An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment

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

Efficacy and Safety Study in Subjects Using Levemir® (Insulin Detemir), NovoMix®30 (Biphasic Insulin Aspart 30) and/or NovoRapid® (Insulin Aspart) for the Treatment of Type 1 or Type 2 Diabetes Mellitus

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5926

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

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 3542
        • 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

Probability Sample

Study Population

A non-randomized sample of Type 1 or Type 2 diabetics

Description

Inclusion Criteria:

  • Type 1 or type 2 diabetes
  • Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid®
  • Selection will be at the discretion of the individual physician

Exclusion Criteria:

  • Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid®
  • Previous enrolled in this study
  • Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within 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

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
Other Names:
  • Levemir®
B
Drug: biphasic insulin aspart 30
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
C
Drug: 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
Incidence of major hypoglycaemic events reported
Time Frame: during 24 weeks of treatment
during 24 weeks of treatment
Change in HbA1c
Time Frame: during 24 weeks of treatment
during 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects achieving HbA1c below 7.0%
Time Frame: at 12 & 24 weeks
at 12 & 24 weeks
Change in FPG
Time Frame: at 12 & 24 weeks
at 12 & 24 weeks
Change in PPG
Time Frame: at 12 & 24 weeks
at 12 & 24 weeks
Body weight
Time Frame: at 12 & 24 weeks
at 12 & 24 weeks
Change in number of hypoglycaemic events in the last 4 weeks before routine visits
Time Frame: at 12 & 24 weeks
at 12 & 24 weeks
Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits
Time Frame: at 12 & 24 weeks
at 12 & 24 weeks
Number of adverse drug reactions (ADR)
Time Frame: at 12 & 24 weeks
at 12 & 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.

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

February 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 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 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-3532

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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