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NCT00704223 Clinical Trial

Observational Study to Evaluate the Safety and Efficacy of NovoMix® 70 in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— INTENSIV  

Official title:
Observational Study on Safety and Efficacy in Subjects Using NovoMix® 70 (Biphasic Insulin Aspart) for Treatment of Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00704223
Other study ID # BIASP-3576
Secondary ID
Status Completed
Phase N/A
First received June 20, 2008
Last updated June 23, 2014
Start date May 2008
Est. completion date November 2008

Study information
Verified date June 2014
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Austria: Not required for observational study in Austria
Study type Observational

Clinical Trial Summary

This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 70 under normal clinical practice conditions in Austria.

Recruitment information / eligibility
Status Completed
Enrollment 619
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Type 2 diabetes

- HbA1c over 7%

- No contraindication with NovoMix® 70

Exclusion Criteria:

- Type 1 diabetes

- Subjects participating in a clinical trial or another observational study

- Subjects under previous basis-bolus insulin therapy

- Women who are pregnant, breast feeding and women of child bearing capacity who are not using any reliable contraceptive method

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart
Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation

Locations
Country Name City State
n/a

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

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of major and minor hypoglycaemic events and adverse events 3 months Yes
Secondary HbA1c 3 months No
Secondary PPBG 3 months No
Secondary FBG 3 months No
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