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CompletedNCT01542463Updated Mar 3, 2016

Evaluation of the Use of Levemir® in Insufficiently Controlled Patients With Type 1 or Type 2 Diabetes

An observational study in Diabetes, Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2016-03-03.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,464
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 1
  • 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 4,464 is above 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
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

Inclusion Criteria:

  • Patients with insufficiently controlled type 1 or type 2 diabetes mellitus under their previous therapy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,464 participants (actual)
Patient registry
No

Groups and cohorts

  • IDet users

    Drug: insulin detemir

Interventions

  • Druginsulin detemir

    Prescribed at the discretion of the physician

06

What researchers measure

Primary outcomes

  1. HbA1c (glycaemic haemoglobin)

  2. Fasting plasma glucose (FBG)

Secondary outcomes

  1. Body weight change

  2. Adverse drug reactions (ADR)

  3. Serious adverse drug reactions (SADR)

  4. Hypoglycaemic episodes

07

Study locations

1 site
  • Mainz, 55127, Germany
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01542463
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Mar 2, 2012
Start date
Sep 2004
Primary completion
Jul 2007
Completion
Jul 2007
Last update
Mar 3, 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 Mar 2016. You cannot join it, but the record below documents what was studied.

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