A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus (DUAL™ V)

December 7, 2018 updated by: Novo Nordisk A/S

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus (DUAL™ V - Basal Insulin Switch)

This trial is conducted globally. The aim of the trial is to compare the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
557

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Blacktown, New South Wales, Australia, 2148
        • Novo Nordisk Investigational Site
      • 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-14233
        • Novo Nordisk Investigational Site
      • 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
      • Thessaloniki, Greece, GR-56403
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, H-1134
        • Novo Nordisk Investigational Site
      • 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
      • Durango, Mexico, 34000
        • Novo Nordisk Investigational Site
      • 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, 634050
        • Novo Nordisk Investigational Site
      • Tomsk, Russian Federation, 634041
        • Novo Nordisk Investigational Site
      • Volgograd, Russian Federation, 400131
        • Novo Nordisk Investigational Site
      • Vsevolozhsk, Russian Federation, 188643
        • Novo Nordisk Investigational Site
  • Slovakia
      • Bardejov, Slovakia, 08501
        • Novo Nordisk Investigational Site
      • Dolny Kubin, Slovakia, 02601
        • Novo Nordisk Investigational Site
      • Kosice, Slovakia, 04001
        • Novo Nordisk Investigational Site
      • Kosice, Slovakia, 040 11
        • Novo Nordisk Investigational Site
      • Levice, Slovakia, 93401
        • Novo Nordisk Investigational Site
      • Lubochna, Slovakia, 03491
        • 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
  • 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
      • Los Alamitos, California, United States, 90720
        • Novo Nordisk Investigational Site
      • Palm Springs, California, United States, 92262
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92111
        • Novo Nordisk Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Novo Nordisk Investigational Site
      • Colorado Springs, Colorado, United States, 80906
        • Novo Nordisk Investigational Site
    • Florida
      • Bradenton, Florida, United States, 34201
        • Novo Nordisk Investigational Site
      • Fort Lauderdale, Florida, United States, 33316
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33165
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33027
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33603
        • Novo Nordisk Investigational Site
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Novo Nordisk Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47725
        • Novo Nordisk Investigational Site
      • Michigan City, Indiana, United States, 46360
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
      • Louisville, Kentucky, United States, 40213
        • Novo Nordisk Investigational Site
    • Louisiana
      • Slidell, Louisiana, United States, 70461-4231
        • Novo Nordisk Investigational Site
    • Missouri
      • Saint Charles, Missouri, United States, 63303
        • Novo Nordisk Investigational Site
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Novo Nordisk Investigational Site
    • Ohio
      • Franklin, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Novo Nordisk Investigational Site
      • Oklahoma City, Oklahoma, United States, 73104
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19140
        • Novo Nordisk Investigational Site
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75390-9302
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78224
        • Novo Nordisk Investigational Site
    • Utah
      • West Jordan, Utah, United States, 84088-8871
        • Novo Nordisk Investigational Site
    • Washington
      • Renton, Washington, United States, 98057
        • Novo Nordisk Investigational Site
      • Spokane, Washington, United States, 99218
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 mellitus - HbA1c 7.0-10.0% [53-86 mmol/mol] (both inclusive) by central laboratory analysis - Current treatment with insulin glargine for at least 90 days prior to screening - Stable daily dose of insulin glargine between 20 units and 50 units (both inclusive) for at least 56 days prior to screening. Total daily dose should be within the range of 20-50 units, both inclusive, on the day of screening, but individual fluctuations of plus/minus 10 procent within the 56 days prior to screening are acceptable - Stable daily dose of metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening - Body mass index (BMI) below or equal to 40 kg/m^2 Exclusion Criteria: - Any use of oral antidiabetic agents (OADs) (except for metformin) within 90 days prior to Visit 1 (screening) - Current use of any drug (except metformin and insulin glargine) or anticipated change inconcomitant medication, which in the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids) - Previous and/or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness includinggestational diabetes is allowed at the discretion of the investigator) - Previous and/or current treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide) - Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to 2.5 times upper normal range (UNR) - Impaired renal function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (1.4 mg/dL) for females, or as allowed according to local contraindications for metformin - Screening calcitonin above or equal to 50 ng/L - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) - History of chronic pancreatitis or idiopathic acute pancreatitis

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Insulin degludec/liraglutide OD plus metformin
Drug: insulin degludec/liraglutide
Insulin degludec/liraglutide is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.
Active Comparator: Insulin glargine OD plus metformin
Drug: insulin glargine
Insulin glargine is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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: During 26 weeks of treatment
Confirmed hypoglycaemic episodes were defined as either: Severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or an episode biochemically confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.
During 26 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9068-3952
  • 2012-004413-14 (EudraCT Number)
  • U1111-1135-1003 (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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Locations

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