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 A/S
ClinicalTrials.gov Identifier:
NCT00698126
First received: June 13, 2008
Last updated: June 15, 2012
Last verified: June 2012
  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:


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: 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 A/S
Investigators
Study Director: Annamaria Matera Novo Nordisk Farmaceutici SpA
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
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 April 15, 2014