Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY) (IOOY)
2009년 11월 4일 업데이트: Eli Lilly and Company
Treat-to-Target Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Comparator) in Basal Therapy for Patients With Type 2 Diabetes Mellitus
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes.
A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
연구 개요
연구 유형
중재적
등록 (실제)
442
단계
- 3단계
연락처 및 위치
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연구 장소
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Chiayi City, 대만, 600
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Neihu Taipei, 대만, 114
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Tainan, 대만, 704
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Taipei, 대만, 100
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Yung-Kang, Tainan, 대만, 710
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Goyang-Si, 대한민국, 410-719
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Sungnam-Si, 대한민국, 463-712
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Chihuahua, 멕시코, 31238
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Guadalajara, 멕시코, 44340
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Alabama
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Hueytown, Alabama, 미국, 35023
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Arizona
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Litchfield Park, Arizona, 미국, 85340
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Phoenix, Arizona, 미국, 85016
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California
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Buena Park, California, 미국, 90620
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Fountain Valley, California, 미국, 92708
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Los Angeles, California, 미국, 90057
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Florida
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Jacksonville, Florida, 미국, 32257
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Georgia
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Atlanta, Georgia, 미국, 30312
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Illinois
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Chicago, Illinois, 미국, 60612
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Indiana
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Evansville, Indiana, 미국, 47714
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Indianapolis, Indiana, 미국, 46202
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Newburgh, Indiana, 미국, 47630
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Kentucky
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Lexington, Kentucky, 미국, 40503
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Louisiana
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Slidell, Louisiana, 미국, 70458
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Maryland
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Prince Frederick, Maryland, 미국, 20678
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Michigan
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Novi, Michigan, 미국, 48374
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Nevada
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Las Vegas, Nevada, 미국, 89101
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New York
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Syracuse, New York, 미국, 13210
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North Carolina
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Goldsboro, North Carolina, 미국, 27530
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Ohio
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Cincinnati, Ohio, 미국, 45236
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London, Ohio, 미국, 43140
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Oregon
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Bend, Oregon, 미국, 97701
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Pennsylvania
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Lansdale, Pennsylvania, 미국, 19446
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South Carolina
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Taylors, South Carolina, 미국, 29687
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Tennessee
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Johnson City, Tennessee, 미국, 37604
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Texas
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Grand Prairie, Texas, 미국, 75052
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Wisconsin
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Menomonee Falls, Wisconsin, 미국, 53051
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Lugo, 스페인, 27004
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Palma de Mallorca, 스페인, 07014
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Santa Cruz de Tenerife, 스페인, 38320
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Valencia, 스페인, 46015
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Buenos Aires, 아르헨티나, C1188AAF
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Ramos Mejia, 아르헨티나, B1704ETD
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Bangalore, 인도, 560052
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Chennai, 인도, 600086
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Cochin, 인도, 682026
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Mumbai, 인도, 400 067
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Pune, 인도, 411011
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Krakow, 폴란드, 30-349
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Poznan, 폴란드, 61-495
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Rzeszow, 폴란드, 35-068
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Budapest, 헝가리, H-1139
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Eger, 헝가리, 3300
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Mako, 헝가리, 6900
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Szekesfehervar, 헝가리, 8000
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Szekszard, 헝가리, 7100
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Veszprem, 헝가리, 8200
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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 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Have type 2 diabetes mellitus for at least 1 year.
- Are at least 18 years old.
- Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following: Metformin--1500 milligrams per day (mg/day); Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-intravenous (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
- Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
- Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).
Exclusion Criteria
- Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
- Have taken any glucose-lowering medications not included in Inclusion Criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
- Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
- Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter [micromol/L]).
- Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.
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 |
|---|---|
|
실험적: Insulin Lispro Protamine Suspension
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
|
Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
다른 이름들:
|
|
활성 비교기: Detemir
Detemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
|
Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
기간: Baseline, 24 Weeks
|
Baseline, 24 Weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
기간: Baseline to 24 Weeks
|
Overall: any time after randomization.
Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL.
Nocturnal: any hypoglycemic event that occurred between bedtime and waking.
Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.
|
Baseline to 24 Weeks
|
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Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks
기간: Baseline, 12 Weeks, 24 Weeks
|
Baseline, 12 Weeks, 24 Weeks
|
|
|
Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint
기간: 24 Weeks
|
Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7.0% and less than or equal to 6.5% at endpoint.
|
24 Weeks
|
|
Glycemic Variability
기간: 24 Weeks
|
Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose [SMBG] profiles at endpoint) for the actual morning pre-meal blood glucose value.
|
24 Weeks
|
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7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint
기간: 24 Weeks
|
Actual daily mean blood glucose levels at endpoint.
|
24 Weeks
|
|
Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods
기간: Baseline to 24 Weeks
|
Overall: any time after randomization.
Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL.
Nocturnal: any hypoglycemic event that occurred between bedtime and waking.
Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
Results are for the combined titration and maintenance periods.
|
Baseline to 24 Weeks
|
|
1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
기간: Baseline to 24 Weeks
|
Overall: any time after randomization.
Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL.
Nocturnal: any hypoglycemic event that occurred between bedtime and waking.
Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.
|
Baseline to 24 Weeks
|
|
Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint
기간: Baseline, 24 Weeks
|
Baseline, 24 Weeks
|
|
|
Total Daily Insulin Dose (Units) at Endpoint
기간: 24 Weeks
|
Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).
|
24 Weeks
|
|
Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint
기간: 24 Weeks
|
Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (Units/kilograms).
|
24 Weeks
|
|
Number of Injections of Basal Insulin Analog at Endpoint
기간: 24 Weeks
|
24 Weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.
- Fogelfeld L, Dharmalingam M, Robling K, Jones C, Swanson D, Jacober S. A randomized, treat-to-target trial comparing insulin lispro protamine suspension and insulin detemir in insulin-naive patients with Type 2 diabetes. Diabet Med. 2010 Feb;27(2):181-8. doi: 10.1111/j.1464-5491.2009.02899.x.
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 8월 1일
기본 완료 (실제)
2008년 9월 1일
연구 완료 (실제)
2008년 9월 1일
연구 등록 날짜
최초 제출
2007년 6월 27일
QC 기준을 충족하는 최초 제출
2007년 6월 27일
처음 게시됨 (추정)
2007년 6월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2009년 11월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2009년 11월 4일
마지막으로 확인됨
2009년 11월 1일
추가 정보
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. .