Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin (BEGIN™)

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

A Trial Comparing the Efficacy and Safety of Adding Liraglutide Versus Addition of Insulin Aspart With the Largest Meal to Insulin Degludec, Both in Combination With Metformin, in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification (BEGIN™: VICTOZA® ADD-ON)

This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes.

Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

413

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

  • Austria
      • Feldkirch, Austria, 6807
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1090
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1130
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1030
        • Novo Nordisk Investigational Site
      • Wolfsberg, Austria, 9400
        • Novo Nordisk Investigational Site
  • Belgium
      • Brussels, Belgium, 1070
        • Novo Nordisk Investigational Site
      • Gent, Belgium, 9000
        • Novo Nordisk Investigational Site
      • Leuven, Belgium, 3000
        • Novo Nordisk Investigational Site
      • Liège, Belgium, 4000
        • Novo Nordisk Investigational Site
  • Canada
      • Quebec, Canada, G1V 4G2
        • Novo Nordisk Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3N4
        • Novo Nordisk Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
        • Novo Nordisk Investigational Site
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Novo Nordisk Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Novo Nordisk Investigational Site
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
        • Novo Nordisk Investigational Site
      • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
        • Novo Nordisk Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 0A4
        • Novo Nordisk Investigational Site
    • Ontario
      • Mississauga, Ontario, Canada, L5M 2V8
        • Novo Nordisk Investigational Site
      • Ottawa, Ontario, Canada, K1N 6N5
        • Novo Nordisk Investigational Site
      • Ottawa, Ontario, Canada, K1K 4L2
        • Novo Nordisk Investigational Site
      • Scarborough, Ontario, Canada, M1E 5E9
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M5C 2T2
        • Novo Nordisk Investigational Site
    • Quebec
      • St-Marc-des-Carrières, Quebec, Canada, G0A 4B0
        • Novo Nordisk Investigational Site
      • St. Romuald, Quebec, Canada, G6W 5M6
        • Novo Nordisk Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 65691
        • Novo Nordisk Investigational Site
      • Hradec Kralove, Czech Republic, 500 05
        • Novo Nordisk Investigational Site
      • Plzen, Czech Republic, 304 60
        • Novo Nordisk Investigational Site
      • Prague 4, Czech Republic, 140 21
        • Novo Nordisk Investigational Site
  • Denmark
      • Esbjerg, Denmark, 6700
        • Novo Nordisk Investigational Site
      • Hillerød, Denmark, 3400
        • Novo Nordisk Investigational Site
      • Holbæk, Denmark, 4300
        • Novo Nordisk Investigational Site
      • København S, Denmark, 2300
        • Novo Nordisk Investigational Site
      • Odense, Denmark, 5000
        • Novo Nordisk Investigational Site
      • Silkeborg, Denmark, 8600
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, 00260
        • Novo Nordisk Investigational Site
      • Joensuu, Finland, 80100
        • Novo Nordisk Investigational Site
      • Kerava, Finland, FI-04200
        • Novo Nordisk Investigational Site
      • Lohja, Finland, 08100
        • Novo Nordisk Investigational Site
      • Oulu, Finland, 90100
        • Novo Nordisk Investigational Site
      • Tampere, Finland, 33210
        • Novo Nordisk Investigational Site
  • France
      • Montigny-les-Metz, France, 57950
        • Novo Nordisk Investigational Site
      • Nanterre, France, 92014
        • Novo Nordisk Investigational Site
      • Nimes, France, 30006
        • Novo Nordisk Investigational Site
      • Venissieux, France, 69200
        • Novo Nordisk Investigational Site
  • Germany
      • Berlin, Germany, 12163
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 13055
        • Novo Nordisk Investigational Site
      • Dresden, Germany, 01307
        • Novo Nordisk Investigational Site
      • Essen, Germany, 45329
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22391
        • Novo Nordisk Investigational Site
      • Hohenmölsen, Germany, 06679
        • Novo Nordisk Investigational Site
      • Neuwied, Germany, 56564
        • Novo Nordisk Investigational Site
      • Pohlheim, Germany, 35415
        • Novo Nordisk Investigational Site
      • Rehburg-Loccum, Germany, 31547
        • Novo Nordisk Investigational Site
      • Rehlingen-Siersburg, Germany, 66780
        • Novo Nordisk Investigational Site
      • Speyer, Germany, 67346
        • Novo Nordisk Investigational Site
      • St. Ingbert, Germany, 66386
        • Novo Nordisk Investigational Site
  • Norway
      • Bekkestua, Norway, 1357
        • Novo Nordisk Investigational Site
      • Elverum, Norway, 2408
        • Novo Nordisk Investigational Site
      • Hamar, Norway, 2318
        • Novo Nordisk Investigational Site
      • Kongsvinger, Norway, 2212
        • Novo Nordisk Investigational Site
      • Oslo, Norway, 0407
        • Novo Nordisk Investigational Site
      • Stavanger, Norway, 4011
        • Novo Nordisk Investigational Site
      • Trondheim, Norway, NO-7030
        • Novo Nordisk Investigational Site
      • Ålesund, Norway, 6003
        • Novo Nordisk Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Novo Nordisk Investigational Site
      • Kragujevac, Serbia, 34000
        • Novo Nordisk Investigational Site
      • Nis, Serbia, 18000
        • Novo Nordisk Investigational Site
      • Novi Sad, Serbia, 21000
        • Novo Nordisk Investigational Site
  • Spain
      • Almería, Spain, 04001
        • Novo Nordisk Investigational Site
      • Antequera, Spain, 29200
        • Novo Nordisk Investigational Site
      • El Ferrol, Spain, 15405
        • Novo Nordisk Investigational Site
      • Inca, Spain, 07300
        • Novo Nordisk Investigational Site
      • Palma de Mallorca, Spain, 07014
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41010
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41003
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Concord, California, United States, 94520-1926
        • Novo Nordisk Investigational Site
      • La Jolla, California, United States, 92037
        • Novo Nordisk Investigational Site
      • Lancaster, California, United States, 93534
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • National City, California, United States, 91950
        • Novo Nordisk Investigational Site
      • Northridge, California, United States, 91325
        • Novo Nordisk Investigational Site
      • Palm Springs, California, United States, 92262
        • Novo Nordisk Investigational Site
      • Santa Monica, California, United States, 90404
        • Novo Nordisk Investigational Site
      • Spring Valley, California, United States, 91978
        • Novo Nordisk Investigational Site
      • Tarzana, California, United States, 91356-3551
        • Novo Nordisk Investigational Site
      • Tustin, California, United States, 92780
        • Novo Nordisk Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Novo Nordisk Investigational Site
      • Melbourne, Florida, United States, 32901
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33156
        • Novo Nordisk Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Novo Nordisk Investigational Site
      • Palm Harbor, Florida, United States, 34684
        • Novo Nordisk Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Novo Nordisk Investigational Site
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Novo Nordisk Investigational Site
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Novo Nordisk Investigational Site
      • Slidell, Louisiana, United States, 70461-4231
        • Novo Nordisk Investigational Site
    • Maryland
      • North East, Maryland, United States, 21901
        • Novo Nordisk Investigational Site
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • New Jersey
      • Toms River, New Jersey, United States, 08755-8050
        • Novo Nordisk Investigational Site
    • New York
      • Northport, New York, United States, 11768
        • Novo Nordisk Investigational Site
      • Staten Island, New York, United States, 10301
        • Novo Nordisk Investigational Site
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Melrose Park, Pennsylvania, United States, 19027
        • Novo Nordisk Investigational Site
      • Upper St. Clair, Pennsylvania, United States, 15241
        • Novo Nordisk Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Novo Nordisk Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Novo Nordisk Investigational Site
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Novo Nordisk Investigational Site
      • Humboldt, Tennessee, United States, 38343
        • Novo Nordisk Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, United States, 76014
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • Fort Worth, Texas, United States, 76113
        • Novo Nordisk Investigational Site
      • Irving, Texas, United States, 75061-2210
        • Novo Nordisk Investigational Site
      • Lubbock, Texas, United States, 79423
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78215
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77479
        • 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:

