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

January 20, 2017 updated by: Novo Nordisk A/S

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™)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

467

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • 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
        • Novo Nordisk Investigational Site
  • Canada
      • Quebec, Canada, G1V 4G5
        • Novo Nordisk Investigational Site
      • Quebec, Canada, G1N 4V3
        • Novo Nordisk Investigational Site
      • Quebec, Canada, G3K 2P8
        • Novo Nordisk Investigational Site
    • British Columbia
      • Chilliwack, British Columbia, Canada, V2P 4M9
        • Novo Nordisk Investigational Site
    • Ontario
      • Ottawa, Ontario, Canada, K1K 4L2
        • Novo Nordisk Investigational Site
      • Thornhill, Ontario, Canada, L4J 8L7
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M5C 2T2
        • Novo Nordisk Investigational Site
  • France
      • 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
        • Novo Nordisk Investigational Site
  • Hungary
      • 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
        • Novo Nordisk Investigational Site
  • Netherlands
      • 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
        • Novo Nordisk Investigational Site
  • Romania
      • 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
        • Novo Nordisk Investigational Site
    • Bihor
      • Oradea, Bihor, Romania, 410469
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Novo Nordisk Investigational Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Novo Nordisk Investigational Site
      • Tucson, Arizona, United States, 85712
        • Novo Nordisk Investigational Site
    • California
      • 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
        • Novo Nordisk Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80209
        • Novo Nordisk Investigational Site
      • Golden, Colorado, United States, 80401
        • Novo Nordisk Investigational Site
    • Florida
      • 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
        • Novo Nordisk Investigational Site
    • Georgia
      • Conyers, Georgia, United States, 30094-5965
        • Novo Nordisk Investigational Site
      • Dunwoody, Georgia, United States, 30338
        • Novo Nordisk Investigational Site
    • Illinois
      • 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
        • Novo Nordisk Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67205
        • Novo Nordisk Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017-3464
        • Novo Nordisk Investigational Site
      • Madisonville, Kentucky, United States, 42431
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Novo Nordisk Investigational Site
    • Maryland
      • 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
        • Novo Nordisk Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106-0482
        • Novo Nordisk Investigational Site
    • Minnesota
      • Eagan, Minnesota, United States, 55123
        • Novo Nordisk Investigational Site
    • New York
      • Smithtown, New York, United States, 11787
        • Novo Nordisk Investigational Site
      • Staten Island, New York, United States, 10301
        • Novo Nordisk Investigational Site
    • North Carolina
      • 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
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45255
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45406
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novo Nordisk Investigational Site
      • Altoona, Pennsylvania, United States, 16601
        • Novo Nordisk Investigational Site
      • Harrisburg, Pennsylvania, United States, 17112-1900
        • Novo Nordisk Investigational Site
      • Langhorne, Pennsylvania, United States, 19047
        • Novo Nordisk Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Novo Nordisk Investigational Site
    • South Carolina
      • Newberry, South Carolina, United States, 29108-2249
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
    • Texas
      • 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
        • Novo Nordisk Investigational Site
    • Utah
      • 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
        • Novo Nordisk Investigational Site
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Novo Nordisk Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Novo Nordisk Investigational Site
      • Spokane, Washington, United States, 99218
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IGlar OD
Drug: insulin glargine
Will be injected subcutaneously (under the skin) once daily administered at the same time each day.
Experimental: IDeg 3TW
Drug: insulin degludec
Will be injected subcutaneously (under the skin) once daily three times weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin (HbA1c)
Time Frame: Week 0, Week 26
Change from baseline in HbA1c after 26 weeks of treatment
Week 0, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: Week 0, Week 26
Change from baseline in body weight after 26 weeks of treatment
Week 0, Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 25, 2010

First Submitted That Met QC Criteria

February 25, 2010

First Posted (Estimate)

February 26, 2010

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-3718
  • 2009-011399-31 (EudraCT Number)
  • U1111-1112-8770 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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