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Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes: An Extension to Trial NN1250-3583 (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01198041
First received: September 8, 2010
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  Purpose

This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of this 52 week extension trial is to investigate the long-term safety and safety in terms of comparing NN1250 plus insulin aspart with insulin glargine plus insulin aspart in patients with type 1 diabetes. Subjects who consent to participate in the extension trial will continue receiving treatment with either NN1250 or insulin glargine as previously randomly allocated in the 52 week trial NN1250-3583.


Condition Intervention Phase
Diabetes Mellitus, Type 1
 Drug: NN1250
Drug: insulin aspart
Drug: insulin glargine
 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 Trial NN1250-3583 Comparing Safety and Efficacy of NN1250 With Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin, in Type 1 Diabetes (BEGIN™: BB T1 LONG)

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 104 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: after 104 weeks of treatment ] [ Designated as safety issue: No ]
  • Change in insulin antibodies [ Time Frame: week 0, week 104 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HbA1c (Glycosylated Haemoglobin A1c) [ Time Frame: week 0, week 104 ] [ Designated as safety issue: No ]
  • Plasma glucose profiles [ Time Frame: after 104 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 472
Study Start Date: September 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN1250
Injected subcutaneously (under the skin) with the evening meal. The dose will be individually adjusted.
Drug: insulin aspart
Injected subcutaneously (under the skin) with meals. The dose will be individually adjusted.
Active Comparator: B Drug: insulin aspart
Injected subcutaneously (under the skin) with meals. The dose will be individually adjusted.
Drug: insulin glargine
Injected subcutaneously (under the skin) once daily. 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:

  • Completion of the 52 week treatment period in trial NN1250-3583
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198041

  Show 55 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Anders Brauten Eriksen 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: NCT01198041     History of Changes
Other Study ID Numbers: NN1250-3644, 2009-015755-24, U1111-1116-1578
Study First Received: September 8, 2010
Last Updated: January 17, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medicinal Devices (BfarM)
Russia: Federal Service for Control of Health Care and Social Development
South Africa: Medicines Control Council
United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)
United States: Food and Drug Administration

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
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013