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Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes: An Extension Trial to NN1250-3579 (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01193309
First received: August 31, 2010
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  Purpose

This trial will be conducted in Europe and North America. The aim of this 52 week extension trial is to investigate the long-term safety and tolerability in terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes. Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week trial NN1250-3579.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: NN1250
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 NN1250-3579 Comparing Safety and Efficacy of NN1250 Plus OAD(s) With Insulin Glargine Plus OAD(s) in Type 2 Diabetes (BEGIN™: Once 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 (AEs) [ 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 ]

Secondary Outcome Measures:
  • Change from baseline in HbA1c (glycosylated haemoglobin A1c) [ Time Frame: after 104 weeks of treatment ] [ Designated as safety issue: No ]
  • Plasma glucose profiles [ Time Frame: after 104 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 725
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN1250
Injected s.c. (under the skin) once daily. The doses will be individually adjusted.
Active Comparator: B Drug: insulin glargine
Injected s.c. (under the skin) once daily. The doses 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 NN1250-3579
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193309

  Show 72 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Lone Esbensen 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: NCT01193309     History of Changes
Other Study ID Numbers: NN1250-3643, U1111-1114-9426, 2009-015754-38
Study First Received: August 31, 2010
Last Updated: January 17, 2012
Health Authority: Austria: AGES PharmMed
Belgium: Federal Agency for Medicines and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medicinal Devices (BfarM)
Finland: Finnish Medicines Agency Fimea
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Norway: Norwegian Medicines Agency
Serbia: Medicines and Medical Devices Agency of Serbia
Spain: Spanish Drug Agency and Medicinal Products
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013