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

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

A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: LOW VOLUME)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

460

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2H 2G4
        • Novo Nordisk Investigational Site
      • Edmonton, Alberta, Canada, T5J 3N4
        • Novo Nordisk Investigational Site
    • British Columbia
      • Langley, British Columbia, Canada, V3A 4H9
        • Novo Nordisk Investigational Site
    • Ontario
      • Cambridge, Ontario, Canada, N1R 7L6
        • Novo Nordisk Investigational Site
      • Cornwall, Ontario, Canada, K6H 4M4
        • Novo Nordisk Investigational Site
      • Hamilton, Ontario, Canada, L8L 5G8
        • Novo Nordisk Investigational Site
      • Hamilton, Ontario, Canada, L8M 1K7
        • Novo Nordisk Investigational Site
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Novo Nordisk Investigational Site
      • Mississauga, Ontario, Canada, L5B 4A2
        • Novo Nordisk Investigational Site
      • Sudbury, Ontario, Canada, P3C 5K7
        • Novo Nordisk Investigational Site
    • Quebec
      • St. Romuald, Quebec, Canada, G6W 5M6
        • Novo Nordisk Investigational Site
  • France
      • Antibes, France, 06600
        • Novo Nordisk Investigational Site
      • Besancon, France, 25030
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
      • Pointe à Pitre, France, 97159
        • Novo Nordisk Investigational Site
      • Rennes, France, 35056
        • Novo Nordisk Investigational Site
      • Sète, France, 34200
        • Novo Nordisk Investigational Site
      • Venissieux, France, 69200
        • Novo Nordisk Investigational Site
  • Ireland
      • Dublin, Ireland, DUBLIN 15
        • Novo Nordisk Investigational Site
      • Dublin, Ireland, DUBLIN 7
        • Novo Nordisk Investigational Site
      • Dublin, Ireland, DUBLIN 8
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620102
        • Novo Nordisk Investigational Site
      • Kemerovo, Russian Federation, 650099
        • Novo Nordisk Investigational Site
      • Krasnoyarsk, Russian Federation, 660062
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 121356
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 199034
        • Novo Nordisk Investigational Site
      • Voronezh, Russian Federation, 394018
        • Novo Nordisk Investigational Site
  • South Africa
      • Alberton, South Africa, 1449
        • Novo Nordisk Investigational Site
    • Eastern Cape
      • East London, Eastern Cape, South Africa, 5201
        • Novo Nordisk Investigational Site
      • Port Elizabeth, Eastern Cape, South Africa, 6045
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4000
        • Novo Nordisk Investigational Site
  • Ukraine
      • Kiev, Ukraine, 04114
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Abergavenny, United Kingdom, NP7 7EG
        • Novo Nordisk Investigational Site
      • Ashton-Under-Lyne, United Kingdom, OL6 9RW
        • Novo Nordisk Investigational Site
      • Atherstone, United Kingdom, CV9 1EU
        • Novo Nordisk Investigational Site
      • Ayr, United Kingdom, KA6 6DX
        • Novo Nordisk Investigational Site
      • Bath, United Kingdom, BA2 1NH
        • Novo Nordisk Investigational Site
      • Bolton, United Kingdom, BL3 6TL
        • Novo Nordisk Investigational Site
      • Chester, United Kingdom, CH2 1UL
        • Novo Nordisk Investigational Site
      • Chorley, United Kingdom, PR7 1PP
        • Novo Nordisk Investigational Site
      • Coventry, United Kingdom, CV2 2DX
        • Novo Nordisk Investigational Site
      • Epworth, United Kingdom, DN9 1EP
        • Novo Nordisk Investigational Site
      • Harrogate, United Kingdom, HG1 5JP
        • Novo Nordisk Investigational Site
      • Letchworth, United Kingdom, SG6 4UB
        • Novo Nordisk Investigational Site
      • Livingstone, United Kingdom, EH54 6PP
        • Novo Nordisk Investigational Site
      • Llantrisant, United Kingdom, CF72 8XR
        • Novo Nordisk Investigational Site
      • Maidstone, United Kingdom, ME16 9QQ
        • Novo Nordisk Investigational Site
      • Oldham, United Kingdom, OL1 2JH
        • Novo Nordisk Investigational Site
      • Rugby, United Kingdom, CV22 5PX
        • Novo Nordisk Investigational Site
      • Salford, United Kingdom, M6 8HD
        • Novo Nordisk Investigational Site
      • Trowbridge, United Kingdom, BA14 8QA
        • Novo Nordisk Investigational Site
      • Whitby, United Kingdom, YO21 1SD
        • Novo Nordisk Investigational Site
      • Wrexham, United Kingdom, LL13 7TD
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Novo Nordisk Investigational Site
    • Arizona
      • Gilbert, Arizona, United States, 85295
        • Novo Nordisk Investigational Site
      • Phoenix, Arizona, United States, 85018
        • Novo Nordisk Investigational Site
      • Tucson, Arizona, United States, 85741
        • Novo Nordisk Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Investigational Site
      • Huntington Beach, California, United States, 92648
        • Novo Nordisk Investigational Site
      • Mission Hills, California, United States, 91345
        • Novo Nordisk Investigational Site
      • Montclair, California, United States, 91763
        • Novo Nordisk Investigational Site
      • National City, California, United States, 91950
        • Novo Nordisk Investigational Site
      • Norco, California, United States, 92860
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92111
        • Novo Nordisk Investigational Site
      • Valencia, California, United States, 91355
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045-7402
        • Novo Nordisk Investigational Site
    • Florida
      • Hollywood, Florida, United States, 33021
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32209-6511
        • Novo Nordisk Investigational Site
      • Longwood, Florida, United States, 32779
        • Novo Nordisk Investigational Site
      • Ocala, Florida, United States, 34471
        • Novo Nordisk Investigational Site
      • Ponte Vedra, Florida, United States, 32081
        • Novo Nordisk Investigational Site
      • Vero Beach, Florida, United States, 32960
        • Novo Nordisk Investigational Site
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Novo Nordisk Investigational Site
      • Lawrenceville, Georgia, United States, 30046
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, United States, 60611
        • Novo Nordisk Investigational Site
      • Crystal Lake, Illinois, United States, 60012
        • Novo Nordisk Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Novo Nordisk Investigational Site
      • Greenfield, Indiana, United States, 46140
        • Novo Nordisk Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50314-2610
        • Novo Nordisk Investigational Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Novo Nordisk Investigational Site
    • Louisiana
      • Slidell, Louisiana, United States, 70461-4231
        • Novo Nordisk Investigational Site
    • Maryland
      • Greenbelt, Maryland, United States, 20770
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Novo Nordisk Investigational Site
    • Michigan
      • Southfield, Michigan, United States, 48034
        • Novo Nordisk Investigational Site
      • Southfield, Michigan, United States, 48075
        • Novo Nordisk Investigational Site
      • Troy, Michigan, United States, 48098
        • Novo Nordisk Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Novo Nordisk Investigational Site
    • Mississippi
      • Biloxi, Mississippi, United States, 39531-4535
        • Novo Nordisk Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • Novo Nordisk Investigational Site
    • Montana
      • Billings, Montana, United States, 59102
        • Novo Nordisk Investigational Site
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Novo Nordisk Investigational Site
      • Mine Hill, New Jersey, United States, 07803
        • Novo Nordisk Investigational Site
    • New York
      • Brooklyn, New York, United States, 11203-2711
        • Novo Nordisk Investigational Site
      • New York, New York, United States, 10025
        • Novo Nordisk Investigational Site
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Novo Nordisk Investigational Site
      • Chapel Hill, North Carolina, United States, 27517
        • Novo Nordisk Investigational Site
      • Charlotte, North Carolina, United States, 28277
        • Novo Nordisk Investigational Site
      • Greensboro, North Carolina, United States, 27408
        • Novo Nordisk Investigational Site
    • Ohio
      • Franklin, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Novo Nordisk Investigational Site
      • Melrose Park, Pennsylvania, United States, 19027
        • Novo Nordisk Investigational Site
      • Norristown, Pennsylvania, United States, 19401
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk Investigational Site
    • South Carolina
      • Peak, South Carolina, United States, 29122
        • Novo Nordisk Investigational Site
    • Texas
      • Desoto, Texas, United States, 75115
        • Novo Nordisk Investigational Site
      • El Paso, Texas, United States, 79912
        • Novo Nordisk Investigational Site
      • Killeen, Texas, United States, 76543
        • Novo Nordisk Investigational Site
      • Plano, Texas, United States, 75093
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77479
        • Novo Nordisk Investigational Site
    • Utah
      • St. George, Utah, United States, 84790
        • Novo Nordisk Investigational Site
    • Washington
      • Renton, Washington, United States, 98057
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Insulin naïve subject (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 an insulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitors (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 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-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
  • HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
  • Body Mass Index (BMI) maximum 45.0 kg/m^2
  • Type 2 diabetes (diagnosed clinically) for at least 6 months
  • Ability and willingness to adhere to the protocol including performance of self monitored plasma glucose (SMPG) profiles according to the protocol

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 [for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods]
  • 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
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
Experimental: IDeg 200 U/mL OD
Drug: insulin degludec
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

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 Fasting Plasma Glucose (FPG)
Time Frame: Week 0, Week 26
Change from baseline in FPG 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)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 12, 2010

First Submitted That Met QC Criteria

February 12, 2010

First Posted (Estimate)

February 15, 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

  • NN1250-3672
  • 2009-010662-28 (EudraCT Number)
  • U1111-1112-8977 (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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