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An Observational Study in Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes Mellitus

A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01542424
Enrollment
1889
Registered
2012-03-02
Start date
2006-03-31
Completion date
2006-12-31
Last updated
2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Brief summary

This trial is conducted in Europe. The aim of this trial is to investigate efficacy and safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects with type 1 or 2 diabetes mellitus.

Interventions

DRUGbiphasic insulin aspart 30

Prescribed at the discretion of the physician

DRUGinsulin detemir

Prescribed at the discretion of the physician

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Macedonian people with diabetes mellitus (Type 1 or Type 2)

Design outcomes

Primary

MeasureTime frame
HbA1c (glycosylated haemoglobin)

Secondary

MeasureTime frame
Percentage of subjects reaching HbA1c target of maximum 7.0%
Postprandial plasma glucose (PPG)
Fasting plasma glucose (FPG)
Change in body weight
Incidence of adverse events

Countries

North Macedonia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026