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Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00383877
First received: October 3, 2006
Last updated: June 26, 2012
Last verified: June 2012
History of Changes

October 3, 2006
June 26, 2012
September 2006
August 2007   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 20 weeks of treatment ] [ Designated as safety issue: No ]
HbA1c after 20 weeks of treatment
Complete list of historical versions of study NCT00383877 on ClinicalTrials.gov Archive Site
  • FBG [ Time Frame: after 20 weeks of treatment ] [ Designated as safety issue: No ]
  • Safety profile [ Time Frame: during 20 weeks treatment ] [ Designated as safety issue: Yes ]
  • Proportion of subjects achieving HbA1c less than or equal to 7.0% [ Time Frame: after 20 weeks of treatment ] [ Designated as safety issue: No ]
  • Within-subject variation of self measured blood glucose (SMBG) before breakfast during the trial at the end of the trial [ Time Frame: before breakfast during the trial at the end of the trial ] [ Designated as safety issue: No ]
  • FBG after 20 weeks of treatment.
  • Safety profile during 20 weeks treatment.
  • Proportion of subjects achieving HbA1c less than or equal to 7.0% after 20 weeks of treatment.
  • Within-subject variation of self measured blood glucose (SMBG) before breakfast during the trial at the end of the trial.
Not Provided
Not Provided
 
Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes
Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes

This trial is conducted in China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).
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 NPH
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
263
August 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • HbA1C greater than 7.5% and less than or equal to 11.0%
  • Currently on any oral antidiabetic drug (OAD) more than or equal to 3 months

Exclusion Criteria:

  • Previous acute treatment with insulin for more than 7 days.
  • Treatment with OAD(s) which does not adhere to the approval labeling.
  • Proliferate retinopathy or maculopathy that has required acute treatment within the last year.
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia, that may interfere with study participation as judged by the Investigator.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00383877
NN304-1684
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Han Lijun Pharmaceuticals Co., Ltd.
Study Director: Cheng Yuwei Pharmaceuticals Co., Ltd.
Novo Nordisk
June 2012

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