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™: EASY AM)

This trial is conducted in Africa, Asia, Europe, and North America. The aim of this clinical trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes currently treated with metformin alone or with metformin combined with an oral anti-diabetic drug (OAD) 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
      • St John's, Canada, A1B 3V6
        • Novo Nordisk Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T3C 3P1
        • Novo Nordisk Investigational Site
      • Edmonton, Alberta, Canada, T5J 3N4
        • Novo Nordisk Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Novo Nordisk Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
        • Novo Nordisk Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Novo Nordisk Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Novo Nordisk Investigational Site
      • Mississauga, Ontario, Canada, L5M 2V8
        • Novo Nordisk Investigational Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Novo Nordisk Investigational Site
      • Sudbury, Ontario, Canada, P3E 1Y8
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M4P 1P2
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M3J 1N2
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Novo Nordisk Investigational Site
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • Novo Nordisk Investigational Site
      • Sherbrooke, Quebec, Canada, J1G 5K2
        • Novo Nordisk Investigational Site
  • Czech Republic
      • Brandys nad Labem, Czech Republic, 250 01
        • Novo Nordisk Investigational Site
      • Mlada Boleslav, Czech Republic, 293 50
        • Novo Nordisk Investigational Site
      • Ostrava, Czech Republic, 707 02
        • Novo Nordisk Investigational Site
      • Prague, Czech Republic, 120 00
        • Novo Nordisk Investigational Site
      • Trutnov, Czech Republic, 541 01
        • Novo Nordisk Investigational Site
  • Israel
      • Petah-Tikva, Israel, 49372
        • Novo Nordisk Investigational Site
      • Rehovot, Israel, 76100
        • Novo Nordisk Investigational Site
      • Rishon Le Zion, Israel, 75650
        • Novo Nordisk Investigational Site
      • Tel Hashomer, Israel, 52621
        • Novo Nordisk Investigational Site
      • Zefat, Israel, 13100
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Manati, Puerto Rico, 00674
        • Novo Nordisk Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 811 08
        • Novo Nordisk Investigational Site
      • Kosice, Slovakia, 04-001
        • Novo Nordisk Investigational Site
      • Moldava nad Bodvou, Slovakia, 045 01
        • Novo Nordisk Investigational Site
      • Nove Zamky, Slovakia, 940 59
        • Novo Nordisk Investigational Site
      • Presov, Slovakia, 080 01
        • Novo Nordisk Investigational Site
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2198
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 1LD
        • Novo Nordisk Investigational Site
      • Aldershot, United Kingdom, GU12 5BA
        • Novo Nordisk Investigational Site
      • Birmingham, United Kingdom, B9 5SS
        • Novo Nordisk Investigational Site
      • Chippenham, United Kingdom, SN15 2SB
        • Novo Nordisk Investigational Site
      • Exeter, United Kingdom, EX2 5AX
        • Novo Nordisk Investigational Site
      • Guildford, United Kingdom, GU2 7XX
        • Novo Nordisk Investigational Site
      • Nuneaton, United Kingdom, CV10 7DJ
        • Novo Nordisk Investigational Site
      • Portsmouth, United Kingdom, PO6 3LY
        • Novo Nordisk Investigational Site
      • Watford, United Kingdom, WD18 0HB
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Northridge, California, United States, 91325
        • Novo Nordisk Investigational Site
      • Palm Springs, California, United States, 92262
        • Novo Nordisk Investigational Site
      • Paramount, California, United States, 90723
        • Novo Nordisk Investigational Site
      • Santa Ana, California, United States, 92704
        • Novo Nordisk Investigational Site
      • Spring Valley, California, United States, 91978
        • Novo Nordisk Investigational Site
      • Tustin, California, United States, 92780
        • Novo Nordisk Investigational Site
    • Florida
      • Melbourne, Florida, United States, 32901
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
      • Columbus, Georgia, United States, 31909
        • Novo Nordisk Investigational Site
      • Perry, Georgia, United States, 31069
        • Novo Nordisk Investigational Site
    • Illinois
      • Olympia Fields, Illinois, United States, 60461
        • Novo Nordisk Investigational Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Novo Nordisk Investigational Site
      • Fishers, Indiana, United States, 46038-1862
        • Novo Nordisk Investigational Site
      • Franklin, Indiana, United States, 46131-9121
        • Novo Nordisk Investigational Site
      • Indianapolis, Indiana, United States, 46254
        • Novo Nordisk Investigational Site
      • Muncie, Indiana, United States, 47304
        • Novo Nordisk Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
      • Paducah, Kentucky, United States, 42003
        • Novo Nordisk Investigational Site
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • Michigan
      • Interlochen, Michigan, United States, 49643
        • Novo Nordisk Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Novo Nordisk Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Novo Nordisk Investigational Site
      • St. Peters, Missouri, United States, 63376
        • Novo Nordisk Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Novo Nordisk Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68521
        • Novo Nordisk Investigational Site
    • New Jersey
      • Hamilton, New Jersey, United States, 08619
        • Novo Nordisk Investigational Site
      • Toms River, New Jersey, United States, 08755-8050
        • Novo Nordisk Investigational Site
    • New York
      • Syracuse, New York, United States, 13210
        • Novo Nordisk Investigational Site
      • West Seneca, New York, United States, 14224
        • Novo Nordisk Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Novo Nordisk Investigational Site
      • Winston Salem, North Carolina, United States, 27103
        • Novo Nordisk Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Novo Nordisk Investigational Site
      • Cleveland, Ohio, United States, 44115
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45439
        • Novo Nordisk Investigational Site
      • Mentor, Ohio, United States, 44060
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Pottstown, Pennsylvania, United States, 19464
        • Novo Nordisk Investigational Site
      • Upper St.Clair, Pennsylvania, United States, 15241
        • Novo Nordisk Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29455
        • Novo Nordisk Investigational Site
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
      • Simpsonville, South Carolina, United States, 29681
        • Novo Nordisk Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Novo Nordisk Investigational Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Novo Nordisk Investigational Site
      • Arlington, Texas, United States, 76014-2010
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Fort Worth, Texas, United States, 76113
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77074
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77095
        • Novo Nordisk Investigational Site
      • Irving, Texas, United States, 75061-2210
        • Novo Nordisk Investigational Site
      • Plano, Texas, United States, 75024
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78224
        • Novo Nordisk Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Novo Nordisk Investigational Site
    • Virginia
      • Fredericksburg, Virginia, United States, 22408-2674
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23225-4017
        • Novo Nordisk Investigational Site
      • Virginia Beach, Virginia, United States, 23462
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Menomonee Falls, Wisconsin, United States, 53051-4049
        • 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:

  • 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 insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least three 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 secretaguogue (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-inhibitor (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) below or equal to 45.0 kg/m^2

Exclusion Criteria:

  • Use within the last 3 months prior to Visit 1 of: thiazoledinediones, 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 3 times weekly (3TW)
Drug: insulin degludec
Injected subcutaneously (under the skin) three times weekly. 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 26
Change from baseline in HbA1c after week 26
Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: Week 26
Change from baseline in body weight after week 26
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

February 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

  • NN1250-3724
  • 2009-011398-33 (EudraCT Number)
  • U1111-1113-2412 (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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