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:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00698126
First received: June 13, 2008
Last updated: August 8, 2014
Last verified: August 2014

June 13, 2008
August 8, 2014
October 2007
May 2009   (final data collection date for primary outcome measure)
Number of major hypoglycaemic events reported as serious adverse drug reactions [ Time Frame: after 26 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00698126 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Observational Study of Patients Using NovoRapid® or Soluble Human Insulin for Treatment of Type 2 Diabetes
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

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Any subject with type 2 diabetes who is already in treatment with insulin aspart or soluble human insulin will be included in the study

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: soluble human insulin
    Observational study; use of the products as in the normal clinical practice conditions
    Other Name: Actrapid
  • Drug: biphasic insulin aspart
    Observational study; use of the products as in the normal clinical practice conditions
  • A
    Intervention: Drug: soluble human insulin
  • B
    Intervention: Drug: biphasic insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4099
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00698126
ANA-1897
No
Not Provided
Novo Nordisk A/S
Not Provided
Study Director: Annamaria Matera Novo Nordisk Farmaceutici SpA
Novo Nordisk A/S
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP