Observational Study to Evaluate the Effectiveness and Safety of Levemir®, NovoMix® 30 and NovoRapid® in Insulin naïve Subjects With Type 2 Diabetes

October 26, 2016 updated by: Novo Nordisk A/S

Evaluation of Effectiveness and Safety of Levemir® (Insulin Detemir), NovoMix® (Biphasic Insulin Aspart) and/or NovoRapid® (Insulin Aspart) in Insulin naïve Subjects With Type 2 Diabetes.

This study is conducted in Europe and Asia. The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used insulin previously under normal clinical practice conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10408

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

  • Russian Federation
      • Moscow, Russian Federation, 119330
        • Novo Nordisk Investigational Site
  • Ukraine
      • Kiev, Ukraine, 252030
        • 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

Patients of both genders who, in practice settings, have been deemed appropriate to receive Levemir®, NovoMix® 30 or and/or NovoRapid® as new treatment and as part of routine out-patient care by the prescribing physician.

Description

Inclusion Criteria:

  • Any insulin näive type 2 diabetic patient that able to use the drug as judged by the investigator

Exclusion Criteria:

  • In accordance with approved label

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: insulin detemir
Start dose and frequency at the discretion of the physician following clinical practice
Drug: biphasic insulin aspart 30
Start dose and frequency at the discretion of the physician following clinical practice
Drug: insulin aspart
Start dose and frequency at the discretion of the physician following clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: at baseline visit and during 3, 6, 9 and 12 months
at baseline visit and during 3, 6, 9 and 12 months
Serious adverse drug reactions including major hypoglycaemic events
Time Frame: during 12 months of treatment
during 12 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of serious adverse drug reactions
Time Frame: during 12 months of treatment
during 12 months of treatment
Number of all major (daytime and nocturnal) hypoglycaemic events
Time Frame: during 12 months of treatment
during 12 months of treatment
Number of all minor (daytime and nocturnal) hypoglycaemic events
Time Frame: During 4 weeks prior to each study visit
During 4 weeks prior to each study visit
Weight (BMI) change
Time Frame: At 6 and 12 months
At 6 and 12 months
Variability in fasting blood glucose values and average (mean) fasting blood glucose level
Time Frame: At baseline visit and after 6 and 12 months treatment
At baseline visit and after 6 and 12 months treatment
Average post-prandial blood glucose level (2h after dinner)
Time Frame: At baseline visit and after 6 and 12 months treatment
At baseline visit and after 6 and 12 months treatment
Quality of Life (QoL) as assessed by patient questionnaire
Time Frame: At baseline and the end of 6 and 12 months treatment
At baseline and the end of 6 and 12 months 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

October 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 9, 2008

First Submitted That Met QC Criteria

October 10, 2008

First Posted (Estimate)

October 13, 2008

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS-3655

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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