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NCT00698126 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— UPGRADE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00698126
Other study ID # ANA-1897
Secondary ID
Status Completed
Phase N/A
First received June 13, 2008
Last updated October 26, 2016
Start date October 2007
Est. completion date May 2009

Study information
Verified date October 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 4099
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• soluble human insulin
Observational study; use of the products as in the normal clinical practice conditions
• biphasic insulin aspart
Observational study; use of the products as in the normal clinical practice conditions

Locations
Country Name City State
Italy Novo Nordisk Investigational Site Rome

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of major hypoglycaemic events reported as serious adverse drug reactions after 26 weeks Yes
Secondary Number of serious and non serious drug reactions during 26 weeks Yes
Secondary Number of serious adverse event during 26 weeks Yes
Secondary Number of all major (daytime and nocturnal) hypoglycaemic events during 26 weeks Yes
Secondary Number of major hypoglycaemic events related to omission of a meal after injection during 26 weeks Yes
Secondary Number of major hypoglycaemic events related to physical exercise of at least 30 min duration during 26 weeks Yes
Secondary Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks preceding each study visit after 26 weeks Yes
Secondary Weight and waist circumference change during 26 weeks No
Secondary Number of hypoglycaemia events in the two different treatment groups based on the HbA1c level after 26 weeks Yes
Secondary Quality of Life (QoL) after 26 weeks No
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