- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01792323
Absorption of Insulin Following Subcutaneous Bolus Administration With Different Bolus Durations
Subcutaneous Insulin Absorption Following Bolus Administrations With an Insulin Pump - Comparison of Bolus Administrations With Different Bolus Durations
To cover meal-related insulin requirements, insulin pumps allow insulin to be delivered at high rates over a short period of time (bolus delivery). The length of this period (bolus duration) usually depends on the chosen bolus size and on the used insulin pump model. This study will evaluate the impact of different bolus durations (i.e., durations commonly employed in commercially available insulin pumps: 2 and 40 seconds for delivering 1 Unit of insulin) on the pharmacokinetic and pharmacodynamic properties of an rapid-acting insulin analogue.
Objective: To evaluate in type 1 diabetic patients the pharmacodynamics and pharmacokinetics of rapid-acting insulin (insulin lispro) administered as subcutaneous boluses with different bolus durations.
Study design: Single-center, randomized, controlled, two-arm cross-over intervention study
Population: Twenty type 1 diabetic subjects
Intervention: The investigational treatment is the subcutaneous administration of insulin lispro either as one bolus of 15 IU over a period of 30s or as one bolus of 15 IU over a period of 10 min. Plasma samples to assess pharmacodynamic and pharmacokinetic properties will be taken during an 8-hour clamp experiment. Patients will undergo both investigational treatments in a randomized order; between the two clamp visits there will be a wash-out period of 5-21 days.
Main study endpoint: Time to maximum glucose infusion rate
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Styria
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Graz, Styria, 오스트리아, A-8036
- Medical University of Graz
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Informed consent obtained after being advised of the nature of the study
- Male or female aged 18-60 years (both inclusive)
- Type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months
- Fasting C-peptide < 0.3nmol/L
- Body mass index 20.0-30.0 kg/m² (both inclusive)
- HbA1c < 10%
Exclusion Criteria:
- Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
- Skin pathology or condition prohibiting needle insertion/insulin administration as judged by the investigator
- History of bleeding disorder
- Current participation in another clinical study
- Use of insulin lispro >2 weeks
- Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the investigator
- Smoker (defined as >5 cigarettes/d)
- Lipodystrophy
- Current treatment with systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone, herbal products or non-routine vitamins. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months
- Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen
Study Day Exclusion Criteria:
- Strenuous exercise within the last 24 hours prior to the clamp visit
- Non-fasting (i.e. consumption of food or beverages, other than water, later than 22:00 hours the evening before the visit) except if slight intake of rapidly absorbable carbohydrates has been necessary in order to prevent hypoglycaemia
- Injection of long-acting insulin (e.g. insulin glargine or insulin detemir) later than 12:00 hours (noon), 2 days before the clamp visit
- Injection of NPH insulin or other intermediate-acting insulin products later than 12:00 hours (noon) on the day before the clamp visit
- Injection of any short acting insulin (aspart, lispro, glulisine) or more than 6 IU of human insulin between 22:00 hours and 03:00 hours the night before the clamp visit
- Injection of any insulin later than 03:00 hours the night before the clamp visit
- Infusion of any insulin later than 03:00 hours the night before the clamp visit for subjects using continuous subcutaneous insulin infusion (CSII)
- Positive result of alcohol breath test
- Any medical condition that, in the opinion of the Investigator, could interfere with insulin pharmacokinetics and/or glucose metabolism
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 1 bolus of insulin lispro with short bolus duration
Subcutaneous administration of insulin lispro as a bolus of 15 IU over a period of 30 seconds
|
Administration of 15 IU of insulin lispro over a period of 30 seconds
|
실험적: 1 bolus of insulin lispro with long bolus duration
Subcutaneous administration of insulin lispro as a bolus of 15 IU over a period of 10 minutes
|
Administration of 15 IU of insulin lispro over a period of 30 seconds
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
tmax(GIR); time to maximum glucose infusion rate
기간: 8 hours
|
8 hours
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2차 결과 측정
결과 측정 |
기간 |
---|---|
GIRmax, maximum glucose infusion rate
기간: 8 hours
|
8 hours
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기타 결과 측정
결과 측정 |
기간 |
---|---|
tmax(ins), time to maximum observed plasma insulin lispro concentration
기간: 8 hours
|
8 hours
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공동 작업자 및 조사자
수사관
- 수석 연구원: Thomas R Pieber, MD, Medical University of Graz, Internal Medicine, Endocrinology and Metabolism
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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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