A Randomized Controlled Trial Comparing the Safety and Efficacy of Liraglutide Versus Glargine Insulin for the Management of Patients With Type 2 Diabetes After Hospital Discharge
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 5
- 主要终点
- Glycemic Control at Hospital Discharge and 6 Months Follow up
研究概览
简要总结
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. Increasing evidence indicates that incretin-based agents are safe and effective for the hospital management of patients with type 2 diabetes (T2D).
Liraglutide is a once-daily human glucagon-like peptide (GLP-1) analogue approved for the treatment of T2D. Liraglutide has been shown to lower blood glucose, stimulate endogenous insulin secretion, decrease plasma glucagon levels, inhibit gastric emptying, reduce food intake and body weight and improve ß-cell function when administered subcutaneously. Liraglutide increases insulin secretion in a glucose-dependent manner (i.e., only when plasma glucose levels are elevated), resulting in low-risk of hypoglycemia when used as monotherapy. When compared to insulin glargine therapy, the use of GLP-1 has resulted in comparable reduction in HbA1c level, lower rates of hypoglycemia and less weight gain. No prospective studies; however, have compared the efficacy and safety of liraglutide in the hospital setting or after hospital discharge.
The primary objective is to compare the safety and efficacy of liraglutide (Victoza®) versus glargine insulin in combination to oral anti-diabetic agents (OADs: metformin, sulfonylureas, nateglinide, repaglinide or pioglitazone) on glycemic control after 26 weeks of treatment in medicine patients with T2D after hospital discharge.
详细描述
Specific Aim: To determine whether treatment with liraglutide (Victoza®) will result in similar glycemic control (HbA1c at 26 weeks) and a lower rate of hypoglycemic events compared to treatment with glargine (Lantus®) in patients with T2D after hospital discharge. Patients with poorly controlled (HbA1c >7%-10%) T2D treated with diet or oral antidiabetic agents or low dose insulin naïve (0.4u/kg/day) prior to admission will be randomized to liraglutide or glargine in combination to OADs at hospital discharge.
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 discharged after hospital admission from non- ICU general surgery and medicine services (excluding gastrointestinal and cardiac surgeries).
- •Admission HbA1c between 7% and 10%
- •Patients with T2D treated with diet alone or with oral antidiabetic agents as monotherapy or in combination therapy (excluding GLP1 receptor agonists) or on low-dose insulin therapy (TDD ≤0.4 unit/kg/day) prior to admission.
- •Subjects with a hospital admission BG < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).
- •BMI > 25 Kg/m2 and ≤ 45 Kg/m2
排除标准
- •Age < 18 or > 80 years.
- •Subjects with stress hyperglycemia (BG > 140 mg/dL and HbA1c < 6.5%)
- •Subjects with a history of type 1 diabetes
- •Treatment with insulin or GLP-1 analogs during the past 3 months prior to admission.
- •Recurrent severe hypoglycemia or hypoglycemic unawareness.
- •Subjects with gastrointestinal obstruction, gastroparesis, or those expected to require gastrointestinal suction.
- •History of medullary thyroid cancer or multiple endocrine neoplasias
- •Patients with acute or chronic pancreatitis, pancreatic cancer, or gallbladder disease.
- •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 < 30 ml/min).
- •Treatment with oral or injectable corticosteroid (equivalent or higher than prednisone 5mg/day), parenteral nutrition, and immunosuppressive treatment.
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- •Female subjects who are pregnant or breastfeeding at the time of enrollment into the study.
- •Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice).
研究组 & 干预措施
Liraglutide + OADs
Liraglutide once daily in combination to oral anti-diabetic agents (OADs)
干预措施: Liraglutide + OADs (Drug)
Glargine + OADs
Glargine once daily in combination to oral anti-diabetic agents (OADs)
干预措施: Glargine + OADs (Drug)
结局指标
主要结局
Glycemic Control at Hospital Discharge and 6 Months Follow up
时间窗: Hospital discharge, 6 months (26 weeks)
To determine differences in HbA1c concentration at 26 weeks from discharge between liraglutide and glargine insulin therapy
次要结局
- Acute Renal Failure(After discharge, average 6 months)
- Cardiovascular Risk Factor: Lipid Profile(26 weeks post-intervention)
- Emergency Room Visits and Readmissions(After discharge, average 6 months)
- Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks(After discharge, average at 3 months (12 week) and 6 months (26 weeks))
- Hypoglycemic Episodes(After discharge, average 6 months)
- HbA1c <7.0% and no Weight Gain(After discharge, average 6 months)
- Change in Cardiovascular Risk Factors: Blood Pressure(Baseline, 26 weeks post-intervention)
- HbA1c <7.0% and no Hypoglycemia(After discharge, average 12 weeks)
- Change in Body Weight From Baseline(After discharge, average 6 months)
- Change in BMI(Baseline, and follow up after discharge (average 6 months))
- Total Daily Dose of Insulin(After discharge, average 6 months)
- Cardiovascular Risk Factor: Heart Rate(26 weeks post-intervention)
- Self-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up(26 weeks post-intervention)
研究者
Guillermo Umpierrez, MD
Professor of Medicine
Emory University