NCT00572806

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate if using insulin aspart as start therapy will improve the efficacy on daytime blood glucose cycle profile in subjects with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Feb 2003

Shorter than P25 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2003

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2004

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2007

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

12 months

First QC Date

December 12, 2007

Last Update Submit

February 22, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Blood glucose value

    at 5 pm in a daytime blood glucose cycle profile

Secondary Outcomes (3)

  • Evaluation of 24-hour blood glucose cycle

  • HbA1c

  • Hypoglycaemic episodes

Interventions

insulin aspartDRUG

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes for at least 3 years
  • HbA1c greater than 8.0%
  • Body Mass Index (BMI) below 40.0 kg/m2
  • Inadequate treatment with diet and OADs
  • Never received treatment with insulin

You may not qualify if:

  • Type 1 diabetes
  • Known or suspected allergy to investigational product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Montpellier, 34295, France

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 13, 2007

Study Start

February 5, 2003

Primary Completion

February 2, 2004

Study Completion

February 2, 2004

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

FR(1)