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NCT01548235 Clinical Trial

Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting or Switching to Biphasic Insulin Aspart 30 Treatment

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus, Starting or Switching to NovoMix® 30 Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01548235
Other study ID # BIASP-1812
Secondary ID
Status Completed
Phase N/A
First received March 5, 2012
Last updated January 5, 2017
Start date February 2006
Est. completion date April 2007

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

Clinical Trial Summary

This study is conducted in Europe. The aim of this study is to investigate safety and efficacy in subjects with type 2 diabetes mellitus starting or switching to biphasic insulin aspart 30 (NovoMix® 30) treatment.

Recruitment information / eligibility
Status Completed
Enrollment 423
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Subjects with type 2 diabetes

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart 30
Prescribed biphasic insulin aspart 30 as part of routine care. Starting dose, dose titration and injection frequency determined individually by each physician.

Locations
Country Name City State
Denmark Novo Nordisk Investigational Site Copenhagen S

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

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Breum L, Almdal T, Eiken P, Lund P, Christiansen E; Danish BIAsp Study Group.. Initiating or switching to biphasic insulin aspart 30/70 therapy in subjects with type 2 diabetes mellitus. An observational study. Rev Diabet Stud. 2008 Fall;5(3):154-62. doi: — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of SADR (serious adverse drug reactions) including major hypoglycaemia No
Secondary Change from baseline in HbA1c (glycosylated haemoglobin) No
Secondary Mean FPG (fasting plasma glucose) No
Secondary Overall, daytime and nocturnal frequency of hypoglycaemic events No
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