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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00097084
First Posted: November 18, 2004
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
November 17, 2004
November 18, 2004
January 27, 2017
September 2004
December 2005   (Final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 1 year trial period ]
Not Provided
Complete list of historical versions of study NCT00097084 on ClinicalTrials.gov Archive Site
  • Adverse events
  • Body weight
  • Hypoglycemia
  • Blood glucose
  • Insulin Treatment Satisfaction
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin detemir
  • Drug: insulin glargine
  • Drug: insulin aspart
Not Provided
Hollander P, Cooper J, Bregnhøj J, Pedersen CB. A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes. Clin Ther. 2008 Nov;30(11):1976-87. doi: 10.1016/j.clinthera.2008.11.001.

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Finland,   France,   Norway,   Sweden,   United States
 
 
NCT00097084
NN304-1431
2004-000087-27 ( EudraCT Number )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

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