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

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Primary Purpose

Status

Unknown status

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Insulin NovoRapid versus Actrapid

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring type 1 diabetes mellitus, hypoglycaemia, insulin profiles, growth hormone, cortisol, glucagon

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Diabetes Research Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00145353

First Posted

September 2, 2005

Last Updated

October 10, 2006

Sponsor

Odense University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00145353

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2006

Overall Recruitment Status

Unknown status

Study Start Date

November 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Odense University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes mellitus, hypoglycaemia, insulin profiles, growth hormone, cortisol, glucagon

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

16 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Insulin NovoRapid versus Actrapid

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Iben B. Jacobsen, MD

Organizational Affiliation

Odense University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Diabetes Research Center

City

Odense

State/Province

Funen

ZIP/Postal Code

5000

Country

Denmark

Type 1 Diabetes Mellitus

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial