NCT00145353

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

October 11, 2006

Status Verified

October 1, 2006

First QC Date

September 2, 2005

Last Update Submit

October 10, 2006

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes mellitushypoglycaemiainsulin profilesgrowth hormonecortisolglucagon

Outcome Measures

Primary Outcomes (1)

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

Interventions

Insulin NovoRapid versus ActrapidDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Research Center

Odense, Funen, 5000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Iben B. Jacobsen, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

November 1, 2004

Study Completion

June 1, 2006

Last Updated

October 11, 2006

Record last verified: 2006-10

Locations

DK(1)