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Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With or Without Metformin and With/Without Pioglitazone in Type 2 Diabetes: An Extension Trial to NN1250-3582 (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01193322
First received: August 31, 2010
Last updated: December 8, 2011
Last verified: December 2011
History of Changes
  Purpose

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

The aim of this 26 week extension trial is to investigate the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes. Subjects who consent to participate in the extension trial will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: NN1250
Drug: insulin glargine
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 NN1250-3582 Comparing Safety and Efficacy of NN1250 and Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin With/Without OADs in Type 2 Diabetes (BEGIN™: BB)

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 78 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: after 78 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in HbA1c (glycosylated haemoglobin A1c) [ Time Frame: after 78 weeks of treatment ] [ Designated as safety issue: No ]
  • Plasma glucose profiles [ Time Frame: after 78 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 757
Study Start Date: September 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN1250
NN1250 injected subcutaneously (under the skin) in connection with main evening meal. The dose will be adjusted individually.
Drug: insulin aspart
Insulin aspart injected subcutaneously (under the skin) at each main meal. The dose will be adjusted individually.
Active Comparator: B Drug: insulin glargine
Insulin glargine injected according to approved label. The dose will be adjusted individually.
Drug: insulin aspart
Insulin aspart injected subcutaneously (under the skin) at each main meal. The dose will be adjusted individually.

  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 NN1250-3582
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193322

  Show 65 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Winnie Søjborg Pedersen 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: NCT01193322     History of Changes
Other Study ID Numbers: NN1250-3667, U1111-1114-9067, 2009-015816-17
Study First Received: August 31, 2010
Last Updated: December 8, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Bulgaria: Bulgarian Drug Agency
Romania: National Agency for Medicines and Medical Devices
Slovakia: State Institute for Drug Control
Ireland: Irish Medicines Board
Spain: Spanish agency of medicines and health care products
South Africa: Medicines Control Council
Hong Kong: Department of Health
Russia: Federal Service for Control of Health Care and Social Development
Turkey: Ministry of Health Drug and Pharmaceutical Department
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 17, 2012