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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:
ClinicalTrials.gov Identifier:
NCT00698126
First Posted: June 17, 2008
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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 ]

Secondary Outcome Measures:
  • Number of serious and non serious drug reactions [ Time Frame: during 26 weeks ]
  • Number of serious adverse event [ Time Frame: during 26 weeks ]
  • Number of all major (daytime and nocturnal) hypoglycaemic events [ Time Frame: during 26 weeks ]
  • Number of major hypoglycaemic events related to omission of a meal after injection [ Time Frame: during 26 weeks ]
  • Number of major hypoglycaemic events related to physical exercise of at least 30 min duration [ Time Frame: during 26 weeks ]
  • Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks preceding each study visit [ Time Frame: after 26 weeks ]
  • Weight and waist circumference change [ Time Frame: during 26 weeks ]
  • Number of hypoglycaemia events in the two different treatment groups based on the HbA1c level [ Time Frame: after 26 weeks ]
  • Quality of Life (QoL) [ Time Frame: after 26 weeks ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698126


Locations
Italy
Novo Nordisk Investigational Site
Rome, Italy, 00144
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00698126     History of Changes
Other Study ID Numbers: ANA-1897
First Submitted: June 13, 2008
First Posted: June 17, 2008
Last Update Posted: October 28, 2016
Last Verified: October 2016

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