Observational Study of Type 1 Diabetics Switching From Human Insulins to Modern Insulin Analogues

October 13, 2016 updated by: Novo Nordisk A/S

A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoRapid® (Insulin Aspart) and Levemir® (Insulin Detemir) in a Basal-bolus Regimen for Treatment of Type 1 Diabetes Mellitus in Romania

This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoRapid® (insulin aspart) and Levemir® (insulin detemir) after switch from human insulins for treatment of type 1 diabetes under normal clinical practice conditions in Romania.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

417

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

  • Romania
      • Bucharest, Romania, 010031
        • 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

Type 1 diabetes patients from diabetes centres who have been deemed appropriate to receive NovoRapid® and Levemir® as new treatment in basal-balus regimen and as part of routine care by the prescribing physician.

Description

Inclusion Criteria:

  • Any subject with type 1 diabetes who is treated with human rapid and intermediate (NPH) insulin in basal-bolus regimen

Exclusion Criteria:

  • Subjects currently being treated with insulin aspart and insulin detemir
  • Subjects who were previously enrolled in this study
  • Subjects with a hypersensitivity to insulin aspart or to any of the excipients
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients
  • Women who are pregnant 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: insulin aspart
Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice
Other Names:
  • NovoRapid®
  • ANA
Drug: insulin detemir
Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: at 24 weeks from baseline
at 24 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%
Time Frame: at 12 weeks and 24 weeks of treatment
at 12 weeks and 24 weeks of treatment
Change in FPG (glucose variability)
Time Frame: at 12 weeks and 24 weeks of treatment
at 12 weeks and 24 weeks of treatment
Change in PPG (postprandial control)
Time Frame: at 12 weeks and 24 weeks of treatment
at 12 weeks and 24 weeks of treatment
Change in insulin dose and number of injections
Time Frame: at 12 weeks and 24 weeks of treatment
at 12 weeks and 24 weeks of treatment
Change in body weight
Time Frame: at 12 weeks and 24 weeks of treatment
at 12 weeks and 24 weeks of treatment
Change in number of hypoglycaemic events
Time Frame: at 12 weeks and 24 weeks of treatment
at 12 weeks and 24 weeks of treatment
Number of adverse drug reactions (ADR)
Time Frame: at 12 weeks and 24 weeks of treatment
at 12 weeks and 24 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

April 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

March 31, 2009

First Submitted That Met QC Criteria

March 31, 2009

First Posted (Estimate)

April 1, 2009

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS-3721

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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