Observational Study on the Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or Combined) in Type 2 Diabetics Previously Treated With Anti-diabetic Medication (A1chieve®)

January 18, 2017 updated by: Novo Nordisk A/S

The Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or in Combination) in Subjects With Type 2 Diabetes Previously Treated With Other Anti-diabetic Medication. A 24-week, International, Prospective, Multi-centre, Open-labelled, Non-interventional Study

This study is conducted in Africa, Asia, South America and Europe. The aim of this observational study is to document the experience with the study insulins when used in routine clinical practice. After the physician's decision to start insulin treatment using NovoMix® 30, Levemir® or NovoRapid® (alone or combined), type 2 diabetics will be eligible to be included in this study at the physician's discretion

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

66726

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

  • Algeria
      • Algiers, Algeria, 16035
        • Novo Nordisk Investigational Site
  • Argentina
      • Prov. de Buenos Aires, Argentina, B1636DSU
        • Novo Nordisk Investigational Site
  • Bangladesh
      • Dhaka, Bangladesh, 1206
        • Novo Nordisk Investigational Site
  • China
    • Beijing
      • Beijing, Beijing, China, 100004
        • Novo Nordisk Investigational Site
  • Egypt
      • Cairo, Egypt
        • Novo Nordisk Investigational Site
  • India
      • Bangalore, India, 560001
        • Novo Nordisk Investigational Site
  • Indonesia
      • Jakarta, Indonesia, 12520
        • Novo Nordisk Investigational Site
  • Iran, Islamic Republic of
      • Teheran, Iran, Islamic Republic of
        • Novo Nordisk Investigational Site
  • Jordan
      • Amman, Jordan, 11844
        • Novo Nordisk Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 137-920
        • Novo Nordisk Investigational Site
  • Libyan Arab Jamahiriya
      • Tripoli, Libyan Arab Jamahiriya
        • Novo Nordisk Investigational Site
  • Malaysia
      • Selangor Darul Ehsan, Malaysia
        • Novo Nordisk Investigational Site
  • Mexico
      • Mexico City, Mexico
        • Novo Nordisk Investigational Site
  • Morocco
      • Casablanca, Morocco, 20000
        • Novo Nordisk Investigational Site
  • Pakistan
      • Karachi, Pakistan
        • Novo Nordisk Investigational Site
  • Philippines
      • Manilla, Philippines, 1605
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 119330
        • Novo Nordisk Investigational Site
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 3542
        • Novo Nordisk Investigational Site
  • Singapore
      • Singapore, Singapore, 307684
        • Novo Nordisk Investigational Site
  • Taiwan
      • Taipei, Taiwan
        • Novo Nordisk Investigational Site
  • Tunisia
      • Tunisia, Tunisia, 1053
        • Novo Nordisk Investigational Site
  • Turkey
      • Istanbul, Turkey, 34335
        • 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

Only people with type 2 diabetes treated by general practitioners and specialists who prescribe insulin analogues in their routine practice will be included

Description

Inclusion Criteria:

  • After the physician has taken the decision to use NovoMix®30, Levemir® or NovoRapid® (alone or combined), any subject with type 2 diabetes who is not treated with these insulins or who has started on these insulin within the last 4 weeks before inclusion into this study is eligible for the study.
  • The selection of the subjects will be at the discretion of the individual physician.

Exclusion Criteria:

  • Subjects treated with NovoMix® 30, Levemir® or NovoRapid® (alone or in combination) for more than 4 weeks before inclusion into this study.
  • Subjects who were previously enrolled in this study.
  • Subjects with a hypersensitivity to NovoMix® 30, Levemir® or NovoRapid® or to any of the excipients.
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 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: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Drug: insulin aspart
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Names:
  • NovoRapid®
  • ANA
Drug: biphasic insulin aspart
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of serious adverse drug reactions and major hypoglycaemic events reported as serious adverse drug reactions
Time Frame: at baseline, 12 weeks and 24 weeks
at baseline, 12 weeks and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the prescribing patterns and choice of insulin analogues in routine clinical practice
Time Frame: at baseline, 12 weeks and 24 weeks
at baseline, 12 weeks and 24 weeks
Change in number of hypoglycaemic events
Time Frame: at baseline, 12 weeks and 24 weeks
at baseline, 12 weeks and 24 weeks
Change in HbA1c
Time Frame: at baseline, 12 weeks and 24 weeks
at baseline, 12 weeks and 24 weeks
Change in FPG (Fasting Plasma Glucose)
Time Frame: at baseline, 12 weeks and 24 weeks
at baseline, 12 weeks and 24 weeks
Change in PPG (postprandial glucose)
Time Frame: at baseline, 12 weeks and 24 weeks
at baseline, 12 weeks and 24 weeks

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

November 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

March 25, 2009

First Posted (Estimate)

March 26, 2009

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS-3693

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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