A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Long-Term Care Residents With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Mean Fasting Blood Glucose Level
研究概览
简要总结
This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (HbA1c >7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D. We will also determine differences in clinical outcome, resource utilization, and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin. We will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.
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 with known history of type 2 diabetes, treated with diet, OADs as monotherapy or in combination therapy (excluding DPP4 inhibitors), or sliding scale insulin.
- •Subjects with HbA1c > 7.5% and/or any blood glucose greater than or equal to 180 mg/dL
排除标准
- •Subjects with a history of type 1 diabetes or with a history of diabetic ketoacidosis
- •Treatment with insulin or GLP1 analogs during the past 3 months prior to admission.
- •Recurrent severe hypoglycemia or hypoglycemic unawareness.
- •Subjects with history of gastrointestinal obstruction or gastroparesis.
- •Patients with acute or chronic pancreatitis or pancreatic cancer.
- •Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated ALT and AST > 3 times upper limit of normal, or significantly impaired renal function (GFR < 45 ml/min).
- •Treatment with corticosteroids, parenteral nutrition and immunosuppressive treatment.
- •Mental condition rendering the subject unable to understand the nature and scope of the study.
研究组 & 干预措施
Insulin glargine
Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.
干预措施: insulin glargine (Drug)
linagliptin
Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.
干预措施: linagliptin (Drug)
结局指标
主要结局
Mean Fasting Blood Glucose Level
时间窗: 6 months
The primary endpoint of the study is differences between treatment groups in mean fasting blood glucose level in LTC residents with poorly controlled diabetes.
次要结局
- Number of Hypoglycemic Events < 40mg/dl(over 6 months)
- Total Daily Dose of Insulin(over 6 months)
- HbA1c(6 months)
- Number of Hypoglycemic Events < 70mg/dl(over 6 months)
- Changes in Cognitive Function(over 6 months)
- Number of Participants With Acute Complications(over 6 months)
- Total Number of Emergency Room Visits(6 months)
- Total Number of Hospital Visits(6 months)
- Total Number of Complications(6 months)
- Incidence of Acute Kidney Injury(over 6 months)
- Mortality(over 6 months)
研究者
Guillermo Umpierrez, MD
Professor of Medicine
Emory University