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

October 27, 2016 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3131

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Manilla, Philippines, 1605
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
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
B
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions.
Time Frame: during 12 months of treatment
during 12 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: at the end of the study
at the end of the study
FBG (Fasting Blood Glucose)
Time Frame: at the end of the study
at the end of the study
Average (mean) fasting plasma glucose level
Time Frame: at the end of the study
at the end of the study
Number of minor (including nocturnal) hypoglycaemic events
Time Frame: during 12 months of treatment
during 12 months of treatment
Number of major (including nocturnal) hypoglycaemic events
Time Frame: during 12 months of treatment
during 12 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

November 10, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-3682

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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