Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®

March 4, 2016 updated by: Novo Nordisk A/S

An Observational Study Evaluating the Safety and Efficacy of the Treatment With Biphasic Insulin Aspart (NovoMix® 30 FlexPen®) in the Treatment of Type 2 Diabetics After Failing on Basal/ Intermediate Mono or Combination Therapy

This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

216

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

Probability Sample

Study Population

Type 2 diabetic patients

Description

Inclusion Criteria:

  • Type 2 diabetes having failed on basal insulin with or without OAD
  • HbA1c greater than 7.0%

Exclusion Criteria:

  • Subjects being unlikely to comply with protocol requirements
  • Subjects who previously enrolled in this study
  • Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients
  • Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method

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
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Names:
  • NovoMix® 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of major hypoglycaemic events reported as serious adverse drug reactions
Time Frame: during 26 weeks of treatment
during 26 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of serious adverse drug reactions
Time Frame: during 26 weeks of treatment
during 26 weeks of treatment
Number of serious adverse events
Time Frame: during 26 weeks of treatment
during 26 weeks of treatment
Number of all major (daytime and nocturnal) hypoglycaemic events
Time Frame: during 26 weeks of treatment
during 26 weeks of treatment
Number of all minor (daytime and nocturnal) hypoglycaemic events
Time Frame: during 26 weeks of treatment
during 26 weeks of treatment
Weight (BMI) change from baseline
Time Frame: At the end of the study
At the end of the study
HbA1c change from baseline
Time Frame: At the end of the study
At the end of the study
Percentage of patients reaching the target of HbA1c of less than or equal to 7.0%
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
Average post-breakfast (90-120 mins), post-lunch (90-120 mins), post-dinner (90-120 mins) plasma glucose level
Time Frame: At the end of the study
At the end of the study

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

May 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

July 1, 2008

First Submitted That Met QC Criteria

July 1, 2008

First Posted (Estimate)

July 3, 2008

Study Record Updates

Last Update Posted (Estimate)

March 7, 2016

Last Update Submitted That Met QC Criteria

March 4, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-3572

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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