Randomized Controlled Study of Dipeptidyl Peptidase-4 (DPP4) Inhibitor (Sitagliptin) Therapy in the Inpatient Management of Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Mean Blood Glucose Levels Among the Three Groups at the Time of Hospitalization to 1st Day After Therapy
研究概览
简要总结
The study is a multicenter, prospective, open-label, randomized pilot study to investigate the safety and efficacy of sitagliptin (Januvia) for the inpatient management of type 2 diabetes (T2D) in general medicine and surgery patients.
详细描述
High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the hospital. Sitagliptin (Januvia®)is effective in lowering blood glucose, but has not been tested in the hospital. It is not known if sitagliptin is as effective in controlling blood sugars in the hospital. This study will compare sitagliptin by mouth, insulin (glargine) injection, and the combination of sitagliptin and lantus insulin in controlling blood sugar in hospitalized patients with diabetes.
In this pilot study, patients with known history of diabetes treated with diet and/or oral anti-diabetics or with low total daily dose insulin therapy (<0.4 unit/kg/day) will be randomized to receive sitagliptin once daily (group 1), sitagliptin plus basal (glargine) insulin once daily (group 2), or basal bolus regimen with glargine once daily and lispro insulin before meals (group 3). If needed, patients in the 3 treatment groups will receive correction doses of rapid-acting lispro (Humalog®) insulin in the presence of hyperglycemia (BG > 140 mg/dl) per sliding scale. The overall hypothesis is that treatment with sitagliptin once daily alone or in combination with basal insulin in patients with type 2 diabetes will result in a similar improvement in glycemic control and in a lower frequency of hypoglycemic events than treatment with basal bolus insulin regimen with glargine once daily and lispro insulin before meals.
A total of 90 subjects with type 2 diabetes will be recruited in this study. Patients will be recruited at Grady Memorial Hospital and Emory University Hospital.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females between the ages of 18 and 80 years admitted to a general medicine and surgery services.
- •A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding Trazodone (TZDs) and DPP4 inhibitors), or low-dose (≤ 0.4 units/kg/day) insulin therapy.
- •Subjects with a BG >140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 milliequivalent /L or positive serum or urinary ketones).
排除标准
- •Age < 18 or > 80 years.
- •Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
- •Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) [46].
- •History of TZD treatment (pioglitazone or rosiglitazone) or DPP4 inhibitor (sitagliptin or saxagliptin) during the past 3 months prior to admission.
- •Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require prolonged admission to a critical care unit (ICU, cardiac care unit , surgical intensive care unit, neuro ICU).
- •Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
- •Medical or surgical patients expected to be kept nil per os (NPO) for >24-48 hours after admission or after completion of surgical procedure.
- •Patients with clinically relevant pancreatic or gallbladder disease.
- •Patients with congestive heart failure (NYHA class III and IV), acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (serum creatinine ≥ 2.0 mg/dL).
- •Treatment with oral or injectable corticosteroid.
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- •Female subjects are pregnant or breast feeding at time of enrollment into the study.
研究组 & 干预措施
Sitagliptin + SSI prn
Sitagliptin once daily plus supplemental doses of lispro if needed using sliding scale insulin (SSI). 100 mg/day (at any time of day) for patients with GFR 50-100 ml/min and 50 mg/day for patients with GFR 30-50 ml/min
干预措施: Sitagliptin (Drug)
Sitagliptin and glargine+ SSI
Sitagliptin 50-100 mg per oral once a day and SubCutaneous (SQ) glargine insulin once daily + correctional doses of lispro if needed for elevated blood glucose using sliding scale insulin (SSI). 100 mg/day (at any time of day) for patients with glomerular filtration rate (GFR) 50-100 ml/min and 50 mg/day for patients with GFR 30-50 ml/min
干预措施: glargine (Drug)
Glargine and Lispro + SSI
Glargine once daily and lispro before meals supplemental insulin lispro as needed for elevated blood glucose using sliding scale insulin (SSI)
干预措施: lispro (Drug)
结局指标
主要结局
Mean Blood Glucose Levels Among the Three Groups at the Time of Hospitalization to 1st Day After Therapy
时间窗: Admission and after 1st day of therapy
The primary outcome of the study is to determine differences in glycemic control as measured by mean BG concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with type 2 diabetes mellitus, at the time of admission to the blood glucose levels 24hrs after the therapy
次要结局
- Number of Patients With Hypoglycemic Events Among the Treatment Groups(during hospitalization,up to 10 days)
- Number of Patients With Severe Hypoglycemic Episodes Among the 3 Treatment Groups(during hospitalization,up to 5 days)
- Number of Patients With a Mean Daily BG > 240 mg/dL After the 1st Day of Treatment Among the Treatment Groups(during hospitalization,up to 10 days)
- Mean Total Daily Dose of Insulin in Units/Day Given During Hospitalization Among the Three Groups(during hospitalization, up to 10 days)
- Mean Length of Stay in Days in the Hospital Among Different Groups(during hospitalization, up to 10 days)
- Number of Subjects With Acute Renal Failure Among the Three Randomized Groups During Hospitalization(during hospitalization, up to 10 days)
- Number of Deaths Among the Subjects in Different Groups(during hospitalization, up to 10 days)
- Percent of Blood Glucose Readings Within Target Range Between 70 and 140 mg/dL Among the Three Groups After 24 Hrs of Randomized Treatment(during hospitalization, up to 10 days)
研究者
Guillermo Umpierrez, MD
Professor of Medicine
Emory University