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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-06-30

Brief Summary

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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

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Conditions

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Type 1 Diabetes Mellitus

Keywords

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type 1 diabetes mellitus hypoglycaemia insulin profiles growth hormone cortisol glucagon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Insulin NovoRapid versus Actrapid

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Iben B. Jacobsen, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Diabetes Research Center

Odense, Funen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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007

Identifier Type: -

Identifier Source: org_study_id