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
  • The subject must have completed the end of treatment visit of NN1250-3643 with Insulin degludec once daily + metformin.
  • Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol

Exclusion Criteria:

  • Participated in NN1250-3643 and treated with insulin glargine
  • Previous treatment with glucacon like peptide (GLP-1) receptor agonists (e.g. exenatide, liraglutide)
  • Impaired liver function, defined as alanine aminotransferase (ALAT) 2.5 times the upper limit of normal at end of treatment in NN1250-3643
  • Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for metformin [For France: glomerular filtration rate below 60 ml/min, calculated by the Cockroft & Gault formula] at end of treatment in NN1250-3643.

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
Experimental: IDeg (non-randomised)
Drug: insulin degludec
Injected s.c. (under the skin) once daily. The doses will be individually adjusted
Experimental: IDeg + IAsp
Drug: insulin degludec
Injected s.c. (under the skin) once daily. The doses will be individually adjusted
Drug: insulin aspart
Injected s.c. (under the skin) once daily. The doses will be individually adjusted.
Experimental: IDeg + liraglutide
Drug: insulin degludec
Injected s.c. (under the skin) once daily. The doses will be individually adjusted
Drug: liraglutide
Injected s.c. (under the skin) once daily. The doses will be individually adjusted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
Time Frame: week 0, week 26
Values for change in HbA1c from baseline to 26 weeks of treatment period.
week 0, week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG)
Time Frame: week 0, week 26
Values for change in FPG in mmol/L from baseline to week 26 of randomised period.
week 0, week 26
Change From Baseline in Body Weight
Time Frame: week 0, week 26
Corresponds to the values of change in body weight in kilograms from baseline to week 26.
week 0, week 26
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
Time Frame: Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.
Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value < 3.1 mmol/L (56 mg/dL).
Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.

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

September 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 4, 2011

First Submitted That Met QC Criteria

July 4, 2011

First Posted (Estimate)

July 6, 2011

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

  • NN1250-3948
  • 2011-001493-25 (EudraCT Number)
  • U1111-1120-2782 (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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