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Effect of Insulin Glulisine vs Regular Human Insulin on Postprandial Endothelial Function in Type 2 Diabetes

NCT00562133 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2007-11-21

No results posted yet for this study

Summary

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)

Conditions

Interventions

DRUG

Insulin Glulisine

100 IU/ml, 0.10 U/kg immediately before ingestion of a standardised liquid meal

DRUG

Insulin

100 IU/ml, 0.10 U/kg 15 Minutes before ingestion of a standardised liquid meal

Sponsors & Collaborators

  • IKFE Institute for Clinical Research and Development

    lead OTHER

Principal Investigators

  • Thomas A Forst, Prof, MD · Institute for Clinical Research and Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Completion
2007-03-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00562133 on ClinicalTrials.gov