Text Size

Observational Study of Patients Using Levemir® or Insulatard® as Start Insulin for Treatment of Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00715351
First received: July 11, 2008
Last updated: June 26, 2012
Last verified: June 2012
History of Changes

July 11, 2008
June 26, 2012
May 2007
July 2008   (final data collection date for primary outcome measure)
Body weight change [ Time Frame: at 3 months and 6 months after baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00715351 on ClinicalTrials.gov Archive Site
  • Hypoglycemic events [ Time Frame: at 3 months and 6 months after baseline ] [ Designated as safety issue: No ]
  • Changes in glycaemic parameters [ Time Frame: at 3 months and 6 months after baseline ] [ Designated as safety issue: No ]
  • Safety parameters by collecting (serious) adverse events and the pregnancies. [ Time Frame: at 3 months and 6 months after baseline ] [ Designated as safety issue: Yes ]
  • Evaluation of general well-being by using the WHO-5 well-being questionnaire (Appendix I). [ Time Frame: at 3 months and 6 months after baseline ] [ Designated as safety issue: No ]
  • Treatment satisfaction of subjects treated with insulin Levemir or NPH insulin by using insulin satisfaction ('Tevredenheid met insuline behandeling': Appendix II) [ Time Frame: at 3 months and 6 months after baseline ] [ Designated as safety issue: No ]
  • Satisfaction of physicians who treat the subjects with insulin Levemir or NPH in-sulin by using a scale of 0-10 (Appendix III). [ Time Frame: at 3 months and 6 months after baseline ] [ Designated as safety issue: No ]
  • Changes in doses [ Time Frame: at 3 months and 6 months after baseline ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: at 3 months and 6 months after baseline ] [ Designated as safety issue: No ]
  • Changes in daily blood glucose values [ Time Frame: at 3 months and 6 months after baseline ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study of Patients Using Levemir® or Insulatard® as Start Insulin for Treatment of Diabetes
Efficacy and Safety of Glycaemic Control of Levemir® or Insulatard® in Patients With Type 2 Diabetes

This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes with Levemir® compared to Insulatard® under normal clinical practice conditions.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Insulin naïve patients with type 2 diabetes treated with oral antidiabetics
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin detemir
    Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician
  • Drug: insulin NPH
    Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician
  • A
    Intervention: Drug: insulin detemir
  • B
    Intervention: Drug: insulin NPH
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
342
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes failing on oral blood glucose lowering therapy, and requiring insulin therapy.

Exclusion Criteria:

  • Type 1 diabetes
  • Previous use of insulin
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   Slovenia
 
NCT00715351
NN304-1896
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Beril Tom-de Vries, MD, PhD Novo Nordisk Farma B.V.
Novo Nordisk
June 2012

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