daily insulin dose, percent time in euglycemic, hyperglycemic, and hypoglycemic ranges by continuous glucose monitor (CGM), and effect on GlycoMark and hs-CRP. Safety endpoints will include incidence of hypoglycemia and incidence of gastrointestinal side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with Type 2 diabetes with HbA1c from 6.5 to 10% treated with intensive insulin therapy (MDI or CSII, including U-500 insulin-treated patients) using > 100 units of insulin, with or without a stable dose of oral insulin sensitizing medications, for at least three months.
- •Aged 18 to 80 years.
- •Females of child-bearing potential must be using adequate form of contraception.
- •Patient willing to monitor BG four times daily, use CGM, and comply with study-related protocol.
排除标准
- •Type 1 diabetes.
- •Use of any GLP-1 receptor agonist within previous three months.
- •Use of DPP-4 inhibitors or oral insulin secretagogues within the previous three months.
- •Use of glucocorticoids (except inhaled).
- •Use of any experimental drug within previous three months.
- •Known or suspected allergy to liraglutide, Novolog or Levemir.
- •Personal or family history of medullary carcinoma of the thyroid or MEN-
- •Concomitant chronic renal disease with creatinine > 1.5%.
- •Concomitant chronic hepatic, gastrointestinal or other illness (including pancreatitis or active cardiovascular disease except stable exertional angina).
- •Inability or unwillingness to monitor BG, use CGM, or comply with study protocol.
- •Women of child-bearing potential unwilling to use adequate contraception, intending to become pregnant or breast-feeding.
研究组 & 干预措施
liraglutide plus insulin
Patients were randomized to receive liraglutide plus insulin (LIRA) for 12 months.
干预措施: Liraglutide (Drug)
liraglutide plus insulin
Patients were randomized to receive liraglutide plus insulin (LIRA) for 12 months.
干预措施: Insulin (Drug)
Insulin titration only
Patients were randomized to receive insulin only (control) for 6 months. The controls were then crossed over to receive liraglutide plus insulin for 6 months after the initial control period.
干预措施: Insulin (Drug)
结局指标
主要结局
Change from baseline in HbA1c at six months
时间窗: baseline and six months
Glycemic control as measured by HbA1c
次要结局
- GlycoMark(baseline, 3, 6, 9, and 12 months)
- Weight(baseline, 3, 6, 9, and 12 months)
- Total Daily Insulin Dose (TDID)(3, 6, 9, and 12 months)
- Hypoglycemia(6 months and 12 months)