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

Novo Nordisk A/S1 site in 1 country4,099 target enrollmentOctober 2007

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionssoluble human insulin biphasic insulin aspart

Drugssoluble human insulin biphasic insulin aspart

Overview

Phase: Not Applicable
Intervention: soluble human insulin
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 4099
Locations: 1
Primary Endpoint: Number of major hypoglycaemic events reported as serious adverse drug reactions
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

May 2009

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

A

Intervention: soluble human insulin

B

Intervention: biphasic insulin aspart

Outcomes

Primary Outcomes

Number of major hypoglycaemic events reported as serious adverse drug reactions

Time Frame: after 26 weeks

Secondary Outcomes

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