MedTrace Logo

Insulin Analogues and Severe Hypoglycaemia

NCT00346996 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2012-09-03

No results posted yet for this study

Summary

Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated. In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised to receive analogue and human insulin for one year in random order. Outcomes will be number of episodes of severe hypoglycaemia

Conditions

Interventions

DRUG

insulin levemir / aspart

for subcutaneous injection

DRUG

human insulin /insulin isophane

for subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Lise Tarnow, MD · Steno Diabetes Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2011-11-30
Completion
2012-08-31

Countries

  • Denmark

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 NCT00346996 on ClinicalTrials.gov