Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide
2011年1月12日 更新者：Eli Lilly and Company
A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide
This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.
研究概览
研究类型
介入性
注册 (实际的)
339
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ponce、波多黎各、00731
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Toa Baja、波多黎各、00949
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Yabucoa、波多黎各、00767
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Arizona
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Phoenix、Arizona、美国、85028
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California
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Concord、California、美国、94520
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Escondido、California、美国、92026
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Fresno、California、美国、93720
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Modesto、California、美国、95355
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Orange、California、美国、92869
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Florida
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Inverness、Florida、美国、34452
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Jacksonville、Florida、美国、32204
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Lake Worth、Florida、美国、33461
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Miami、Florida、美国、33183
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Orlando、Florida、美国、32804
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Palm Harbor、Florida、美国、34684
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Pembroke Pines、Florida、美国、33029
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Plantation、Florida、美国、33324
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West Palm Beach、Florida、美国、33401
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Hawaii
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Honolulu、Hawaii、美国、96813
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Idaho
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Idaho Falls、Idaho、美国、83404
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Indiana
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Avon、Indiana、美国、46123
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Bloomington、Indiana、美国、47403
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South Bend、Indiana、美国、46617
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Iowa
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Des Moines、Iowa、美国、50314
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Kentucky
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Lexington、Kentucky、美国、40503
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Louisiana
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Baton Rouge、Louisiana、美国、70808
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Lafayette、Louisiana、美国、70503
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Metairie、Louisiana、美国、70006
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Maine
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Biddeford、Maine、美国、04005
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Missouri
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Chesterfield、Missouri、美国、63017
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Jefferson City、Missouri、美国、65109
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St Louis、Missouri、美国、63104
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Nebraska
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Omaha、Nebraska、美国、68131
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Nevada
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Las Vegas、Nevada、美国、89148
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New Hampshire
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Nashua、New Hampshire、美国、03063
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New York
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Rochester、New York、美国、14607
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Syracuse、New York、美国、13210
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North Carolina
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Morehead City、North Carolina、美国、28557
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ohio
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London、Ohio、美国、43140
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Mason、Ohio、美国、45040
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Toledo、Ohio、美国、43606
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South Carolina
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Greer、South Carolina、美国、29651
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Myrtle Beach、South Carolina、美国、29572
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Tennessee
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Kingsport、Tennessee、美国、37660
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Memphis、Tennessee、美国、38119
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Texas
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Austin、Texas、美国、78731
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Dallas、Texas、美国、75231
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San Antonio、Texas、美国、78229
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Vermont
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South Burlington、Vermont、美国、05403
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Virginia
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Virginia Beach、Virginia、美国、23462
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Washington
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Spokane、Washington、美国、99202
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Vancouver、Washington、美国、98664
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 74年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Must have type 2 diabetes
- Must be at least 18 years of age and less than 75 years of age
- Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
- Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
- Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%
Exclusion Criteria:
- Must not have used insulin on a regular basis during the past 2 years
- Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
- Must not have had more than one episode of severe hypoglycemia in the past 6 months
- Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
- Must not be pregnant or intend to get pregnant during the course of the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：ILPS
Insulin Lispro Protamine Suspension (ILPS)
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Administered subcutaneously once a day at bedtime
其他名称：
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有源比较器：Glargine
Insulin Glargine
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Administered subcutaneously once a day at bedtime
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
大体时间：Baseline, Endpoint (LOCF) up to 24 weeks
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Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.
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Baseline, Endpoint (LOCF) up to 24 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
大体时间：24 weeks, Endpoint (LOCF) up to 24 weeks
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Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
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24 weeks, Endpoint (LOCF) up to 24 weeks
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Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
大体时间：Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
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Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
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Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
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Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
大体时间：Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
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Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
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7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
大体时间：Baseline, Endpoint (LOCF) up to 24 weeks
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SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours.
Post-prandial glucose is measured 2 hours after the start of the meal.
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Baseline, Endpoint (LOCF) up to 24 weeks
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Glycemic Variability at Baseline and Endpoint (LOCF)
大体时间：Baseline, Endpoint (LOCF) up to 24 weeks
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Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose.
Mean SD was calculated based on the SD for each participant in the study.
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Baseline, Endpoint (LOCF) up to 24 weeks
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Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
大体时间：Baseline to Endpoint (LOCF) up to 24 weeks
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Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL.
Non-nocturnal:any episode that occurred between waking and bedtime.
Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100.
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Baseline to Endpoint (LOCF) up to 24 weeks
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Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
大体时间：Baseline to Endpoint (LOCF) up to 24 weeks
|
Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall.
Rate is reported as episodes/participant/365 days.
Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment.
Overall=any time during the post-randomization visits within the study period.
Nocturnal=Any episode that occurs between bedtime and waking.
Non-Nocturnal=Any episode that occurs between waking and bedtime.
|
Baseline to Endpoint (LOCF) up to 24 weeks
|
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Actual Body Weight at Baseline and Endpoint (LOCF)
大体时间：Baseline, Endpoint (LOCF) up to 24 weeks
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
|
|
Change From Baseline in Body Weight at Endpoint (LOCF)
大体时间：Baseline, Endpoint (LOCF) up to 24 weeks
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
|
|
Total Daily Insulin Dose at Endpoint (LOCF)
大体时间：Endpoint (LOCF) up to 24 weeks
|
Endpoint (LOCF) up to 24 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年11月1日
初级完成 (实际的)
2009年12月1日
研究完成 (实际的)
2009年12月1日
研究注册日期
首次提交
2007年11月15日
首先提交符合 QC 标准的
2007年11月15日
首次发布 (估计)
2007年11月19日
研究记录更新
最后更新发布 (估计)
2011年1月13日
上次提交的符合 QC 标准的更新
2011年1月12日
最后验证
2011年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.