Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00097084
First received: November 17, 2004
Last updated: June 19, 2012
Last verified: June 2012

November 17, 2004
June 19, 2012
September 2004
December 2005   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 1 year trial period ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00097084 on ClinicalTrials.gov Archive Site
  • Adverse events [ Designated as safety issue: Yes ]
  • Body weight [ Designated as safety issue: No ]
  • Hypoglycemia [ Designated as safety issue: Yes ]
  • Blood glucose [ Designated as safety issue: No ]
  • Insulin Treatment Satisfaction [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes
Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type 2 diabetes.

Not Provided
Interventional
Phase 3
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 glargine
  • 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
324
December 2005
December 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes for at least 12 months
  • Treated with oral antidiabetic drugs or with any insulin regimen with or without oral antidiabetic drugs
  • BMI of maximum 40 kg/m2
  • HbA1c greater than or equal to 7.0% and less than or equal to 11.0%

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Impaired hepatic or renal function
  • Cardiac problems or uncontrolled hypertension
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Finland,   France,   Norway,   Sweden
 
NCT00097084
NN304-1431, 2004-000087-27
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Per Clauson, MD, PhD Novo Nordisk A/S
Novo Nordisk A/S
June 2012

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