An Observational Study to Compare the Safety and Effectiveness of NovoMix® 30 and Levemir™ for the Treatment of Diabetes (SAFE)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT00789711

First received: November 10, 2008

Last updated: June 15, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 10, 2008

Last Updated Date

June 15, 2012

Start Date ^ICMJE

November 2008

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions. [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00789711 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

HbA1c [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
FBG (Fasting Blood Glucose) [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Average (mean) fasting plasma glucose level [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Number of minor (including nocturnal) hypoglycaemic events [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: Yes ]
Number of major (including nocturnal) hypoglycaemic events [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: Yes ]

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

An Observational Study to Compare the Safety and Effectiveness of NovoMix® 30 and Levemir™ for the Treatment of Diabetes

Official Title ^ICMJE

A Multicentre, Open-label, Nonrandomised, Non-interventional, Observational Study to Compare Safety and Effectiveness of Biphasic Insulin Aspart 30 (NovoMix 30) and Insulin Detemir (Levemir) for the Treatment of Diabetes Mellitus

Brief Summary

This study is conducted in Asia. The aim of this observational study is to compare the clinical safety profile and effectiveness of NovoMix® 30 and Levemir™ for the treatment of diabetes in the Philippines.

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

Any subject with diabetes mellitus who needs insulin treatment at the time of inclusion is eligible for the study, including newly diagnosed subjects who have never received insulin or an insulin analogue before

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: biphasic insulin aspart 30
Evaluation of the safety profile and effectiveness of biphasic insulin aspart 30 in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines
Other Names:
- NovoMix® 30
- BIASP
Drug: insulin detemir
Evaluation of the safety profile and effectiveness of insulin detemir in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines

Study Group/Cohort (s)

A
Intervention: Drug: biphasic insulin aspart 30
B
Intervention: Drug: insulin detemir

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

2589

Completion Date

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients diagnosed with type 1 or type 2 diabetes mellitus
Patients uncontrolled on oral antidiabetic drugs
Insulin naïve patients or patients currently on human insulin

Exclusion Criteria:

Subjects who are unlikely to comply with protocol requirements
Subjects who are previously enrolled in NovoMix® 30 and Levemir™ study
Subjects on NovoMix® 30 and Levemir™ therapy
Subjects with hypersensitivity to NovoMix® 30 or to any of the excipients
Subjects with hypersensitivity to Levemir™ or to any of the excipients
Females of child bearing potential who are pregnant, breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures are required by local law or practice
Contraindications and warnings specified in the current prescribing information

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Philippines

Administrative Information

NCT Number ^ICMJE

NCT00789711

Other Study ID Numbers ^ICMJE

BIASP-3682

Has Data Monitoring Committee

Responsible Party

Novo Nordisk

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Love Taganas, BSc Pharm

Novo Nordisk Pharmaceuticals (Philippines), Inc.

Information Provided By

Novo Nordisk

Verification Date

June 2012

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

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