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临床试验/NCT01963728
NCT01963728终止4 期

Comparison of Insulin Isophane (NPH) With Insulin Glargine in New Onset Diabetes After Transplant (NODAT)

Inova Health Care Services1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2013年11月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
2
试验地点
1
主要终点
Change in Hemoglobin A1C (Glycosylated Hemoglobin)

研究概览

简要总结

To determine if the use of insulin isophane results in improved control of blood sugars compared to the use of insulin glargine in new onset diabetes after kidney, lung, or heart transplantation (NODAT).

详细描述

A large percentage of organ transplant recipients develop de novo diabetes mellitus after transplantation, also called "New Onset Diabetes After Transplant" or NODAT. The cause of the diabetes appears to be commonly used anti-rejection medications, particularly calcineurin inhibitors and glucocorticoids.

Management of glucose levels in NODAT often requires insulin therapy. Standard practice is to start long-acting insulin. However, patients with NODAT often exhibit fasting morning glucose levels that are relatively low compared to pre-lunch and pre-dinner glucose levels. This seems to make NODAT patients more susceptible to fasting, or morning, hypoglycemia on long-acting insulin analogues than non-transplant patients with type II diabetes. This phenomenon of morning hypoglycemia in NODAT often limits the up-titration of basal insulin resulting in suboptimal treatment of hyperglycemia later in the day. Because of this pattern, transplant patients may respond better to morning insulin isophane (intermediate acting) than to long-acting insulin glargine preparations.

Our trial is designed to compare morning NPH insulin (isophane insulin) with conventional therapy of basal glargine insulin on both continuous blood glucose levels and hemoglobin A1c (glycosylated hemoglobin).

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

盲法说明

Subjects will be randomized to

  1. Insulin glargine (Lantus) or
  2. Insulin isophane (NPH)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be followed by the Inova Fairfax Hospital transplantation program for post-transplant care
  • Diabetes mellitus inadequately responsive to lifestyle modification and non-insulin hypoglycemic medication
  • Need for subcutaneous insulin therapy (after discontinuation of IV insulin therapy, if it was required)
  • Ability to read consent form and give consent in English.

排除标准

  • Use of insulin or non-insulin hypoglycemic medication before transplantation
  • Cystic fibrosis patients
  • Age < 18 years of age
  • Non-English speaking subjects

研究组 & 干预措施

insulin isophane

Active Comparator

daily dose will be titrated based on fasting morning glucose values

干预措施: Insulin, Isophane (Drug)

insulin glargine

Active Comparator

daily dose will be titrated based on fasting morning glucose values

干预措施: insulin glargine (Drug)

结局指标

主要结局

Change in Hemoglobin A1C (Glycosylated Hemoglobin)

时间窗: at 6 months post enrollment

次要结局

  • Mean Blood Glucose Values(3 and 6 months post enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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