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An Observational Study of Insulin Aspart and, if Necessary, Insulin Levemir (FlexPen®) in the Evening or at Bedtime

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01487421
First received: November 25, 2011
Last updated: December 5, 2011
Last verified: December 2011
History of Changes

November 25, 2011
December 5, 2011
July 2003
October 2004   (final data collection date for primary outcome measure)
HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01487421 on ClinicalTrials.gov Archive Site
  • Fasting blood glucose (FBG) [ Designated as safety issue: No ]
  • 2-hours postprandial blood glucose [ Designated as safety issue: No ]
  • Hypoglycemia [ Designated as safety issue: No ]
  • Weight development [ Designated as safety issue: No ]
  • Adverse Drug Reactions (ADRs) including Serious Adverse Drug Reactions (SADRs) [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study of Insulin Aspart and, if Necessary, Insulin Levemir (FlexPen®) in the Evening or at Bedtime
The Physiological Therapy of Type 2 Diabetes - NovoRapid® FlexPen® Before Meals, Additionally Levemir® FlexPen® in the Evening or at Bedtime if Needed

This study is conducted in Europe. The aim of this study is investigate the potential of a supplementary insulin therapy regimen (SIT) as intensification for insufficiently controlled patients with type 2 diabetes in a normal diabetes care setting.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with insufficiently controlled type 2 diabetes mellitus treated with diet, OAD (oral anti-diabetes drug), long acting insulin, premixed insulin or a combination
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin aspart
    Subjects were observed over a time period of 12 weeks after initiation of a supplementary insulin therapy regimen (SIT) with insulin aspart at mealtimes. Administrated subcutaneously (s.c., under the skin)
  • Drug: insulin detemir
    Insulin detemir were added to insulin aspart in the evening or at bedtime, if needed. Administrated subcutaneously (s.c., under the skin)
SIT
Interventions:
  • Drug: insulin aspart
  • Drug: insulin detemir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2134
October 2004
October 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • OAD monotherapy
  • OAD combination therapy
  • Therapy with OAD and basal insulin
  • Conventional insulin therapy with premixed insulin
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01487421
ANA-1934
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: H. Andersen Novo Nordisk
Novo Nordisk
December 2011

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