Safety and Efficacy of Linagliptin Therapy in the Setting of Internal Medicine Department Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 主要终点
- Percentage of patient with mean blood glucose levels
研究概览
简要总结
Prospective, open labels, randomized study. A total of 60 admitted patient between 18 and 85 years old with known with history of DM for more than 3 months and an average of two consecutive blood glucose levels above 180 mg/dl (after stopping all previous oral antidiabetic and insulin on admission) will be enrolled Patient will be randomized to a 1:1 ratio in two treatment groups regimens- linagliptin (trajenta) once daily combined with basal insulin at bed time (glargine Lantus; sanofi) and basal bolus insulin with glargine once daily and glulisine (Apidra; sanifi) before meals.
Patient will be discharged according to discharged protocol. Follow-up visits will take place at 3 and 6 months post discharged.
详细描述
patient in the linagliptin plus basal insulin will receive linagliptin at single dose of 5 mg/day, and a starting total daily dose (TDD) of glargine of 0.3 units/kg/day, while patients >70 years of age and/or with a serum creatinine >2.0 mg/dL will receive starting TDD of 0.15 units/kg.
Patient in the basal bolus group will start at a TDD of 0.5 units/kg divided half as insulin glargine once daily and half as insulin glulisine before meals. In patients >70 years of age and/or with a serum creatinine >2.0 mg/dL, the starting TDD will be reduce to 0.3 units/kg.
The results of BG values will be measured as 2 hour pre meal glucose, bedtime glucose, and mean daily BG after first day at hospital, HbA1c will be measured on the first day of hospitalization.
Patient with pre-meal and bed time blood glucose levels over 180 mg/dl will receive correctional doses of short acting insulin based on glucose levels as follow- 180-250mg/dl 2 units of insulin, 250-300 mg/dl 3 units of insulin, 350-400 4 units of insulin.
Hypoglycemic events shall be documented as well. In case of treatment failure, defined as average blood glucose levels or two consecutive measurements of more than 240 mg/dl, patient's treatment will be changed to basal based regimen.Patient with pre-meal and bed time blood glucose levels over 180 mg/dl will receive correctional doses of short acting insulin based on glucose levels as follow- 180-250mg/dl 2 units of insulin, 250-300 mg/dl 3 units of insulin, 350-400 4 units of insulin.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male & female patient with Known history of DM for more than 3 months before randomization.
- •Hospital admission due to blood glucose levels ranging between 180-400 mg/dl.
- •Average of two consecutive blood glucose levels above 180 mg/dl.
- •Age between 18 and 85 years old.
- •Home treatment with diet alone, any combination of oral antidiabetic agents, or insulin therapy at daily dose <0.4 units/kg.
排除标准
- •BG >400 mg/dl in the period before randomization.
- •Prior history of hyperglycemic crises.
- •Have hyperglycemia without history of diabetes.
- •Patient who expected ICU admission or cardiac surgery.
- •A history of pancreatitis, active gallbladder disease, Corticosteroid therapy or hepatic disease.
- •Impaired renal function (glomerular filtration rate [GFR] <30 mL/min or serum creatinine ≥3.0 mg/dL).
- •History of diabetic ketoacidosis.
- •Pregnancy.
- •Inability to give informed consent (poor mental status).
研究组 & 干预措施
Linagliptin and Basal Insulin
linagliptin (trajenta) 5mg once daily combined with basal insulin (glargine Lantus; sanofi) 0.15-0.3 units/kg TDD before bed time.
干预措施: Linagliptin and Basal Insulin (Drug)
Basal Insulin and Bolus Insulin
Basal Insulin (Glargine Lantus; Sanofi) based therapy once daily before bedtime and glulisine (Apidra; sanofi) before meals. insulin dose will be 0.5 units/kg divided half as insulin glargine once daily and half as insulin glulisine before meals.
干预措施: Basal Insulin and Bolus Insulin (Drug)
结局指标
主要结局
Percentage of patient with mean blood glucose levels
时间窗: After firts day from admission and Up to 14 days, 3 and 6 month after discharge.
between 80-180 mg/dl.
次要结局
- Difference in BG values within range(After firts day from admission and Up to 14 days, 3 and 6 month after discharge)
- Number of hypoglycemic events (BG <70 and or < 40 mg/dL).(After firts day from admission and Up to 14 days, 3 and 6 month after discharge)
- Number of episodes of hyperglycemia(After firts day from admission and Up to 14 days, 3 and 6 month after discharge)
- TTD (total daily dose) of insulin(After firts day from admission and Up to 14 days, 3 and 6 month after discharge)
研究者
Dror Dicker
Head of internal medicine D' and obesity clinic
Rabin Medical Center