Observational Study of Biphasic Insulin Aspart 30 Alone or in Combination With Oral Hypoglycaemic Agents in Subjects With Type 2 Diabetes (PRESENT)

January 5, 2017 updated by: Novo Nordisk A/S

A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix 30 as Monotherapy, or in Combination With OHAs, in the Treatment of Type 2 Diabetic Patients in Routine Clinical Practice

This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic agent (OHA) for type 2 diabetes management in routine clinical practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

33010

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with type 2 diabetes who were not adequately controlled on their current therapy and who were prescribed biphasic insulin aspart 30 (NovoMix® 30)

Description

Inclusion Criteria:

  • Subjects with type 2 diabetes whose glycaemia was not optimally controlled with current therapy

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
The insulin dose and regimen was individualised at the physician's discretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures

Outcome Measure
Incidence of hypoglycaemic episodes
Adverse drug reactions (ADR)
Change in post prandial glucose (PPG)
Change in fasting glucose (FG)
Difference in prandial glucose increment (PGI)

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.

General Publications

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

September 1, 2004

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 21, 2012

First Posted (ESTIMATE)

February 22, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1880

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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Locations

3
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