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NCT01542424 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01542424
Other study ID # NN304-1763
Secondary ID
Status Completed
Phase N/A
First received February 24, 2012
Last updated January 30, 2017
Start date March 2006
Est. completion date December 2006

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1889
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart 30
Prescribed at the discretion of the physician
• insulin detemir
Prescribed at the discretion of the physician

Locations
Country Name City State
Macedonia, The Former Yugoslav Republic of Novo Nordisk Investigational Site Skopje

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Macedonia, The Former Yugoslav Republic of, 

References & Publications (1)

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 Clini

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c (glycosylated haemoglobin)
Secondary Percentage of subjects reaching HbA1c target of maximum 7.0%
Secondary Postprandial plasma glucose (PPG)
Secondary Fasting plasma glucose (FPG)
Secondary Change in body weight
Secondary Incidence of adverse events
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