NCT00676741

Brief Summary

The study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for the treatment type 2 diabetes. Full acronym for this study: COMMIT - CLEAN SWITCH

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,809

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

Typical duration for all trials

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 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

2.2 years

First QC Date

May 9, 2008

Last Update Submit

October 27, 2016

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Metabolic control measured as HbA1c

    for the duration of the study

Secondary Outcomes (8)

  • Percentage of subjects achieving HbA1c below 7.0% and below or equal 6.5%

    after 12 weeks and 24 weeks

  • Change in FPG (glucose variability)

    after 12 weeks and 24 weeks

  • Change in PPG (postprandial control)

    after 12 weeks and 24 weeks

  • Change in insulin dose and number of injections

    after 12 weeks and 24 weeks

  • Change in oral antidiabetic drug therapy

    after 12 weeks and 24 weeks

  • +3 more secondary outcomes

Study Arms (3)

A

Drug: insulin aspart

B

Drug: biphasic insulin aspart 30

C

Drug: insulin detemir

Interventions

insulin aspartDRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Also known as: NovoRapid®
A
biphasic insulin aspart 30DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

B
insulin detemirDRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

C

Eligibility Criteria

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

Diabetes type 2

You may qualify if:

  • Patients with type 2 diabetes
  • Patients treated with human soluble insulin, NPH insulin or premixed human insulin
  • Patients willing to sign informed consent
  • Selection of study participants at the discretion of the physician

You may not qualify if:

  • Subjects currently being treated with insulin aspart, insulin detemir or biphasic insulin aspart 30
  • Subjects who were previously enrolled in this study
  • Subjects with a hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Bratislava, 811 05, Slovakia

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin Aspartinsulin aspart, insulin aspart protamine drug combination 30:70Insulin Detemir

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

May 9, 2008

First Posted

May 13, 2008

Study Start

February 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

SL(1)