Lispro Mid Mixture (MM) Intensive Mixture Therapy With Progressive Dose-Titration of Lispro Low Mixture (LM) or Biphasic Insulin Aspart 30/70 (S019) (S019)
2010년 7월 15일 업데이트: Eli Lilly and Company
A Comparison of Insulin Lispro MM Intensive Mixture Therapy With Progressive Dose-Titration of Insulin Lispro LM or Biphasic Insulin Aspart 30/70
Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations twice daily and metformin will be randomly assigned to follow one of two insulin treatment strategies used in combination with metformin administration.
The aim of the trial is to try to achieve optimal metabolic control and explore full therapeutic potential of the strategies, patients in both arms will follow progressive insulin dose titration algorithms for 16 weeks.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
302
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Kempton Park, 남아프리카, 1619
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Kenilworth, 남아프리카, 7708
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Kuilsriver, 남아프리카, 7580
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Bucharest, 루마니아, 020475
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Istanbul, 칠면조, 34662
- 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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Konya, 칠면조, 42075
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Zagreb, 크로아티아, HR-10000
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Bialystok, 폴란드, 15-276
- 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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Rzeszow, 폴란드, 35-0723
- 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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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 (World Health Organization [WHO] classification).
- Are at least 30 years of age and less than 75 years of age.
- Have been receiving hypoglycemic treatment with premixed insulin analogue (either with insulin lispro LM or biphasic insulin aspart 30/70) administered twice daily in combination with at least 1500 milligrams (mg) of metformin per day for at least 60 days immediately prior to the study.
- Have a hemoglobin A1c 1.2 to 1.8 times the upper limit of the normal reference range at the local laboratory at Visit 1 or
- Have at least 6 of 9 of the postprandial blood glucose values recorded in the period between Visit 1 and Visit 2 exceeding 180 milligrams per 100 milliliters (mg/dl) (10.0 millimole per liter [mmol/l]).
- Have given written informed consent to participate in this study in accordance with local regulations.
Exclusion Criteria:
- Are taking any other oral anti-diabetic medication (OAM) not mentioned in inclusion criterion.
- Have a body mass index greater than 40 kilograms per meter squared (kg/m2).
- Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
- Have congestive heart failure.
- Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night).
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 LM + insulin lispro MM
Three times per day subcutaneous injection of insulin lispro mid mixture (MM) with the possibility to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.
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Participant adjusted dose, injected subcutaneously for 16 weeks - possibility of using instead of insulin lispro MM before evening meal if there is a risk of hypoglycemia after the dinner or high fasting glucose levels.
다른 이름들:
Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks
다른 이름들:
Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks
다른 이름들:
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활성 비교기: Insulin Biphasic Aspart 30/70 or Insulin Lispro LM
Twice daily subcutaneous injection of either insulin biphasic aspart 30/70 or insulin lispro low mixture (LM) (continuation of analogue formulation used before study enrollment).
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Participant adjusted dose, injected subcutaneously for 16 weeks - possibility of using instead of insulin lispro MM before evening meal if there is a risk of hypoglycemia after the dinner or high fasting glucose levels.
다른 이름들:
Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks
다른 이름들:
Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Hemoglobin A1c (HbA1c) at 16 Week Endpoint
기간: 16 weeks
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16 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint
기간: 16 weeks
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16 weeks
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Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint
기간: Baseline, 16 Weeks
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Baseline, 16 Weeks
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2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint
기간: 16 weeks
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Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement.
Results presented here are for the blood glucose concentrations 2-hours after the midday meal at Week 16.
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16 weeks
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Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint
기간: 16 weeks
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Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement.
Results presented here are for the difference (excursion) between midday premeal and 2-hour postprandial midday meal blood glucose concentrations at Week 16.
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16 weeks
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Mean Daily Blood Glucose Values at 16 Week Endpoint
기간: 16 weeks
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16 weeks
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Number of Patients With Self-reported Hypoglycemic Episodes
기간: Baseline through 16 weeks
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Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL.
Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin.
Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.
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Baseline through 16 weeks
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30-Day Adjusted Rate of Hypoglycemic Events
기간: Baseline through 16 weeks
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Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL.
Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin.
Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.
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Baseline through 16 weeks
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Change From Baseline in Weight at 16 Week Endpoint
기간: Baseline, 16 weeks
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Baseline, 16 weeks
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Total Daily Insulin Dose at 4 Weeks and 12 Weeks
기간: 4 weeks and 12 weeks
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4 weeks and 12 weeks
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
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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 10월 1일
기본 완료 (실제)
2009년 3월 1일
연구 완료 (실제)
2009년 3월 1일
연구 등록 날짜
최초 제출
2006년 10월 26일
QC 기준을 충족하는 최초 제출
2006년 10월 26일
처음 게시됨 (추정)
2006년 10월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2010년 7월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2010년 7월 15일
마지막으로 확인됨
2010년 7월 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. .
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