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

This study has been completed.
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: June 13, 2008
Last updated: August 8, 2014
Last verified: August 2014
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.

Condition Intervention
Diabetes Mellitus, Type 2
Drug: soluble human insulin
Drug: biphasic insulin aspart

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number of major hypoglycaemic events reported as serious adverse drug reactions [ Time Frame: after 26 weeks ] [ Designated as safety issue: Yes ]

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

Enrollment: 4099
Study Start Date: October 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: soluble human insulin
Observational study; use of the products as in the normal clinical practice conditions
Other Name: Actrapid
B Drug: biphasic insulin aspart
Observational study; use of the products as in the normal clinical practice conditions


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698126

Rome, Italy, 00144
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Annamaria Matera Novo Nordisk Farmaceutici SpA
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00698126     History of Changes
Other Study ID Numbers: ANA-1897 
Study First Received: June 13, 2008
Last Updated: August 8, 2014
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 03, 2016