Basal Insulin Therapy in Patients With Insulin Resistance: A 6 Month Comparison of Insulin Glargine and NPH Insulin
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Difference in A1C between groups at 6 months
研究概览
简要总结
This study will compare the safety, effectiveness, and cost of two different types of long-acting insulin.
详细描述
In this study the investigators will be comparing two long-acting insulins, insulin glargine and NPH insulin. The trial will be evaluating differences in effectiveness, safety and cost between the two agents when used in patients on more than 80 units or 1unit/kg long-acting insulin. The investigators hypothesis is that patients switched from lantus to NPH will have improved blood glucose control.
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
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients at 22 Providence Medical Group primary care clinics
- •Diagnosis of type 2 diabetes mellitus
- •Currently using greater than 80 units/day of insulin glargine or greater than 1 unit/kg/day of insulin glargine
- •Current A1C > 8.5% (within 3 months of randomization)
排除标准
- •Diagnosis of type 1 diabetes mellitus
- •Age > 85 years
- •Self-reported history of severe hypoglycemia or hypoglycemia unawareness
- •Hospice/limited life expectancy
- •Current enrollment in Providence Medical Group Medication Assistance Program
- •Current use of a GLP1 agonist (i.e., liraglutide, exenatide, exenatide extended-release)
- •End stage renal disease (i.e., dialysis or estimated glomerular filtration rate <15 ml/min/1.73m2)
- •Cirrhosis
- •Unstable coronary artery disease or chronic heart failure (i.e. an exacerbation or hospitalization within 6 months pre-randomization)
- •Psychiatric condition that prevents adequate follow-up (i.e., > 3 missed follow-up visits within a 3 month period or persistent non-adherence to dosing or monitoring recommendations)
- •Active alcohol or drug abuse
- •Inability to provide informed consent
研究组 & 干预措施
Switching to NPH insulin
Patients in this arm will be transitioned from insulin glargine to NPH insulin with subsequent titration according to algorithm within protocol. If needed, meal-time insulin will be added during study period.
干预措施: Switching to NPH insulin (Drug)
Continuation of insulin glargine
Patients in this arm will continue on insulin glargine and serve as a control group.
干预措施: Continuation of insulin glargine (Drug)
结局指标
主要结局
Difference in A1C between groups at 6 months
时间窗: 6 months
次要结局
- Difference in A1C between groups at 3 months(3 months)
- Difference in incidence of hypoglycemia between each group(6 months)
- Difference in self-monitored blood glucose averages between groups(6 months)
- Difference in percent of patients who require initiation/titration of prandial insulin between each group(6 months)
- Difference in rate of mortality in each group during study period(6 months)
- Difference in units of basal insulin used per day between groups(6 months)
- Difference in total units of insulin per day between groups(6 months)
- Differences in change in weight during study period between groups(6 months)
- Difference in number of visits with clinical pharmacist(6 months)
- Difference in morbidity between each group during study period(6 months)
- Compare cost of insulin therapy over study period at study completion(6 months)