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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
ClinicalTrials.gov Identifier:
NCT01190956
First received: August 27, 2010
Last updated: December 8, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
 Drug: NN1250
Drug: insulin detemir
Drug: insulin aspart
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 370
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN1250
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.
Active Comparator: B 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed the six-month treatment period in trial NN1250-3585
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190956

Locations
Brazil
Sao Paulo, Brazil, 04022-001
Finland
Tampere, Finland, 33520
India
Thriruvananthapuram, India, 695 032
Italy
Milano, Italy, 20162
Japan
Miyazaki-shi, Japan, 880 0034
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
United Kingdom
Carmarthen, United Kingdom, SA31 2AF
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Nobuyuki Tanaka Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01190956     History of Changes
Other Study ID Numbers: NN1250-3725, U1111-1114-9479, 2009-015721-36, 22-0677
Study First Received: August 27, 2010
Last Updated: December 8, 2011
Health Authority: Brazil: National Health Surveillance Agency
Finland: Finnish Medicines Agency Fimea
India: Ministry of Health and Family Wellfare
Italy: Ministry of Health
Japan: Pharmaceuticals and medical devices agency (PMDA)
Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin aspart
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013