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

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ClinicalTrials.gov Identifier: NCT00698126
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: soluble human insulin Drug: biphasic insulin aspart

Study Type : Observational
Actual Enrollment : 4099 participants
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
Study Start Date : October 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Number of major hypoglycaemic events reported as serious adverse drug reactions [ Time Frame: after 26 weeks ]

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


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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

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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00698126     History of Changes
Other Study ID Numbers: ANA-1897
First Posted: June 17, 2008    Key Record Dates
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