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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01542424
First received: February 24, 2012
Last updated: February 18, 2016
Last verified: February 2016

February 24, 2012
February 18, 2016
March 2006
December 2006   (final data collection date for primary outcome measure)
HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01542424 on ClinicalTrials.gov Archive Site
  • Percentage of subjects reaching HbA1c target of maximum 7.0% [ Designated as safety issue: No ]
  • Postprandial plasma glucose (PPG) [ Designated as safety issue: No ]
  • Fasting plasma glucose (FPG) [ Designated as safety issue: No ]
  • Change in body weight [ Designated as safety issue: No ]
  • Incidence of adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Macedonian people with diabetes mellitus (Type 1 or Type 2)
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Drug: biphasic insulin aspart 30
    Prescribed at the discretion of the physician
  • Drug: insulin detemir
    Prescribed at the discretion of the physician
  • BIAsp 30 users
    Intervention: Drug: biphasic insulin aspart 30
  • IDet users
    Intervention: Drug: insulin detemir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1889
December 2006
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Macedonian people with diabetes mellitus (Type 1 or Type 2)
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Macedonia, The Former Yugoslav Republic of
 
NCT01542424
NN304-1763
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP