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Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00184665
First Posted: September 16, 2005
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
September 13, 2005
September 16, 2005
January 27, 2017
June 2004
September 2006   (Final data collection date for primary outcome measure)
HbA1c [ Time Frame: after a two-year trial period ]
HbA1c after a two-year trial period
Complete list of historical versions of study NCT00184665 on ClinicalTrials.gov Archive Site
  • Adverse events
  • Body weight
  • Antibodies
  • Body composition
  • Blood glucose
  • Hypoglycaemia
  • Antibodies
  • Body weight
  • Body composition
  • Blood glucose
  • Hypoglycaemia
  • Adverse events
Not Provided
Not Provided
 
Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes
2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes.
This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin detemir
  • Drug: insulin NPH
  • Drug: insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
501
September 2006
September 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes
  • Currently on basal-bolus regimen
  • BMI = 35.0 kg/m2
  • HbA1c =11.0%

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Cardial problems
  • Uncontrolled hypertension
  • Impaired hepatic or renal function
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Bulgaria,   Croatia,   India,   Macedonia, The Former Yugoslav Republic of,   Malaysia,   Romania,   South Africa,   Turkey
 
 
NCT00184665
NN304-1595
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