Status:

UNKNOWN

Insulin NovoRapid Versus Actrapid in Treatment of Type 1 Diabetic Patients During Daily Adjustment of Insulin Dose

Lead Sponsor:

Odense University Hospital

Conditions:

Type 1 Diabetes Mellitus

Eligibility:

All Genders

18-60 years

Phase:

PHASE4

Brief Summary

The main purpose of the study is to investigate the reason for the reduced number of hypoglycaemic attacks in type 1 diabetic patients when, for a period of time, using Insulin Aspart at meals togethe...

Eligibility Criteria

Inclusion

  • Type 1 diabetes mellitus treated with insulin four times daily (basal bolus treatment) at least three months before screening.
  • AGe: 18-60 years
  • BMI: 18-27.5
  • No nefro- or neuropathy; i.e. S-creatinin below 120 μmol/l and normal monofilament examination
  • Written informed consent

Exclusion

  • Pregnant women or patients planning to become pregnant during the investigation period
  • Reduced eyesight; i.e. visus \> 0.3 evaluated at the latest eye exam.
  • Patient lacking the ability to sens insulin sensitivity
  • Serious rival disease, i.e. heart disease, severe liver or lung impairment, severe psychiatric disease.
  • Suspicion of abuse or non-compliance
  • Participation in another clinical trial

Key Trial Info

Start Date :

November 1 2004

Trial Type :

INTERVENTIONAL

End Date :

June 1 2006

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT00145353

Start Date

November 1 2004

End Date

June 1 2006

Last Update

October 11 2006

Active Locations (1)

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1

Diabetes Research Center

Odense, Funen, Denmark, 5000