Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX) (IOOX)
2009년 12월 4일 업데이트: Eli Lilly and Company
Comparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture With Separate Basal and Bolus Insulin Injections
A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.
연구 개요
연구 유형
중재적
등록 (실제)
484
단계
- 4단계
연락처 및 위치
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연구 장소
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Goyang-Si/Kyunggi-Do, 대한민국, 410-719
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Kwang Ju, 대한민국, 501-757
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Seoul, 대한민국, 110-746
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Arkhangelsk, 러시아 연방, 163045
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Moscow, 러시아 연방, 117036
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Saint Petersburg, 러시아 연방, 193257
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Chihuahua, 멕시코, 31238
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Guadalajara, 멕시코, 44620
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Alicante, 스페인, 03114
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Almeria, 스페인, 04001
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Barcelona, 스페인, 08017
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Bilbao, 스페인, 48013
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Malaga, 스페인, 29010
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Ontario
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London, Ontario, 캐나다, N6A 4L2
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Quebec
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Granby, Quebec, 캐나다, J2G 1T7
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Sherbrooke, Quebec, 캐나다, J1G 5K2
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Saskatchewan
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Regina, Saskatchewan, 캐나다, S4P 0W5
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Mantes La Jolie, 프랑스, 78200
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Menton, 프랑스, 06500
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Pau, 프랑스, 64000
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Poitiers, 프랑스, 86000
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Toulouse, 프랑스, 31082
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South Australia
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Keswick, South Australia, 호주, 5035
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Victoria
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Fitzroy, Victoria, 호주, 3065
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Western Australia
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Fremantle, Western Australia, 호주, 6160
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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
30년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Have type 2 diabetes
- Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label
- Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.
Exclusion Criteria:
- Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.
- Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.
- Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.
- Have a body mass index greater than 40 kg/m2.
- Have had more than one episode of severe hypoglycemia in the last24 weeks
- Are pregnant, intend to be pregnant during the course of the study or are breastfeeding
- Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease
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 |
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실험적: Insulin Lispro Mid Mixture
Insulin lispro mid mixture (MM) up to three times a day (TID)
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Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks
다른 이름들:
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활성 비교기: Insulin Glargine
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
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Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hemoglobin A1c (HbA1c) at 36 Week Endpoint
기간: 36 weeks
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Level of hemoglobin A1c at endpoint.
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36 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hemoglobin A1c (HbA1c) at Interval Visits
기간: 12, 24, and 36 weeks
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Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.
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12, 24, and 36 weeks
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Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
기간: 12-24-36 weeks
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12-24-36 weeks
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7-point Self-monitored Blood Glucose Profiles
기간: Baseline, 12-24-36 weeks
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Actual daily mean blood glucose levels at specified time points.
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Baseline, 12-24-36 weeks
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Glycemic Variability
기간: Baseline, 12-24-36 weeks
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Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.
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Baseline, 12-24-36 weeks
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Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
기간: Baseline to 36 Weeks
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Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines.
Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking.
Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime.
Overall episodes: those that occurred at any time during the post-randomization visits.
Endpoint: last visit interval based on LOCF.
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Baseline to 36 Weeks
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30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
기간: Baseline to 36 Weeks
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Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines.
Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking.
Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime.
Overall episodes: those that occurred at any time during the post-randomization visits.
Endpoint: last visit interval based on LOCF.
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Baseline to 36 Weeks
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Number of Patients With at Least One Severe Hypoglycemia Episode
기간: Baseline to 36 Weeks
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Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose <2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident.
The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits.
Endpoint: last visit interval based on LOCF.
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Baseline to 36 Weeks
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Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial
기간: 36 Weeks
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Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day [U/kg/day]) was assessed.
Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations.
Prandial insulin is taken at meal time.
Insulin glargine is a basal insulin and insulin lispro is a prandial insulin.
Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro.
Endpoint: last visit interval based on LOCF.
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36 Weeks
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Endpoint Insulin Dose; Total, Basal, and Prandial
기간: 36 Weeks
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Total daily insulin dose (Units of insulin per day [U/day]) was assessed.
Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations.
Prandial insulin is taken at meal time.
Insulin glargine is a basal insulin and insulin lispro is a prandial insulin.
Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro.
Endpoint: last visit interval based on LOCF.
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36 Weeks
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Number of Insulin Injections Per Day
기간: Weeks 12, 24, 30, 36
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Weeks 12, 24, 30, 36
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Change From Baseline in Absolute Body Weight at 36 Week Endpoint
기간: Baseline, 36 Weeks
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Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.
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Baseline, 36 Weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 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
2006년 8월 1일
기본 완료 (실제)
2008년 9월 1일
연구 완료 (실제)
2008년 9월 1일
연구 등록 날짜
최초 제출
2006년 9월 11일
QC 기준을 충족하는 최초 제출
2006년 9월 14일
처음 게시됨 (추정)
2006년 9월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2009년 12월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2009년 12월 4일
마지막으로 확인됨
2009년 12월 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. .