MedTrace Logo

Insulin Effects on Metabolism and Cardiovascular Function in Type 2 Diabetes

NCT00747409 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2008-09-05

No results posted yet for this study

Summary

Compared to human insulins analogue insulins offer the option of optimizing metabolism also in type 2 diabetes. Especially, fast acting insulin analogues lower postprandial glucose levels more effectively than human regular insulin. However, it is not known whether therapy with analogue insulins can also improve the subclinically impaired myocardial function in type 2 diabetes. This prospective, randomized, open long term study compared the effects of a basal-bolus insulin therapy with analogue insulins versus human insulins on metabolic control and systolic and diastolic myocardial function, testing the hypothesis that optimized postprandial glucose control improves cardiac function and cardiovascular risk.

Conditions

Interventions

DRUG

insulin aspart and detemir (NovoRapid, Levemir)

use of basal-bolus therapy with insulin aspart and detemir

DRUG

human regular insulin and NPH insulin (Actrapid, Protaphne)

basal-bolus therapy with human regular and NPH insulin

Sponsors & Collaborators

Principal Investigators

  • Petra-Maria Schumm-Draeger, MD, PHD · Munich Academic Teaching Hospital Bogenhausen

  • Helene von Bibra, MD, PHD · Munich Academic Teaching Hospital Bogenhausen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2009-03-31
Completion
2009-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00747409 on ClinicalTrials.gov