NCT00706017

Brief Summary

This observational study is conducted in North America. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Shorter than P25 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, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2008

Completed
4 days 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
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

10 months

First QC Date

June 26, 2008

Last Update Submit

October 27, 2016

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Incidence of SADR (serious adverse drug reactions ) incl major hypo (hypoglycaemic events)

    during treatment

Secondary Outcomes (2)

  • Glucose control measures

    during treatment

  • Weight

    during treatment

Study Arms (1)

A

Drug: insulin detemir

Interventions

insulin detemirDRUG

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

Also known as: Levemir®
A

Eligibility Criteria

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

Patients from both general and speciality practice settings deemed appropraite to receive Levemir® as new treatment and as part of routine out-patient care by the prescribing physician

You may qualify if:

  • Type 1 or 2 diabetes
  • Including newly diagnosed not on insulin or insulin analogue treatment
  • Selection at the discretion of the physician
  • Adult patients with type 1 and 2 diabetes mellitus, and type 1 patients 6 years and older

You may not qualify if:

  • Current treatment with Levemir®
  • Previously enrolled in the study
  • Hypersensitivity to Levemir®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Mexico City, Mexico

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

June 26, 2008

First Posted

June 27, 2008

Study Start

September 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

ME(1)