Observational Study to Evaluate the Efficacy and Safety of NovoMix® 30 in Type 1 and 2 Diabetes (EFFECTIVE)

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

EFFicacious glycaEmia Control, Treatment Goal achIevement Very simplE With NovoMix 30: A Single-country, Multicentre, Prospective, Open Label, Non-controlled, Observational, 26-week Study in Serbian Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Diabetes Mellitus in Everyday Clinical Practice

This study is conducted in Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical practice conditions in Serbia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2308

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 1 and 2 diabetes

Description

Inclusion Criteria:

  • Type 1 or Type 2 Diabetes Mellitus inadequately controlled on human insulin therapy lasting for at least 6 months
  • HbA1c greater than 7%
  • Informed Consent

Exclusion Criteria:

  • Patients with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
  • Other limiting conditions specified in the locally approved NovoMix 30 SPC ( Summary of Product Characteristics), PIL ( Patient Information Leaflet).
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next couple of months

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: biphasic insulin aspart 30
There is no intervention in this trial. The trial is prepared to be non-interventional one. Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation.
Other Names:
  • NovoMix® 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c from baseline
Time Frame: After 6 months
After 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients achieving HbA1c below 7,5% for Type 1 Diabetes Mellitus, below 7.0% and below or equal to 6.5% for Type 2 Diabetes Mellitus
Time Frame: after 12 weeks and 26 weeks compared to baseline
after 12 weeks and 26 weeks compared to baseline
Change in FPG (glucose variability)
Time Frame: after 12 weeks and 26 weeks compared to baseline
after 12 weeks and 26 weeks compared to baseline
Change in PPG (postprandial control)
Time Frame: after 12 weeks and 26 weeks compared to baseline
after 12 weeks and 26 weeks compared to baseline
Change in insulin dose and number of injections
Time Frame: at 12 weeks and 26 weeks of treatment
at 12 weeks and 26 weeks of treatment
Change in oral antidiabetic drug therapy dosage and eventual discontinuation of oral antidiabetic drug therapy during the study
Time Frame: after 12 weeks and 26 weeks of treatment compared to baseline
after 12 weeks and 26 weeks of treatment compared to baseline
Change in body weight and waist circumference
Time Frame: at 12 weeks and 26 weeks of treatment compared to baseline
at 12 weeks and 26 weeks of treatment compared to baseline
Change in number of major hypoglycaemic events during 4 weeks proceeding routine visits
Time Frame: at 12 weeks and 26 weeks of treatment compared to baseline
at 12 weeks and 26 weeks of treatment compared to baseline
Number of adverse drug reactions (ADR)
Time Frame: after 12 weeks and 26 weeks of treatment
after 12 weeks and 26 weeks 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

June 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (Estimate)

June 17, 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-3557

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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