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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Is Insulin NovoRapid Better Than Actrapid for Treating Type 1 Diabetic Patients When Simultaneously, Daily Adjusting the Insulin Dose?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00145353
• Other study ID #: 007
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 2, 2005
• Last updated: October 10, 2006
• Start date: November 2004
• Est. completion date: June 2006

Study information

• Verified date: October 2006
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Insulin NovoRapid versus Actrapid

Locations

Country	Name	City	State
Denmark	Diabetes Research Center	Odense	Funen

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meal-regulated insulin time two peaks after the two intervention periods