Observational Study of Safety of NovoMix® 30 Treatment for Type 2 Diabetes (Start)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01486875

First received: December 5, 2011

Last updated: NA

Last verified: December 2011

History: No changes posted

Tracking Information

First Received Date ^ICMJE

December 5, 2011

Last Updated Date

December 5, 2011

Start Date ^ICMJE

January 2006

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of serious adverse drug reactions (SADRs) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Incidence of major hypoglycaemic events [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Number of all hypoglycaemic events [ Time Frame: In the 4 weeks prior to week 12 and week 26, respectively ] [ Designated as safety issue: No ]
HbA1c (glycosylated haemoglobin A1c) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Fasting Plasma Glucose (FPG) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Observational Study of Safety of NovoMix® 30 Treatment for Type 2 Diabetes

Official Title ^ICMJE

NovoMix® Start - A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix 30® Treatment

Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

After the physician has decided to initiate biphasic insulin aspart 30 therapy, any insulin-naïve patient with type 2 diabetes mellitus in need of improved metabolic control, as judged by the treating physician, will be able to participate

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: biphasic insulin aspart 30

Dose individually adjusted, and administered subcutaneously (under the skin) once or twice daily

Study Group/Cohort (s)

BIAsp 30

Intervention: Drug: biphasic insulin aspart 30

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1155

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects with type 2 diabetes

Gender

Both

Ages

18 Years to 68 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT01486875

Other Study ID Numbers ^ICMJE

BIASP-1721

Has Data Monitoring Committee

Responsible Party

Novo Nordisk

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Kerstin Magnusson

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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