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Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00104182
First received: February 23, 2005
Last updated: June 26, 2012
Last verified: June 2012
History of Changes

February 23, 2005
June 26, 2012
February 2005
February 2006   (final data collection date for primary outcome measure)
HbA1C [ Time Frame: after 20 weeks ] [ Designated as safety issue: No ]
HbA1C results
Complete list of historical versions of study NCT00104182 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 ]
  • Adverse events
  • body weight
  • Hypoglycemia
  • Blood glucose
 
 
 
Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes
Efficacy and Safety Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening as Add-on to Oral Antidiabetic Drug(s) in Patients With Type 2 Diabetes

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.
 
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 NPH
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
503
February 2006
February 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes for at least 12 months
  • Currently treated with Oral Antidiabetic Drugs
  • BMI lesser than or equal to 40 kg/m2
  • HbA1c greater than or equal 7.5 and lesser than or equal to 11%

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Denmark,   France,   Italy,   Netherlands,   Norway,   Spain
 
NCT00104182
NN304-1632, 2004-001461-18
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
 
Study Director: Per Clauson, MD, PhD Novo Nordisk
Novo Nordisk
June 2012

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