Linagliptin Inpatient Trial: A Randomized Controlled Trial on the Safety and Efficacy of Linagliptin (Tradjenta®) Therapy for the Inpatient Management of General Surgery Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 5
- 主要终点
- Differences in Glycemic Control
研究概览
简要总结
This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are > 140 mg/dl.
The patients will be monitored for their blood sugars while the hospital.
If patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.
详细描述
Specific Aim 1: To determine whether in-hospital glycemic control, as measured by mean daily glucose concentration and frequency of hypoglycemic events, is different between treatment with linagliptin (Tradjenta®) plus correction doses with a rapid-acting insulin analog before meals and a basal bolus regimen with glargine once daily and rapid-acting insulin analog before meals in general surgery patients with T2D.
Specific Aim 2: To determine the efficacy and safety of an A1C based discharge algorithm in controlling BG after discharge in patients with T2D. Patients who participate in the in-hospital arm (Aim 1) will be invited to enroll in this open label prospective outpatient study. The total duration of the study is 3 months.
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 female surgical non-ICU patients ages between18 and 80 years
- •A known history of T2D > 1 month, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding DPP-4 inhibitors) or low-dose (≤ 0.5 units/kg/day) insulin therapy.
- •Subjects with a BG >140 mg and < 400 mg/dL at time of randomization without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones)
排除标准
- •Age < 18 or > 80 years.
- •Subjects with increased BG concentration, but without a 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) (43).
- •Treatment with dipeptidyl peptidase-4 (DPP4) inhibitor or Glucagon-like peptide-1 (GLP1) analogs during the past 3 months prior to admission.
- •Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require admission to a critical care unit.
- •Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
- •Patients with clinically relevant pancreatic or gallbladder disease.
- •Patients with previous history of pancreatitis
- •Patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (GFR < 30 ml/min).
- •Chronic use of steroid with total daily dose (prednisone equivalent) >5 mg/day
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- •Pregnancy or breast feeding at time of enrollment into the study.
- •Patients who received supplemental sliding scale insulin >72 hours prior to randomization
- •Patients who received basal insulin > 48 hours prior to randomization
研究组 & 干预措施
Linagliptin In-hospital
Linagliptin once daily+ correction doses of aspart or lispro if needed
干预措施: Linagliptin (Drug)
Basal Bolus In-hospital
Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
干预措施: Basal Bolus (Drug)
Linagliptin on discharge
Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.
干预措施: Linagliptin (Drug)
Linagliptin+50%Glargine dose on d/c
Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.
干预措施: Linagliptin + 50% Glargine dose on discharge (Drug)
Linagliptin+80%Glargine dose on d/c
Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.
干预措施: Linagliptin + 80% Glargine (Drug)
结局指标
主要结局
Differences in Glycemic Control
时间窗: Inpatient (average 5 days) and outpatient up to 12 weeks
Determine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group.
次要结局
- Daily Dose of Insulin(Inpatient (average 5 days) and outpatient up to 12 weeks)
- Number of Participants Requiring ICU Care During Hospitalization(During Hospitalization-average 5 days)
- Hospital Mortality(During Hospitalization-average 5 days)
- Hypoglycemia <70 mg/dl(Inpatient (average 5 days) and outpatient up to 12 weeks)
- Hyperglycemia(Inpatient (average 5 days) and outpatient up to 12 weeks)
- Length of Hospital Stay(During Hospitalization)
- Hospital Complications(During Hospitalization-average 5 days)
- Emergency Room Visits(3 months after discharge)
- Acute Renal Failure During Hospitalization(During Hospitalization-average 5 days)
- Fasting BG Concentration(During Hospitalization (average 5 days) and outpatient up to 12 weeks)
- Subjects With Wound and Other Infections(During Hospitalization and outpatient up to 12 weeks)
- HbA1c Level(Admission to the hospital and 12-week follow-up outpatient visit)
- Hypoglycemia < 40 mg/dl(Inpatient and up to 12 weeks outpatient)
- Subjects With Surgical Reinterventions(Inpatient and up to 12 weeks outpatient)
- Outpatient Mortality(3 months after discharge)
研究者
Guillermo Umpierrez, MD
Professor of Medicine
Emory University