Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide
2011년 1월 12일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
339
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Arizona
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Phoenix, Arizona, 미국, 85028
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California
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Concord, California, 미국, 94520
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Escondido, California, 미국, 92026
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Fresno, California, 미국, 93720
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Modesto, California, 미국, 95355
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Orange, California, 미국, 92869
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Florida
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Inverness, Florida, 미국, 34452
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Jacksonville, Florida, 미국, 32204
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Lake Worth, Florida, 미국, 33461
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Miami, Florida, 미국, 33183
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Orlando, Florida, 미국, 32804
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Palm Harbor, Florida, 미국, 34684
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Pembroke Pines, Florida, 미국, 33029
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Plantation, Florida, 미국, 33324
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West Palm Beach, Florida, 미국, 33401
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Hawaii
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Honolulu, Hawaii, 미국, 96813
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Idaho
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Idaho Falls, Idaho, 미국, 83404
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Indiana
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Avon, Indiana, 미국, 46123
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Bloomington, Indiana, 미국, 47403
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South Bend, Indiana, 미국, 46617
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Iowa
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Des Moines, Iowa, 미국, 50314
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Kentucky
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Lexington, Kentucky, 미국, 40503
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Louisiana
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Baton Rouge, Louisiana, 미국, 70808
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Lafayette, Louisiana, 미국, 70503
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Metairie, Louisiana, 미국, 70006
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Maine
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Biddeford, Maine, 미국, 04005
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Missouri
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Chesterfield, Missouri, 미국, 63017
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Jefferson City, Missouri, 미국, 65109
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St Louis, Missouri, 미국, 63104
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Nebraska
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Omaha, Nebraska, 미국, 68131
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Nevada
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Las Vegas, Nevada, 미국, 89148
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New Hampshire
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Nashua, New Hampshire, 미국, 03063
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New York
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Rochester, New York, 미국, 14607
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Syracuse, New York, 미국, 13210
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North Carolina
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Morehead City, North Carolina, 미국, 28557
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Ohio
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London, Ohio, 미국, 43140
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Mason, Ohio, 미국, 45040
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Toledo, Ohio, 미국, 43606
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South Carolina
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Greer, South Carolina, 미국, 29651
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Myrtle Beach, South Carolina, 미국, 29572
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Tennessee
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Kingsport, Tennessee, 미국, 37660
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Memphis, Tennessee, 미국, 38119
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Texas
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Austin, Texas, 미국, 78731
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Dallas, Texas, 미국, 75231
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San Antonio, Texas, 미국, 78229
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Vermont
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South Burlington, Vermont, 미국, 05403
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Virginia
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Virginia Beach, Virginia, 미국, 23462
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Washington
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Spokane, Washington, 미국, 99202
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Vancouver, Washington, 미국, 98664
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Ponce, 푸에르토 리코, 00731
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Toa Baja, 푸에르토 리코, 00949
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Yabucoa, 푸에르토 리코, 00767
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: ILPS
Insulin Lispro Protamine Suspension (ILPS)
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Administered subcutaneously once a day at bedtime
다른 이름들:
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활성 비교기: Glargine
Insulin Glargine
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Administered subcutaneously once a day at bedtime
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
기간: 24 weeks, Endpoint (LOCF) up to 24 weeks
|
Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
|
24 weeks, Endpoint (LOCF) up to 24 weeks
|
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Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
기간: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
|
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%
기간: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
|
Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
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|
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7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
기간: Baseline, Endpoint (LOCF) up to 24 weeks
|
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.
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
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Glycemic Variability at Baseline and Endpoint (LOCF)
기간: Baseline, Endpoint (LOCF) up to 24 weeks
|
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.
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
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Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
기간: Baseline to Endpoint (LOCF) up to 24 weeks
|
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.
|
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)
기간: 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)
기간: Baseline, Endpoint (LOCF) up to 24 weeks
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
|
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Change From Baseline in Body Weight at Endpoint (LOCF)
기간: Baseline, Endpoint (LOCF) up to 24 weeks
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
|
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Total Daily Insulin Dose at Endpoint (LOCF)
기간: Endpoint (LOCF) up to 24 weeks
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Endpoint (LOCF) up to 24 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2007년 11월 1일
기본 완료 (실제)
2009년 12월 1일
연구 완료 (실제)
2009년 12월 1일
연구 등록 날짜
최초 제출
2007년 11월 15일
QC 기준을 충족하는 최초 제출
2007년 11월 15일
처음 게시됨 (추정)
2007년 11월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2011년 1월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2011년 1월 12일
마지막으로 확인됨
2011년 1월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 11647
- F3Z-US-IOPB (기타 식별자: Eli Lilly and Company)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
제2형 당뇨병에 대한 임상 시험
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Postgraduate Institute of Medical Education and...완전한
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Hangzhou SynRx Therapeutics Biomedical Technology...모병유방암 | 난소 암 | 고급 고형 종양 | 전이성 고형 종양 | BRCA 1/2 및/또는 HRD중국