NCT01542463

Brief Summary

This study conducted in Europe. The aim of this study is to evaluated the use of insulin detemir (Levemir®) in insufficiently controlled patients with type 1 or type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,464

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2004

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

September 1, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

2.8 years

First QC Date

February 24, 2012

Last Update Submit

March 2, 2016

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • HbA1c (glycaemic haemoglobin)

  • Fasting plasma glucose (FBG)

Secondary Outcomes (4)

  • Body weight change

  • Adverse drug reactions (ADR)

  • Serious adverse drug reactions (SADR)

  • Hypoglycaemic episodes

Study Arms (1)

IDet users

Drug: insulin detemir

Interventions

insulin detemirDRUG

Prescribed at the discretion of the physician

IDet users

Eligibility Criteria

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

Patients with insufficiently controlled type 1 or type 2 diabetes mellitus under their previous therapy

You may qualify if:

  • Patients with insufficiently controlled type 1 or type 2 diabetes mellitus under their previous therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Mainz, 55127, Germany

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune 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
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2012

First Posted

March 2, 2012

Study Start

September 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

DE(1)