A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient and Post-Hospital Discharge Management of Medicine and Surgery Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 4
- 主要终点
- Mean Daily Blood Glucose Concentration Inpatient
研究概览
简要总结
The purpose of this study is to find out if treatment with Glargine U300 when compared to Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D), who are admitted to the hospital and then transition at home, after discharge from the hospital.
详细描述
Several randomized clinical trials done previously in medicine and surgical patients with T2D have shown that basal bolus regimen with glargine results in a lower mean daily blood glucose (BG) concentrations compared to the sole use of sliding scale regular insulin (SSI) and in lower rate of hospital complications. Glargine U300 results in similar improvement but in lower rate of hypoglycemia than treatment with glargine U100. No previous studies; however, have compared the efficacy and safety of glargine U300 in the management of hyperglycemia and diabetes in the hospital setting. This study will determine if treatment with glargine U300 has a similar glucose control in patients with diabetes admitted to the hospital and if glargine U300 will result in lower number of low blood sugars compared to glargine U100 .
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females between > 18 years admitted to a general medicine or surgical service.
- •Known histories of T2D treated with either diet alone, oral monotherapy, any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy with the exception of degludec and glargine U
- •Subjects must have an admission/randomization BG > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary ketones).
排除标准
- •Subjects with increased BG concentration, but without a known history of diabetes.
- •Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA (weekly exenatide, dulaglutide or albiglutide).
- •Patients with acute critical or surgical illness admitted to the ICU or expected to require admission to the ICU.
- •Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (eGFR< 30 ml/min).
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- •Female subjects who are pregnant or breast feeding at time of enrollment into the study.
研究组 & 干预措施
Basal bolus insulin with glargine U300 and glulisine insulin
Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.
干预措施: Glargine U300 (Drug)
Basal bolus insulin with glargine U300 and glulisine insulin
Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.
干预措施: Glulisine Insulin (Drug)
Basal bolus insulin with glargine U100 and glulisine insulin
Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.
干预措施: Glargine U100 (Drug)
Basal bolus insulin with glargine U100 and glulisine insulin
Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.
干预措施: Glulisine Insulin (Drug)
结局指标
主要结局
Mean Daily Blood Glucose Concentration Inpatient
时间窗: up to 10 days (day of hospital discharge)
The mean daily blood glucose concentration for all participants will be calculated by taking the average of all pre-meal and bedtime glucose values collected each day after the first day of therapy during the hospital stay.
Mean Daily Blood Glucose Concentration After Hospital Discharge
时间窗: assessed from day 11 (day after hospital discharge) up to 3 months
Subjects will measure their blood sugar levels at home by finger stick before meals two or three times per day and record the readings in a diary. The readings will be averaged for each day and the mean daily blood glucose concentration will be calculated.
次要结局
- Percent of Subjects With Hypoglycemic Events(3 months post enrollment)
- Hospital Mortality(During hospital stay - up to 10 days)
- Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8%(up to 3 months post enrollment)
- Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days(Up to 5 days)
- Percent of Blood Glucose 70-180 Measured by Point of Care Test(3 months post enrollment)
- Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days(Up to 10 days)
- Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8%(up to 3 months post enrollment)
- Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days(Up to 3 days)
- Percent of Subjects With Severe Hypoglycemia(3 months post enrollment)
- Number of Days of Hospital Stay(Up to 10 days)
- Number Subjects With Cardiac Complications(3 months post enrollment)
- Number of Patients With Acute Renal Failure(3 months post enrollment)
研究者
Guillermo Umpierrez, MD
Professor
Emory University