Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin (BEGIN™)

January 19, 2017 updated by: Novo Nordisk A/S

A Trial Comparing Efficacy and Safety of NN1250 With Sitagliptin in Insulin Naive Subjects With Type 2 Diabetes (BEGIN™ : EARLY)

This trial will be conducted in Africa, Asia, North America and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

458

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

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Novo Nordisk Investigational Site
      • Caba, Argentina, C1440AAD
        • Novo Nordisk Investigational Site
      • Ciudad Autónoma de BsAs, Argentina, C1406FWY
        • Novo Nordisk Investigational Site
      • Córdoba, Argentina, 5000
        • Novo Nordisk Investigational Site
      • Mar del Plata, Argentina, B7602CBM
        • Novo Nordisk Investigational Site
      • Mendoza, Argentina, 5500
        • Novo Nordisk Investigational Site
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3S 2N6
        • Novo Nordisk Investigational Site
    • Ontario
      • Cambridge, Ontario, Canada, N1R 7L6
        • Novo Nordisk Investigational Site
      • Chatham, Ontario, Canada, N7L 1C1
        • Novo Nordisk Investigational Site
      • London, Ontario, Canada, N6H 4P2
        • Novo Nordisk Investigational Site
      • London, Ontario, Canada, N6P 1A9
        • Novo Nordisk Investigational Site
      • Smiths Falls, Ontario, Canada, K7A 4W8
        • Novo Nordisk Investigational Site
      • St.Catharines, Ontario, Canada, L2N 7H8
        • Novo Nordisk Investigational Site
    • Quebec
      • Gatineau, Quebec, Canada, J8V 2P5
        • Novo Nordisk Investigational Site
      • Laval, Quebec, Canada, H7T 2P5
        • Novo Nordisk Investigational Site
      • Montreal, Quebec, Canada, H3J 2V5
        • Novo Nordisk Investigational Site
      • St-Marc-des-Carrières, Quebec, Canada, G0A 4B0
        • Novo Nordisk Investigational Site
  • India
      • Nagpur, India, 440012
        • Novo Nordisk Investigational Site
      • Pune, India, 411011
        • Novo Nordisk Investigational Site
      • Pune, India, 411005
        • Novo Nordisk Investigational Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 001
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 003
        • Novo Nordisk Investigational Site
      • Bangalore, Karnataka, India, BANGALORE
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600029
        • Novo Nordisk Investigational Site
      • Madurai, Tamil Nadu, India, 625 020
        • Novo Nordisk Investigational Site
  • Mexico
      • Guadalajara, Mexico, 44600
        • Novo Nordisk Investigational Site
      • Mexico City, Mexico, 11850
        • Novo Nordisk Investigational Site
  • South Africa
      • Umhlanga, South Africa, 4320
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7460
        • Novo Nordisk Investigational Site
  • Turkey
      • Ankara, Turkey, 06100
        • Novo Nordisk Investigational Site
      • Denizli, Turkey, 20070
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34098
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34390
        • Novo Nordisk Investigational Site
      • Izmir, Turkey, 35340
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Novo Nordisk Investigational Site
    • California
      • Concord, California, United States, 94520
        • Novo Nordisk Investigational Site
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
      • Greenbrae, California, United States, 94904
        • Novo Nordisk Investigational Site
      • La Jolla, California, United States, 92037
        • Novo Nordisk Investigational Site
      • Long Beach, California, United States, 90806
        • Novo Nordisk Investigational Site
      • Mission Hills, California, United States, 91345
        • Novo Nordisk Investigational Site
      • Palm Springs, California, United States, 92262
        • Novo Nordisk Investigational Site
      • Torrance, California, United States, 90504
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598-3347
        • Novo Nordisk Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80239-3133
        • Novo Nordisk Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33765
        • Novo Nordisk Investigational Site
      • Inverness, Florida, United States, 34452
        • Novo Nordisk Investigational Site
      • Kissimmee, Florida, United States, 34741
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33135
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33125-1655
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33186
        • Novo Nordisk Investigational Site
      • Ocala, Florida, United States, 34471
        • Novo Nordisk Investigational Site
      • Ponte Vedra, Florida, United States, 32081
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33603
        • Novo Nordisk Investigational Site
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Novo Nordisk Investigational Site
      • Decatur, Georgia, United States, 30033
        • Novo Nordisk Investigational Site
      • Dunwoody, Georgia, United States, 30338
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, United States, 60624
        • Novo Nordisk Investigational Site
      • Springfield, Illinois, United States, 62711
        • Novo Nordisk Investigational Site
    • Indiana
      • Huntington, Indiana, United States, 46750-1404
        • Novo Nordisk Investigational Site
    • Iowa
      • Council Bluffs, Iowa, United States, 51501
        • Novo Nordisk Investigational Site
      • Des Moines, Iowa, United States, 50314-2610
        • Novo Nordisk Investigational Site
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Novo Nordisk Investigational Site
    • Michigan
      • Livonia, Michigan, United States, 48152-3501
        • Novo Nordisk Investigational Site
      • Troy, Michigan, United States, 48085-5524
        • Novo Nordisk Investigational Site
    • Minnesota
      • St. Paul, Minnesota, United States, 55108
        • Novo Nordisk Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Novo Nordisk Investigational Site
      • Albuquerque, New Mexico, United States, 87108
        • Novo Nordisk Investigational Site
    • New York
      • New Hyde Park, New York, United States, 11042
        • 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
      • Greenville, North Carolina, United States, 27834-5784
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224-2215
        • Novo Nordisk Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15241
        • Novo Nordisk Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Novo Nordisk Investigational Site
      • Murrells Inlet, South Carolina, United States, 29576
        • Novo Nordisk Investigational Site
    • Texas
      • Corpus Christi, Texas, United States, 78404
        • Novo Nordisk Investigational Site
      • El Paso, Texas, United States, 79912
        • Novo Nordisk Investigational Site
      • El Paso, Texas, United States, 79905-2709
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77070
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Novo Nordisk Investigational Site
      • Tomball, Texas, United States, 77375
        • Novo Nordisk Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Novo Nordisk Investigational Site
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Novo Nordisk Investigational Site
    • Washington
      • Spokane, Washington, United States, 99208
        • 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
  • Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination 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 or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the maximal daily dose according to local labelling -Pioglitazone: minimum half of the maximal daily dose according to local labelling or maximum tolerated dose
  • Body Mass Index (BMI) below or equal to 40.0 kg/m^2
  • HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis

Exclusion Criteria:

  • Use within the last 3 months prior to Visit 1 of: exenatide, liraglutide, rosiglitazone or acarbose
  • 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)
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
  • Cancer and medical history 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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IDeg OD
Drug: insulin degludec
Injected under the skin once daily for 26 weeks. The doses will be individually adjusted.
EXPERIMENTAL: DPP-IV inhibitor
Drug: sitagliptin
Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks

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

January 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

January 8, 2010

First Submitted That Met QC Criteria

January 8, 2010

First Posted (ESTIMATE)

January 11, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-3580
  • U1111-1111-7126 (OTHER: 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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on insulin degludec

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe