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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:
ClinicalTrials.gov Identifier:
NCT01542424
First Posted: March 2, 2012
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
February 24, 2012
March 2, 2012
January 31, 2017
March 2006
December 2006   (Final data collection date for primary outcome measure)
HbA1c (glycosylated haemoglobin)
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%
  • Postprandial plasma glucose (PPG)
  • Fasting plasma glucose (FPG)
  • Change in body weight
  • Incidence of adverse events
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
Dimitrovski, Cedomir and Smokovski, Ivica and Makrevska, Snezana and Mileva, Iskira and Kostojcinoska, Mira (2009) Significant Improvements in Glycaemic Control without Weight Gain with Insulin Detemir in Clinical Reality: Experience from Macedonian Clinical Practice. In: ADA Congress 2009, 05-09 June 2009, New Orleans, USA.

*   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)
Sexes Eligible for Study: All
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
January 2017