Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes: An Extension Trial to NN1250-3585 (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01190956
First received: August 27, 2010
Last updated: December 8, 2011
Last verified: December 2011

August 27, 2010
December 8, 2011
September 2010
June 2011   (final data collection date for primary outcome measure)
  • Number of adverse events [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01190956 on ClinicalTrials.gov Archive Site
  • Change from baseline in HbA1c (glycosylated haemoglobin A1c) [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
  • Plasma glucose profiles [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes: An Extension Trial to NN1250-3585
An Extension Trial to NN1250-3585 Investigating Safety and Efficacy of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen (BEGIN™: BB T1)

This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to investigate safety and efficacy of NN1250 compared to insulin detemir in subjects with type 1 diabetes mellitus.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • Drug: NN1250
    Injected subcutaneously (under the skin) once daily.The dose will be individually adjusted.
  • Drug: insulin detemir
    Injected subcutaneously (under the skin) once daily. The dose will be individually adjusted.
  • Drug: insulin aspart
    Injected subcutaneously (under the skin) as mealtime insulin.The dose will be individually adjusted.
  • Experimental: A
    Interventions:
    • Drug: NN1250
    • Drug: insulin aspart
  • Active Comparator: B
    Interventions:
    • Drug: insulin detemir
    • 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
370
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completed the six-month treatment period in trial NN1250-3585
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Finland,   India,   Italy,   Japan,   Macedonia, The Former Yugoslav Republic of,   United Kingdom
 
NCT01190956
NN1250-3725, U1111-1114-9479, 2009-015721-36, 22-0677
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Nobuyuki Tanaka Novo Nordisk A/S
Novo Nordisk A/S
December 2011

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