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

Tracking Information

First Received Date ^ICMJE

September 2, 2005

Last Updated Date

October 10, 2006

Start Date ^ICMJE

November 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Meal-regulated insulin time two peaks after the two intervention periods

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00145353 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Type 1 Diabetes Mellitus

Intervention ^ICMJE

Drug: Insulin NovoRapid versus Actrapid

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

June 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00145353

Responsible Party

Study ID Numbers ^ICMJE

007

Study Sponsor ^ICMJE

Odense University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Iben B. Jacobsen, MD

Odense University Hospital

Information Provided By

Odense University Hospital

Verification Date

October 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP