Observational Study of Patients Using NovoRapid® or Soluble Human Insulin for Treatment of Type 2 Diabetes
UPGRADE
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
1 other identifier
observational
4,099
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 13, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedOctober 28, 2016
October 1, 2016
1.6 years
June 13, 2008
October 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of major hypoglycaemic events reported as serious adverse drug reactions
after 26 weeks
Secondary Outcomes (9)
Number of serious and non serious drug reactions
during 26 weeks
Number of serious adverse event
during 26 weeks
Number of all major (daytime and nocturnal) hypoglycaemic events
during 26 weeks
Number of major hypoglycaemic events related to omission of a meal after injection
during 26 weeks
Number of major hypoglycaemic events related to physical exercise of at least 30 min duration
during 26 weeks
- +4 more secondary outcomes
Study Arms (2)
A
B
Interventions
Observational study; use of the products as in the normal clinical practice conditions
Observational study; use of the products as in the normal clinical practice conditions
Eligibility Criteria
Any subject with type 2 diabetes who is already in treatment with insulin aspart or soluble human insulin will be included in the study
You may qualify if:
- Patients with type 2 diabetes
- Treatment with Insulin Aspart (NovoRapid®) or Soluble Human Insulin for minimum 3 months and maximum 3 years
You may not qualify if:
- Patients with an end-stage renal failure
- Patients with a serious liver disease
- Patients with concomitant malignant disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Rome, 00144, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2008
First Posted
June 17, 2008
Study Start
October 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
October 28, 2016
Record last verified: 2016-10