Effect of Insulin Glulisine vs Regular Human Insulin on Postprandial Endothelial Function in Type 2 Diabetes
Effect of Prandial Treatment With Insulin Glulisine Compared to Regular Human Insulin on Postprandial Endothelial Function and Microvascular Stress in Type 2 Diabetic Patients
The primary objective of the study is to evaluate the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin.
The secondary objectives are to evaluate the postprandial time course of the following efficacy parameters after injection of insulin glulisine compared with regular insulin on
- Blood Glucose
- Insulin
- Intact proinsulin
- Asymmetric dimethylarginine (ADMA)
- Metal matrix proteasis (MMP-9)
- Oxidative status (per ox)
- Interleukin 18 (IL-18)
- Free fatty acids (FFA)
- Oxidised LDL (ox-LDL)
- Microvascular blood circulation measured with laser Doppler at 37 °C (LDF37)
- Microvascular blood circulation measured with laser Doppler at 44 °C (LDF44)
연구 개요
상세 설명
Phase III b Indication Type 2 Diabetes Trial Objectives 1) Primary objective: The primary objective of the study is to evaluate the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin. 2) Secondary objectives: The secondary objectives are to evaluate the postprandial time course of blood glucose, insulin, intact proinsulin, asymmetric dimethylarginine (ADMA), metal matrix proteasis (MMP-9), free fatty acids (FFA), oxidised LDL (ox-LDL), oxidative status (per ox), IL-18 as well as postprandial time course of microvascular blood circulation measured with laserdopplerflux at 37 °C (LDF37) and 44 C (LDF44).
Efficacy Variables Primary efficacy variablePostprandial time course of nitrotyrosineSecondary efficacy variablePostprandial time course of glucose, insulin, intact proinsulin, ADMA, MMP-9, FFA, ox-LDL, per-ox, and IL-18 as well as postprandial time course of laserdopplerflux at 37 °C and 44 °C Safety Variables Incidence and frequency of adverse events and evaluation of safety laboratory parameters Medication/Dosage Insulin glulisine, dose 0.10 U/kg and Regular Human Insulin, dose 0.10 U/kg Study Duration Duration of study participation for one patient: 5 - 43 days Overall duration of the study: 6 months Design Single-centre, open label, randomized, 2-way-crossover trial Population Male and female type 2 diabetic patients between 40 and 70 years with HbA1c between 6.5 % and 9.9 % and treated with sulfonyurea alone or in combination with Metformin in a stable dosage within the last 3 months Sample Size N = 15
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Rhineland-Palatinate
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Mainz, Rhineland-Palatinate, 독일, 55116
- Ikfe
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Type 2 Diabetes mellitus according to the ADA criteria
- HbA1c between 6.5 % and 9.9 %
- Monotherapy with sulfonylurea or combined with Metformin in a stable dosage within the last 3 months
- Age between 40 and 70 years
- BMI < 40
Exclusion Criteria:
- Type 1 Diabetes mellitus
- Pre-Treatment with insulin within the last 6 months prior to screening
- Treatment with glitazones within the last 6 months prior to screening
- Pre-Treatment with PPARy-agonists, glinides or glucosidase inhibitors within the last 4 weeks prior to screening
- Untreated hypertension stage II-III according to WHO criteria
- Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
- Total Cholesterol > 300 mg/dl (anamnestically)
- Hypokalemia (K < 3.5 mmol /l)
- Major micro- or macrovascular complications as judged by the investigator
- Tobacco use within the last 12 months prior to screening
- Drugs with major impact on endothelial function like nitrates etc.
- History of drug or alcohol abuse within the last five years prior to screening
- Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- History of severe or multiple allergies
- Treatment with any other investigational drug within 3 months prior to screening
- Progressive fatal disease
- History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.1 mg/dL in women, > 1.5 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator
- Pregnancy or breast feeding
- Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
- Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 1
One Day Treatment with Insulin Glulisine
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100 IU/ml, 0.10 U/kg immediately before ingestion of a standardised liquid meal
다른 이름들:
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활성 비교기: 2
One day Treatment with Human insulin
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100 IU/ml, 0.10 U/kg 15 Minutes before ingestion of a standardised liquid meal
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin
기간: 1 day
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1 day
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
postprandial time course of blood glucose, insulin, intact proinsulin, ADMA, MMP-9, FFA, ox-LDL, per ox Status, IL-18, postprandial time course of microvascular blood circulation measured with laserdopplerflux at 37 °C and 44 C
기간: 1 day
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1 day
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공동 작업자 및 조사자
수사관
- 수석 연구원: Thomas A Forst, Prof, MD, Institute for Clinical Research and Development
연구 기록 날짜
연구 주요 날짜
연구 시작
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- APIDR_L_01896
- EudraCT Number 2006-005127-42
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