Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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: January 20, 2017
Last verified: January 2017
  Purpose
This trial was conducted in Europe and North America. The aim of this clinical trial was 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
Intervention Model: Parallel Assignment
Masking: No masking
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 ]
    Change from baseline in HbA1c after 26 weeks of treatment


Secondary Outcome Measures:
  • Change in Body Weight [ Time Frame: Week 0, Week 26 ]
    Change from baseline in body weight after 26 weeks of treatment


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   (Adult, Senior)
Sexes Eligible for Study:   All
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 Investigational Site
Birmingham, Alabama, United States, 35216
United States, Arizona
Novo Nordisk Investigational Site
Peoria, Arizona, United States, 85381
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85712
United States, California
Novo Nordisk Investigational Site
Beverly Hills, California, United States, 90211
Novo Nordisk Investigational Site
Escondido, California, United States, 92025
Novo Nordisk Investigational Site
La Jolla, California, United States, 92037
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90057
Novo Nordisk Investigational Site
Los Banos, California, United States, 93635
Novo Nordisk Investigational Site
Monterey, California, United States, 93940
Novo Nordisk Investigational Site
Palm Springs, California, United States, 92262
Novo Nordisk Investigational Site
Pasadena, California, United States, 91105
Novo Nordisk Investigational Site
Redondo Beach, California, United States, 90277
Novo Nordisk Investigational Site
San Mateo, California, United States, 94401
Novo Nordisk Investigational Site
Tarzana, California, United States, 91356-3551
Novo Nordisk Investigational Site
Tustin, California, United States, 92780
United States, Colorado
Novo Nordisk Investigational Site
Denver, Colorado, United States, 80209
Novo Nordisk Investigational Site
Golden, Colorado, United States, 80401
United States, Florida
Novo Nordisk Investigational Site
Boynton Beach, Florida, United States, 33472
Novo Nordisk Investigational Site
DeLand, Florida, United States, 32720
Novo Nordisk Investigational Site
Kissimmee, Florida, United States, 34741
Novo Nordisk Investigational Site
Miami, Florida, United States, 33156
Novo Nordisk Investigational Site
Orange Park, Florida, United States, 32073
Novo Nordisk Investigational Site
Plantation, Florida, United States, 33324
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33613
Novo Nordisk Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
Novo Nordisk Investigational Site
Conyers, Georgia, United States, 30094-5965
Novo Nordisk Investigational Site
Dunwoody, Georgia, United States, 30338
United States, Illinois
Novo Nordisk Investigational Site
Arlington Heights, Illinois, United States, 60004-2315
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60607
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60622
Novo Nordisk Investigational Site
Springfield, Illinois, United States, 62711
United States, Kansas
Novo Nordisk Investigational Site
Wichita, Kansas, United States, 67205
United States, Kentucky
Novo Nordisk Investigational Site
Crestview Hills, Kentucky, United States, 41017-3464
Novo Nordisk Investigational Site
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Novo Nordisk Investigational Site
Metairie, Louisiana, United States, 70002
United States, Maryland
Novo Nordisk Investigational Site
Glen Burnie, Maryland, United States, 21061
Novo Nordisk Investigational Site
Reisterstown, Maryland, United States, 21136-2516
Novo Nordisk Investigational Site
Silver Spring, Maryland, United States, 20910
United States, Michigan
Novo Nordisk Investigational Site
Ann Arbor, Michigan, United States, 48106-0482
United States, Minnesota
Novo Nordisk Investigational Site
Eagan, Minnesota, United States, 55123
United States, New York
Novo Nordisk Investigational Site
Smithtown, New York, United States, 11787
Novo Nordisk Investigational Site
Staten Island, New York, United States, 10301
United States, North Carolina
Novo Nordisk Investigational Site
Asheville, North Carolina, United States, 28801
Novo Nordisk Investigational Site
Burlington, North Carolina, United States, 27215-8700
Novo Nordisk Investigational Site
Whiteville, North Carolina, United States, 28472
Novo Nordisk Investigational Site
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45255
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45406
United States, Pennsylvania
Novo Nordisk Investigational Site
Altoona, Pennsylvania, United States, 16601
Novo Nordisk Investigational Site
Altoona, Pennsylvania, United States, 16602
Novo Nordisk Investigational Site
Harrisburg, Pennsylvania, United States, 17112-1900
Novo Nordisk Investigational Site
Langhorne, Pennsylvania, United States, 19047
United States, Rhode Island
Novo Nordisk Investigational Site
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Novo Nordisk Investigational Site
Newberry, South Carolina, United States, 29108-2249
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37404
Novo Nordisk Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Investigational Site
Arlington, Texas, United States, 76014
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75251
Novo Nordisk Investigational Site
Houston, Texas, United States, 77025
Novo Nordisk Investigational Site
Round Rock, Texas, United States, 78681
United States, Utah
Novo Nordisk Investigational Site
Ogden, Utah, United States, 84403
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84102
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Novo Nordisk Investigational Site
Chesapeake, Virginia, United States, 23320
United States, Washington
Novo Nordisk Investigational Site
Seattle, Washington, United States, 98105
Novo Nordisk Investigational Site
Spokane, Washington, United States, 99218
Bulgaria
Novo Nordisk Investigational Site
Burgas, Bulgaria, 8000
Novo Nordisk Investigational Site
Ruse, Bulgaria, 7000
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1606
Novo Nordisk Investigational Site
Stara Zagora, Bulgaria, 6000
Canada, British Columbia
Novo Nordisk Investigational Site
Chilliwack, British Columbia, Canada, V2P 4M9
Canada, Ontario
Novo Nordisk Investigational Site
Ottawa, Ontario, Canada, K1K 4L2
Novo Nordisk Investigational Site
Thornhill, Ontario, Canada, L4J 8L7
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M5C 2T2
Canada
Novo Nordisk Investigational Site
Quebec, Canada, G1N 4V3
Novo Nordisk Investigational Site
Quebec, Canada, G1V 4G5
Novo Nordisk Investigational Site
Quebec, Canada, G3K 2P8
France
Novo Nordisk Investigational Site
LA ROCHE-sur-YON cedex 9, France, 85295
Novo Nordisk Investigational Site
LA ROCHELLE cedex, France, 17019
Novo Nordisk Investigational Site
Le Creusot, France, 71200
Novo Nordisk Investigational Site
Nanterre, France, 92014
Novo Nordisk Investigational Site
Narbonne, France, 11108
Novo Nordisk Investigational Site
Nimes, France, 30006
Novo Nordisk Investigational Site
Paris, France, 75877
Novo Nordisk Investigational Site
Venissieux, France, 69200
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1125
Novo Nordisk Investigational Site
Debrecen, Hungary, 4043
Novo Nordisk Investigational Site
Eger, Hungary, 3300
Novo Nordisk Investigational Site
Gyula, Hungary, 5700
Novo Nordisk Investigational Site
Kaposvar, Hungary, H-7400
Novo Nordisk Investigational Site
Szeged, Hungary, H-6720
Netherlands
Novo Nordisk Investigational Site
Amsterdam, Netherlands, 1105 AZ
Novo Nordisk Investigational Site
Beek, Netherlands, 6191JW
Novo Nordisk Investigational Site
Etten-Leur, Netherlands, 4872 LP
Novo Nordisk Investigational Site
Hengelo, Netherlands, 7555 DL
Novo Nordisk Investigational Site
Hoogeveen, Netherlands, 7909 AA
Novo Nordisk Investigational Site
Lieshout, Netherlands, 5737 CB
Novo Nordisk Investigational Site
Utrecht, Netherlands, 3582 KE
Novo Nordisk Investigational Site
Zwijndrecht, Netherlands, 3331 LZ
Romania
Novo Nordisk Investigational Site
Oradea, Bihor, Romania, 410469
Novo Nordisk Investigational Site
Bacau, Romania, 600164
Novo Nordisk Investigational Site
Botosani, Romania, 710224
Novo Nordisk Investigational Site
Bucharest, Romania, 010816
Novo Nordisk Investigational Site
Galati, Romania, 800578
Novo Nordisk Investigational Site
Satu Mare, Romania, 440055
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01076647     History of Changes
Other Study ID Numbers: NN1250-3718
2009-011399-31 ( EudraCT Number )
U1111-1112-8770 ( Other Identifier: WHO )
Study First Received: February 25, 2010
Results First Received: October 13, 2015
Last Updated: January 20, 2017

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

ClinicalTrials.gov processed this record on May 24, 2017