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NCT01536639 Clinical Trial

Physiological Concept of Insulin Therapy in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Physiological Concept of Insulin Therapy in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01536639
Other study ID # BIASP-1929
Secondary ID
Status Completed
Phase N/A
First received February 16, 2012
Last updated January 6, 2017
Start date January 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 Slovakia: State Institute for Drug Control
Study type Observational

Clinical Trial Summary

This study is conducted in Europe. The aim of the study was to evaluate the safety and efficacy of biphasic insulin aspart 30 (NovoMix® 30) when switching to a modern premix insulin analogue treatment compared to previous insulin regimen in routine clinical practice in the Slovak Republic.

Recruitment information / eligibility
Status Completed
Enrollment 454
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:

- Subjects with type 2 diabetes

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart 30
Administered by subcutaneous injection. The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any

Locations
Country Name City State
Slovakia Novo Nordisk Investigational Site Bratislava

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

Country where clinical trial is conducted

Slovakia, 

References & Publications (1)

Significant reduction in proportion of T2 diabetes patients at high risk for developing late complications after switching human insulin to BIAsp 30; results of an observational study in Slovakia; Z. Schroner; 2085-PO; 69th American Diabetes Association,

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c (glycosylated haemoglobin) No
Secondary Fasting plasma glucose (FPG) No
Secondary Post-prandial glucose (PPG) No
Secondary Weight No
Secondary Hypoglycaemia No
Secondary Adverse events No
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