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

Odense University Hospital

Status and phase

Unknown

Phase 4

Conditions

Type 1 Diabetes Mellitus

Treatments

Drug: Insulin NovoRapid versus Actrapid

Study type

Interventional

Funder types

Other

Identifiers

NCT00145353

007

Details and patient eligibility

About

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 together with NPH insulin mornings and evenings, and when, in another period of time, using human fast-working insulin at meals and NPH insulin mornings and evenings, and when the patients in both periods simultaneously take extra insulin at meals if high blood glucose values are found before meals.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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