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Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00274274
First received: January 9, 2006
Last updated: June 26, 2012
Last verified: June 2012
History of Changes

January 9, 2006
June 26, 2012
September 2005
November 2006   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 52 weeks ] [ Designated as safety issue: No ]
HbA1c after 52 weeks
Complete list of historical versions of study NCT00274274 on ClinicalTrials.gov Archive Site
  • Blood glucose profiles [ Designated as safety issue: No ]
  • Percentage of patients with HbA1c less than 7.0% after 52 weeks [ Designated as safety issue: No ]
  • Quality of Life [ Designated as safety issue: No ]
  • Frequency of BG measurements [ Designated as safety issue: No ]
  • Safety parameters [ Designated as safety issue: No ]
  • Duration of education [ Designated as safety issue: No ]
  • Blood glucose profiles
  • Percentage of patients with HbA1c less than 7.0% after 52 weeks
  • Quality of Life
  • Frequency of BG measurements
  • Safety parameters
  • Duration of education
Not Provided
Not Provided
 
Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 Diabetes
Efficacy and Safety of Insulin Aspart in a Fixed or Flexible Supplementary Insulin Therapy Regimen, With or Without Insulin Detemir in Type 2 Diabetes

This trial is conducted in Europe. This trial aims for a comparison of the efficacy and safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy, with or without Insulin Detemir plus Metformin, if needed, in subjects with type 2 diabetes.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin detemir
  • Drug: insulin aspart
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
373
November 2006
November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 Diabetes for more than 6 months
  • Treatment with 1 or more oral anti-diabetic drugs or insulin, or a combination of these for more than 3 months
  • Body Mass Index (BMI) less than or equal to 40 kg/m2
  • HbA1c 7.0-11.0%

Exclusion Criteria:

  • Treatment with short acting insulin(s) for longer than 10 days
  • Current treatment with TZDs. A TZD medication must be stopped at least 14 days before the randomization
  • Proliferative retinopathy or maculopathy requiring acute or laser treatment within the last 6 months
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00274274
NN304-1657, 2005-000319-87
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Til Rendschmidt Novo Nordisk Pharma GmbH
Novo Nordisk
June 2012

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