Skip to main content
OpenTrials
Completed

NCT Number: NCT00698126

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Rome, 00144, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

soluble human insulin

Drug

Observational study; use of the products as in the normal clinical practice conditions

Other names: Actrapid

biphasic insulin aspart

Drug

Observational study; use of the products as in the normal clinical practice conditions

Primary outcomes

  1. Number of major hypoglycaemic events reported as serious adverse drug reactions

    Time frame: after 26 weeks

Secondary outcomes

  1. Number of serious and non serious drug reactions

    Time frame: during 26 weeks

  2. Number of serious adverse event

    Time frame: during 26 weeks

  3. Number of all major (daytime and nocturnal) hypoglycaemic events

    Time frame: during 26 weeks

  4. Number of major hypoglycaemic events related to omission of a meal after injection

    Time frame: during 26 weeks

  5. Number of major hypoglycaemic events related to physical exercise of at least 30 min duration

    Time frame: during 26 weeks

  6. Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks preceding each study visit

    Time frame: after 26 weeks

  7. Weight and waist circumference change

    Time frame: during 26 weeks

  8. Number of hypoglycaemia events in the two different treatment groups based on the HbA1c level

    Time frame: after 26 weeks

  9. Quality of Life (QoL)

    Time frame: after 26 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: UPGRADE

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 17, 2008
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.