NCT00670722

Brief Summary

This study is conducted in Europe. An observational study evaluating the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment of Type 2 diabetes mellitus in Czech Republic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

April 30, 2008

Last Update Submit

October 27, 2016

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c after switch from human insulin to modern insulin treatment

    After 24 weeks

Secondary Outcomes (7)

  • Percentage of subjects to reach HbA1c below 7.0% and = 6.5% at approximately 12 weeks and 24 weeks of treatment

    After 12 and 24 weeks

  • Postprandial glycaemic control as measured by PPG

    After 12 and 24 weeks

  • Glucose variability as measured by FPG

    After 12 and 24 weeks

  • Insulin dose and number of injections

    After 12 and 24 weeks

  • Body weight

    After 12 and 24 weeks

  • +2 more secondary outcomes

Study Arms (4)

A

Drug: insulin aspart

B

Drug: insulin detemir

C

Drug: biphasic insulin aspart 30

D

Drug: insulin aspartDrug: insulin detemir

Interventions

insulin aspartDRUG

Intervention at the discretion of the physician

Also known as: NovoRapid®
AD
insulin detemirDRUG

Intervention at the discretion of the physician

BD
biphasic insulin aspart 30DRUG

Intervention at the discretion of the physician

C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Type 2 diabetes

You may qualify if:

  • Type 2 diabetes
  • Current treatment with human soluble insulin, insulin NPH or premixed human insulin
  • The selection of the subjects will be at the discretion of the individual physician

You may not qualify if:

  • Current treatment with insulin aspart, insulin detemir or biphasic insulin aspart 30
  • Previous enrolment in this study
  • Hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients.
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months and considered to be treated by biphasic insulin aspart 30 or insulin detemir

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Prague, 16000, Czechia

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin AspartInsulin Detemirinsulin aspart, insulin aspart protamine drug combination 30:70

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 ProteinsInsulin, Long-Acting

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2008

First Posted

May 2, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

CZ(1)