A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification (DUAL™)

November 23, 2016 updated by: Novo Nordisk A/S

A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification (DUAL™ - Intensification)

This trial is conducted globally. The aim of the trial is to compare sequential addition of insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and metformin and in need of further intensification.

This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

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, B1704ETD
        • Novo Nordisk Investigational Site
      • Capital Federal, Argentina, C1056ABJ
        • Novo Nordisk Investigational Site
      • Corrientes, Argentina, 3400
        • Novo Nordisk Investigational Site
      • Salta, Argentina, 4400
        • Novo Nordisk Investigational Site
      • Zarate, Argentina, B2800DGH
        • Novo Nordisk Investigational Site
  • Australia
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
        • Novo Nordisk Investigational Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Novo Nordisk Investigational Site
      • Ipswich, Queensland, Australia, 4305
        • Novo Nordisk Investigational Site
      • Robina, Queensland, Australia, 4226
        • Novo Nordisk Investigational Site
    • Victoria
      • East Ringwood, Victoria, Australia, 3135
        • Novo Nordisk Investigational Site
  • Greece
      • Athens, Greece, GR-11527
        • Novo Nordisk Investigational Site
      • Ioannina, Greece, 45500
        • Novo Nordisk Investigational Site
      • Larissa, Greece, GR-41110
        • Novo Nordisk Investigational Site
      • Thessaloniki, Greece, GR-57001
        • Novo Nordisk Investigational Site
      • Thessaloniki, Greece, GR-54642
        • Novo Nordisk Investigational Site
  • Hungary
      • Eger, Hungary, 3300
        • Novo Nordisk Investigational Site
      • Gyor, Hungary, 9024
        • Novo Nordisk Investigational Site
      • Gyula, Hungary, 5700
        • Novo Nordisk Investigational Site
      • Miskolc, Hungary, 3526
        • Novo Nordisk Investigational Site
  • Mexico
      • Monterrey, Mexico, 64460
        • Novo Nordisk Investigational Site
    • Hidalgo
      • Pachuca, Hidalgo, Mexico, 42084
        • Novo Nordisk Investigational Site
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62250
        • Novo Nordisk Investigational Site
    • México, D.F.
      • Mexico City, México, D.F., Mexico, 03300
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Kazan, Russian Federation, 420073
        • Novo Nordisk Investigational Site
      • Kirov, Russian Federation, 610014
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 123448
        • Novo Nordisk Investigational Site
      • Novosibirsk, Russian Federation, 630117
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194358
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 199034
        • Novo Nordisk Investigational Site
      • St. Petersburg, Russian Federation, 194354
        • Novo Nordisk Investigational Site
      • Tomsk, Russian Federation, 634041
        • Novo Nordisk Investigational Site
      • Tomsk, Russian Federation, 634034
        • Novo Nordisk Investigational Site
      • Volgograd, Russian Federation, 400131
        • Novo Nordisk Investigational Site
  • Slovakia
      • Bardejov, Slovakia, 08501
        • Novo Nordisk Investigational Site
      • Dolny Kubin, Slovakia, 02601
        • Novo Nordisk Investigational Site
      • Kosice, Slovakia, 040 11
        • Novo Nordisk Investigational Site
      • Levice, Slovakia, 93401
        • Novo Nordisk Investigational Site
      • Poprad, Slovakia, 05801
        • Novo Nordisk Investigational Site
      • Povazska Bystrica, Slovakia, 01701
        • Novo Nordisk Investigational Site
      • Prievidza, Slovakia, 97101
        • Novo Nordisk Investigational Site
      • Trnava, Slovakia, 91701
        • Novo Nordisk Investigational Site
      • Velky Meder, Slovakia, 93201
        • Novo Nordisk Investigational Site
  • South Africa
      • Alberton, South Africa, 1449
        • Novo Nordisk Investigational Site
    • Gauteng
      • Midrand, Gauteng, South Africa, 1685
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4450
        • Novo Nordisk Investigational Site
    • North West
      • Brits, North West, South Africa, 0250
        • Novo Nordisk Investigational Site
  • Spain
      • Almería, Spain, 04001
        • Novo Nordisk Investigational Site
      • Granada, Spain, 18012
        • 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
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33316-2521
        • Novo Nordisk Investigational Site
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
    • Louisiana
      • Slidell, Louisiana, United States, 70461-4231
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novo Nordisk Investigational Site
    • Washington
      • Renton, Washington, United States, 98057
        • 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:

  • Completion (Visit 28) of NN9068-3952 with insulin degludec/liraglutide + metformin
  • HbA1c (glycosylated haemoglobin) above or equal to 7 percent at Visit 27 of NN9068-3952 trial

Exclusion Criteria:

  • Clinically significant diseases of the major organ systems
  • Screening calcitonin above or equal to 50 ng/L

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: Insulin degludec/liraglutide + Metformin
Drug: insulin degludec/liraglutide

Insulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin.

Dose individually adjusted.
Active Comparator: Insulin degludec/liraglutide + Insulin Aspart + Metformin
Drug: insulin degludec/liraglutide

Insulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin.

Dose individually adjusted.

Drug: insulin aspart
Dose titration of insulin aspart will be based on the respective pre-meal(s) and bedtime SMPG measured daily.

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
Change from baseline in HbA1c after 26 weeks of treatment.
Week 0, week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Body Weight
Time Frame: Week 0, week 26
Change from baseline in body weight after 26 weeks of treatment.
Week 0, week 26
Number of Treatment-emergent Confirmed Hypoglycaemic Episodes
Time Frame: Week 0 - 26
Treatment-emergent hypoglycaemic episodes: if the onset of the episode occurred on or after the first day of investigational medicinal product administration, and no later than 7 days after the last day on investigational medicinal product. Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded plasma glucose < 3.1 mmol/L (56 mg/dL).
Week 0 - 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.

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

April 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

March 27, 2014

First Posted (Estimate)

April 1, 2014

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9068-4119
  • 2013-002878-47 (EudraCT Number)
  • U1111-1145-0183 (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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