Observational Study of Patients Using NovoRapid® or Soluble Human Insulin for Treatment of Type 2 Diabetes (UPGRADE)

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

A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Subjects Using Insulin Aspart (NovoRapid® ) or Soluble Human Insulin for the Treatment of Diabetes Mellitus the UPGRADE Study

This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4099

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

  • Italy
      • Rome, Italy, 00144
        • 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

Any subject with type 2 diabetes who is already in treatment with insulin aspart or soluble human insulin will be included in the study

Description

Inclusion Criteria:

  • Patients with type 2 diabetes
  • Treatment with Insulin Aspart (NovoRapid®) or Soluble Human Insulin for minimum 3 months and maximum 3 years

Exclusion Criteria:

  • Patients with an end-stage renal failure
  • Patients with a serious liver disease
  • Patients with concomitant malignant disease

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

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: soluble human insulin
Observational study; use of the products as in the normal clinical practice conditions
Other Names:
  • Actrapid
B
Drug: biphasic insulin aspart
Observational study; use of the products as in the normal clinical practice conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of major hypoglycaemic events reported as serious adverse drug reactions
Time Frame: after 26 weeks
after 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of serious and non serious drug reactions
Time Frame: during 26 weeks
during 26 weeks
Number of serious adverse event
Time Frame: during 26 weeks
during 26 weeks
Number of all major (daytime and nocturnal) hypoglycaemic events
Time Frame: during 26 weeks
during 26 weeks
Number of major hypoglycaemic events related to omission of a meal after injection
Time Frame: during 26 weeks
during 26 weeks
Number of major hypoglycaemic events related to physical exercise of at least 30 min duration
Time Frame: during 26 weeks
during 26 weeks
Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks preceding each study visit
Time Frame: after 26 weeks
after 26 weeks
Weight and waist circumference change
Time Frame: during 26 weeks
during 26 weeks
Number of hypoglycaemia events in the two different treatment groups based on the HbA1c level
Time Frame: after 26 weeks
after 26 weeks
Quality of Life (QoL)
Time Frame: after 26 weeks
after 26 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

October 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 13, 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

  • ANA-1897

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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