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CompletedNCT00697450Updated Nov 23, 2016

Observational Study on the Weight Effect of Insulin Detemir (Levemir®) in Type 2 Diabetics

An observational study in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Czech Republic. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-23.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
206
Ages
18 Years and older
Sex
All
01

Study summary

This study is conducted in Europe. Observational study evaluating the body weight progress during the treatment with insulin detemir (Levemir®) in Type 2 patients, previously treated with other basal insulins

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 206 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Type 2 diabetics

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Current treatment with insulin detemir
  • Previous enrolment in this study
  • Hypersensitivity to insulin detemir or to any of the excipients.
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
206 participants (actual)
Patient registry
No

Groups and cohorts

  • All participants

    Drug: insulin detemir

Interventions

  • Druginsulin detemir

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

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What researchers measure

Primary outcomes

  1. Weight effect

    Time frame: 12 months prior to and 12 months after detemir treatment.

Secondary outcomes

  1. Improvement in FPG levels

    Time frame: 12 months prior and 12 months after detemir treatment

  2. Improvement in HbA1c levels

    Time frame: 12 months prior and 12 months after detemir treatment

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Prague, 16000, Czech Republic
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00697450
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jun 13, 2008
Start date
Jul 2008
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Nov 23, 2016

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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