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CompletedNCT00665093Updated Jan 9, 2017

Observational Study of Patients Using NovoMix® 30 or Levemir® for Treatment of 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 Macedonia, The Former Yugoslav Republic of. Per ClinicalTrials.gov, last updated 2017-01-09.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,569
Sex
All
01

Study summary

This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.

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 1,569 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

Type 1 and Type 2 diabetes mellitus

Inclusion criteria

  • Levemir® above 6 yrs
  • NovoMix® 30 above 18 yrs
  • Patients with Type 1 or Type 2 diabetes, including newly diagnosed

Exclusion criteria

Exclusion Criteria:

  • Current treatment with NovoMix® 30 or Levemir®
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,569 participants (actual)
Patient registry
No

Groups and cohorts

  • A

    Drug: biphasic insulin aspart 30

  • B

    Drug: insulin detemir

Interventions

  • Drugbiphasic insulin aspart 30

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

    Also known as: NovoMix® 30, BIASP

  • Druginsulin detemir

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

06

What researchers measure

Primary outcomes

  1. HbA1c

    Time frame: at 24 weeks

Secondary outcomes

  1. FPG, PG profile, weight, % of subjects on target

    Time frame: at 24 weeks

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Skopje, MK-1000, Macedonia, The Former Yugoslav Republic of
08

References and documents

Publications

  • Milenkovic T. Significant Improvements in Glycemic Control with BIAsp 30 in Clinical Reality: Experience from clinical practice in Macedonia. ADA American Diabetes Association 2009; Country: USA City: New Orleans
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00665093
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Apr 23, 2008
Start date
May 2007
Primary completion
Jan 2008
Completion
Jan 2008
Last update
Jan 9, 2017

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 Jan 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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