Combination of Sulfonylureas and Insulin Glargine as Safety Net Outpatient Therapy for Unstable Diabetes and Impending Diabetic Ketoacidosis (DKA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary outcome was the patients' ability to avoid repeat ED visits or hospitalization in either of the discharge regimens.
研究概览
简要总结
The purpose of this study is to compare two simple and safe emergency department discharge therapy for Type 2 Diabetes patients with severe hyperglycemia and with no indications for inpatient admission.
详细描述
This study is an open label randomized controlled trial in adult DM2 patients seen in ED services at John H. Stroger Hospital of Cook County serving a largely uninsured/underserved population. Individuals more than 18 years of age with DM2, either with new onset DM2 or known diabetics who did not take oral hypoglycemic agents for more than 2 weeks, presenting with fasting blood glucose (FBG) 300-500 mg/dl or random blood glucose (RBG) 400-700 mg/dl and who did not have any exclusion criteria listed in Table 1, were eligible for the study. Subjects were randomized to one of the two fixed dose treatment groups: 1) Glipizide XL 10 mg orally daily prior to breakfast (G group), 2) Glipizide XL 10 mg orally daily along with Insulin Glargine 10 units at bedtime, subcutaneously (G+G group).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals more than 18 years of age with DM2, either with new onset DM2 or known diabetics who did not take oral hypoglycemic agents for more than 2 weeks, presenting with fasting blood glucose (FBG) 300-500 mg/dl or random blood glucose (RBG) 400-700 mg/dl and who did not have any exclusion criteria listed in Table 1, were eligible for the study.
排除标准
- •Acute metabolic complications (diabetic ketoacidosis, hyperosmolar hyperglycemia associated with dehydration).
- •Acute complications of chronic cardiovascular, neurological, renal, and other diabetic complications.
- •Any subject with unstable vitals signs (temperature > 101 degrees F, systolic blood pressure < 90 or > 180 mm hg, diastolic blood pressure < 60 or > 110 mm hg, heart rate < 60 or > 120 beats/minute).
- •Electrolyte imbalances (serum bicarbonate level < 20 mEq/L, serum sodium < 125 & > 150 mEq/L, serum potassium < 3.5 & > 5.5 mEq/L).
- •Evidence of an impaired sensorium and/or dementia.
- •Age > 75 years
- •Subjects with any acute medical illness.
- •Type 1 diabetes or type 2 diabetics weighing less than 120 lbs
- •Current addiction to illicit substances or alcohol abuse
- •Pregnant or lactating subjects
研究组 & 干预措施
Glipizide arm
Glipizide XL is an insulin secretagogue and is an extended release tablet designed to provide a controlled rate of delivery. Glipizide XL was chosen because it is the most frequently used discharge oral medication in our ED. It has a quick onset of action within a few hours after oral ingestion, lasts for 24 hours and has a powerful glucose lowering effect. In addition, there are very few contraindications to Glipizide XL and there is published literature regarding their use in subjects with severe hyperglycemia
干预措施: Glipizide (Drug)
Glipizide + Glargine
Insulin Glargine is a recombinant human basal insulin analog. It was chosen since it is a non-peaking insulin with cover for 24 hours. It can be injected subcutaneously only once a day and has a low incidence of hypoglycemia
干预措施: Glipizide and Glargine (Drug)
结局指标
主要结局
The primary outcome was the patients' ability to avoid repeat ED visits or hospitalization in either of the discharge regimens.
时间窗: 2 months
次要结局
- The secondary outcomes included the number of subjects who reached a fasting or pre-meal BG goal of 80 to 130 mg/dl and assessment of the beta cell function at the beginning and end of the study as measured by C-peptide levels during OGTT testing.(2 months)