Efficacy and Safety of Biphasic Insulin Aspart 30 for the Treatment of Type 2 Diabetes Mellitus

April 11, 2012 updated by: Novo Nordisk A/S

A Clinical Experience Programme to Collect Data on the Safety and Efficacy of NovoMix® 30 in the Treatment of Patients With Type 2 Diabetes in Jordan

This study is conducted in Asia. The aim of this observational study is to collect efficacy and safety data of biphasic insulin aspart (NovoMix® 30) in type 2 diabetes under normal clinical practice conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

298

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

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

Patients from hospitals or clinics diagnosed with type 2 diabetes mellitus

Description

Inclusion Criteria:

  • Subjects from hospitals or clinics, diagnosed with type 2 diabetes mellitus

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
BIAsp 30 users
Drug: biphasic insulin aspart 30
Administered via an insulin injection device. Dosages varied according to individual patients' medical requirement as determined by their attending clinician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures

Outcome Measure
Incidence of adverse events
Incidence of hypoglycaemic episodes
FBG (Fasting Blood Glucose)
Quality of life assessed through the WHO-DTSQ (World Health Organization-Diabetes Treatment Satisfaction Questionnaire)

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Corporate Vice President for diabetes and devices, 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

January 1, 2004

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

February 15, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (Estimate)

March 1, 2012

Study Record Updates

Last Update Posted (Estimate)

April 12, 2012

Last Update Submitted That Met QC Criteria

April 11, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1892

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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