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Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes

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.
 
ClinicalTrials.gov Identifier: NCT00312104
Recruitment Status : Completed
First Posted : April 7, 2006
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE April 5, 2006
First Posted Date  ICMJE April 7, 2006
Last Update Posted Date January 27, 2017
Study Start Date  ICMJE April 2002
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2008)
HbA1c [ Time Frame: after 26 weeks of treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2006)
HbA1c after 26 weeks of treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2008)
  • Adverse events
  • Body weight
  • Blood glucose
  • Hypoglycaemia
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2006)
  • Blood glucose
  • Hypoglycaemia
  • Adverse events
  • Body weight
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes
Official Title  ICMJE Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes.
Brief Summary The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 Diabetes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: insulin detemir
  • Drug: insulin glargine
  • Drug: insulin aspart
Study Arms  ICMJE Not Provided
Publications * Pieber TR, Treichel HC, Hompesch B, Philotheou A, Mordhorst L, Gall MA, Robertson LI. Comparison of insulin detemir and insulin glargine in subjects with Type 1 diabetes using intensive insulin therapy. Diabet Med. 2007 Jun;24(6):635-42. Epub 2007 Mar 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2009)
325
Original Enrollment  ICMJE
 (submitted: April 5, 2006)
366
Actual Study Completion Date  ICMJE March 2003
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 1 diabetes for at least 12 months
  • Current daily insulin dose of more than 1.4 IU/kg
  • BMI lesser than or equal to 35 kg/m2
  • HbA1c greater than 7.5% and less than or equal to 12.0%
  • In Austria, age more than 19 years

Exclusion Criteria:

  • Proliferate retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany,   South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00312104
Other Study ID Numbers  ICMJE NN304-1372
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2017

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