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Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00972283
First received: September 3, 2009
Last updated: December 6, 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 clinical trial is to compare NN1250 with insulin glargine plus insulin aspart with/without metformin and with/without pioglitazone in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial with the exception of metformin and pioglitazone.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: NN1250
Drug: insulin glargine
Drug: insulin aspart
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin ± Treatment With Metformin, ± Pioglitazone in Subjects With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment (BEGIN™: BB)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c change from baseline [ Time Frame: after 52 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hypoglycaemic episodes [ Time Frame: after 52 weeks treatment ] [ Designated as safety issue: No ]
  • Plasma glucose profiles [ Time Frame: after 52 weeks treatment ] [ Designated as safety issue: No ]

Enrollment: 1006
Study Start Date: September 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (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:

  • Type 2 diabetes mellitus for at least 6 months
  • Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without OAD (oral anti-diabetics drug) prior to trial start
  • HbA1c 7.0 - 10.0 % (both inclusive)
  • BMI below or equal to 40.0 kg/m2

Exclusion Criteria:

  • Treatment with other insulin regimens than premix, self-mix, basal only, basal bolus within 3 months
  • Cardiovascular disease within the last 6 months
  • Uncontrolled treated/untreated severe hypertension
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
  • Cancer and medical history of cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972283

  Show 76 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Malene Bording Krüger, B.Sc Novo Nordisk
  More Information

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

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00972283     History of Changes
Other Study ID Numbers: NN1250-3582, 2008-005777-35, U1111-1111-8648
Study First Received: September 3, 2009
Last Updated: December 6, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Bulgaria: Bulgarian Drug Agency
Romania: National Medicines Agency
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
Pioglitazone
Insulin aspart
 Glargine
Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013