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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00698126
First received: June 13, 2008
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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
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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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: 4143
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

  Eligibility

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

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

Locations
Italy
Rome, Italy, 00144
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Annamaria Matera Novo Nordisk Farmaceutici SpA
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00698126     History of Changes
Other Study ID Numbers: ANA-1897
Study First Received: June 13, 2008
Last Updated: June 15, 2012
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013