Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184665
First received: September 13, 2005
Last updated: June 19, 2012
Last verified: June 2012

September 13, 2005
June 19, 2012
June 2004
September 2006   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after a two-year trial period ] [ Designated as safety issue: No ]
HbA1c after a two-year trial period
Complete list of historical versions of study NCT00184665 on ClinicalTrials.gov Archive Site
  • Adverse events [ Designated as safety issue: Yes ]
  • Body weight [ Designated as safety issue: No ]
  • Antibodies [ Designated as safety issue: Yes ]
  • Body composition [ Designated as safety issue: No ]
  • Blood glucose [ Designated as safety issue: No ]
  • Hypoglycaemia [ Designated as safety issue: Yes ]
  • Adverse events
  • body weight
  • Antibodies
  • Body-composition
  • Blood glucose
  • Hypoglycaemia
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin detemir
  • Drug: insulin NPH
  • 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
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
Both
18 Years and older
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
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Jens Larsen 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