NCT00715351

Brief Summary

This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes with Levemir® compared to Insulatard® under normal clinical practice conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
342

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

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

May 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

July 11, 2008

Last Update Submit

November 23, 2016

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Body weight change

    at 3 months and 6 months after baseline

Secondary Outcomes (9)

  • Hypoglycemic events

    at 3 months and 6 months after baseline

  • Changes in glycaemic parameters

    at 3 months and 6 months after baseline

  • Safety parameters by collecting (serious) adverse events and the pregnancies.

    at 3 months and 6 months after baseline

  • Evaluation of general well-being by using the WHO-5 well-being questionnaire (Appendix I).

    at 3 months and 6 months after baseline

  • Treatment satisfaction of subjects treated with insulin Levemir or NPH insulin by using insulin satisfaction ('Tevredenheid met insuline behandeling': Appendix II)

    at 3 months and 6 months after baseline

  • +4 more secondary outcomes

Study Arms (2)

A

Drug: insulin detemir

B

Drug: insulin NPH

Interventions

insulin detemirDRUG

Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician

A
insulin NPHDRUG

Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician

B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Insulin naïve patients with type 2 diabetes treated with oral antidiabetics

You may qualify if:

  • Type 2 diabetes failing on oral blood glucose lowering therapy, and requiring insulin therapy.

You may not qualify if:

  • Type 1 diabetes
  • Previous use of insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Ljubljana, SI-1000, Slovenia

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin DetemirInsulin, Isophane

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-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
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2008

First Posted

July 15, 2008

Study Start

May 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations

SL(1)