Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01076647
First received: February 25, 2010
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

This trial is conducted in Europe and North America. The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs).


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec
Drug: insulin glargine
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 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of Insulin naïve Subjects With Type 2 Diabetes Mellitus Currently Treated With OADs Qualifying for Intensified Treatment (BEGIN™: EASY™)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Body Weight [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]

Enrollment: 467
Study Start Date: March 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg 3TW Drug: insulin degludec
Will be injected subcutaneously (under the skin) once daily three times weekly.
Active Comparator: IGlar OD Drug: insulin glargine
Will be injected subcutaneously (under the skin) once daily administered at the same time each day.

  Eligibility

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

Inclusion Criteria:

  • Type 2 diabetes (diagnosed clinically) for at least 6 months
  • Insulin naïve subjects (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
  • Current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily)-Insulin secretagogue (sulfonylurea (SU) or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
  • HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
  • BMI (Body Mass Index) below or equal to 45.0 kg/m^2

Exclusion Criteria:

  • Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs), Exenatide or Liraglutide
  • Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
  • Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076647

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center
Birmingham, Alabama, United States, 35216
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Peoria, Arizona, United States, 85381
Novo Nordisk Clinical Trial Call Center
Tucson, Arizona, United States, 85712
United States, California
Novo Nordisk Clinical Trial Call Center
Escondido, California, United States, 92026
Novo Nordisk Clinical Trial Call Center
La Jolla, California, United States, 92037
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90057
Novo Nordisk Clinical Trial Call Center
Los Banos, California, United States, 93635
Novo Nordisk Clinical Trial Call Center
Monterey, California, United States, 93940
Novo Nordisk Clinical Trial Call Center
Palm Springs, California, United States, 92262
Novo Nordisk Clinical Trial Call Center
Pasadena, California, United States, 91105
Novo Nordisk Clinical Trial Call Center
Redondo Beach, California, United States, 90277
Novo Nordisk Clinical Trial Call Center
San Mateo, California, United States, 94401
Novo Nordisk Clinical Trial Call Center
Tarzana, California, United States, 91356-3551
Novo Nordisk Clinical Trial Call Center
Tustin, California, United States, 92780
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Denver, Colorado, United States, 80209-3806
Novo Nordisk Clinical Trial Call Center
Golden, Colorado, United States, 80401
United States, Florida
Novo Nordisk Clinical Trial Call Center
Boynton Beach, Florida, United States, 33472
Novo Nordisk Clinical Trial Call Center
DeLand, Florida, United States, 32720
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33156
Novo Nordisk Clinical Trial Call Center
Orange Park, Florida, United States, 32073
Novo Nordisk Clinical Trial Call Center
Plantation, Florida, United States, 33324
Novo Nordisk Clinical Trial Call Center
Tampa, Florida, United States, 33613
Novo Nordisk Clinical Trial Call Center
West Palm Beach, Florida, United States, 33401
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Dunwoody, Georgia, United States, 30338
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Arlington Heights, Illinois, United States, 60004-2315
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60607
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60622
United States, Kansas
Novo Nordisk Clinical Trial Call Center
Wichita, Kansas, United States, 67205
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Crestview Hills, Kentucky, United States, 41017-3464
Novo Nordisk Clinical Trial Call Center
Madisonville, Kentucky, United States, 42431-1661
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
Metairie, Louisiana, United States, 70002
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Glen Burnie, Maryland, United States, 21061
Novo Nordisk Clinical Trial Call Center
Reisterstown, Maryland, United States, 21136-2516
United States, Minnesota
Novo Nordisk Clinical Trial Call Center
Eagan, Minnesota, United States, 55123
United States, New York
Novo Nordisk Clinical Trial Call Center
Staten Island, New York, United States, 10301
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Burlington, North Carolina, United States, 27215-8700
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45255
Novo Nordisk Clinical Trial Call Center
Dayton, Ohio, United States, 45406
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Harrisburg, Pennsylvania, United States, 17112-1900
Novo Nordisk Clinical Trial Call Center
Tipton, Pennsylvania, United States, 16684
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States, 37404
Novo Nordisk Clinical Trial Call Center
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Clinical Trial Call Center
Arlington, Texas, United States, 76014
Novo Nordisk Clinical Trial Call Center
Austin, Texas, United States, 78731
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75251
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77025
United States, Utah
Novo Nordisk Clinical Trial Call Center
Ogden, Utah, United States, 84403
United States, Washington
Novo Nordisk Clinical Trial Call Center
Seattle, Washington, United States, 98195
Novo Nordisk Clinical Trial Call Center
Spokane, Washington, United States, 99207
Bulgaria
Stara Zagora, Bulgaria, 6003
Canada, British Columbia
Chilliwack, British Columbia, Canada, V2P 4M9
France
Narbonne, France, 11108
Hungary
Szeged, Hungary, H-6701
Netherlands
Amsterdam, Netherlands, 1105 AZ
Romania
Oradea, Bihor, Romania, 410469
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01076647     History of Changes
Other Study ID Numbers: NN1250-3718, 2009-011399-31, U1111-1112-8770
Study First Received: February 25, 2010
Last Updated: November 26, 2013
Health Authority: Canada: Health Canada
Romania: National Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Bulgaria: Bulgarian Drug Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Hungary: National Institute of Pharmacy
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014