The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III)

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

The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III -GLP-1 Switch)

This trial is conducted in Europe, Oceania and the United States of America (USA).

The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.

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.
438

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

  • Australia
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Novo Nordisk Investigational Site
      • Merewether, New South Wales, Australia, 2291
        • Novo Nordisk Investigational Site
    • South Australia
      • Keswick, South Australia, Australia, 5035
        • Novo Nordisk Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Novo Nordisk Investigational Site
      • Melbourne, Victoria, Australia, 3004
        • Novo Nordisk Investigational Site
  • France
      • Antibes, France, 06600
        • Novo Nordisk Investigational Site
      • Boulogne Billancourt, France, 92100
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • Montigny-les-Metz, France, 57950
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
      • Nimes, France, 30006
        • Novo Nordisk Investigational Site
      • Sète, France, 34200
        • Novo Nordisk Investigational Site
      • Venissieux, France, 69200
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1042
        • Novo Nordisk Investigational Site
      • Debrecen, Hungary, 4043
        • Novo Nordisk Investigational Site
      • Nyíregyhaza, Hungary, 4400
        • Novo Nordisk Investigational Site
      • Székesfehérvár, Hungary, 8000
        • Novo Nordisk Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 851 01
        • Novo Nordisk Investigational Site
      • Bratislava, Slovakia, 831 01
        • Novo Nordisk Investigational Site
      • Bratislava, Slovakia, 811 08
        • Novo Nordisk Investigational Site
      • Kosice, Slovakia, 040 01
        • Novo Nordisk Investigational Site
      • Lucenec, Slovakia, 98401
        • Novo Nordisk Investigational Site
      • Nitra, Slovakia, 94 911
        • Novo Nordisk Investigational Site
      • Presov, Slovakia, 080 01
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Novo Nordisk Investigational Site
    • Arizona
      • Goodyear, Arizona, United States, 85395
        • Novo Nordisk Investigational Site
      • Mesa, Arizona, United States, 85206
        • Novo Nordisk Investigational Site
      • Phoenix, Arizona, United States, 85018
        • Novo Nordisk Investigational Site
    • California
      • Concord, California, United States, 94520
        • Novo Nordisk Investigational Site
      • Encino, California, United States, 91436
        • Novo Nordisk Investigational Site
      • Fair Oaks, California, United States, 95628
        • Novo Nordisk Investigational Site
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
      • Greenbrae, California, United States, 94904
        • Novo Nordisk Investigational Site
      • Lancaster, California, United States, 93534
        • Novo Nordisk Investigational Site
      • Lomita, California, United States, 90717
        • Novo Nordisk Investigational Site
      • Long Beach, California, United States, 90806
        • Novo Nordisk Investigational Site
      • Montclair, California, United States, 91763
        • Novo Nordisk Investigational Site
      • Northridge, California, United States, 91325
        • Novo Nordisk Investigational Site
      • San Mateo, California, United States, 94401
        • Novo Nordisk Investigational Site
      • San Ramon, California, United States, 94583
        • Novo Nordisk Investigational Site
      • Tarzana, California, United States, 91356-3551
        • Novo Nordisk Investigational Site
      • Van Nuys, California, United States, 91405
        • Novo Nordisk Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Novo Nordisk Investigational Site
    • Florida
      • Bradenton, Florida, United States, 34201
        • Novo Nordisk Investigational Site
      • Fort Myers, Florida, United States, 33912-4343
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32204
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32207
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32258
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33156
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33135
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33136
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33155
        • Novo Nordisk Investigational Site
      • Miami Springs, Florida, United States, 33166
        • Novo Nordisk Investigational Site
      • Orlando, Florida, United States, 32806
        • Novo Nordisk Investigational Site
      • Plant City, Florida, United States, 33563
        • Novo Nordisk Investigational Site
      • Winter Haven, Florida, United States, 33880
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Novo Nordisk Investigational Site
    • Illinois
      • Arlington Heights, Illinois, United States, 60004-2315
        • Novo Nordisk Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Novo Nordisk Investigational Site
      • Troy, Michigan, United States, 48098
        • Novo Nordisk Investigational Site
    • Missouri
      • Saint Charles, Missouri, United States, 63303
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Novo Nordisk Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052-2649
        • Novo Nordisk Investigational Site
      • Las Vegas, Nevada, United States, 89128
        • Novo Nordisk Investigational Site
      • Reno, Nevada, United States, 89502-0111
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
        • Novo Nordisk Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Novo Nordisk Investigational Site
      • Flemington, New Jersey, United States, 08822-5763
        • Novo Nordisk Investigational Site
      • Hamilton, New Jersey, United States, 08619
        • Novo Nordisk Investigational Site
      • Lawrenceville, New Jersey, United States, 08648
        • Novo Nordisk Investigational Site
      • Toms River, New Jersey, United States, 08753-2975
        • Novo Nordisk Investigational Site
    • New York
      • Mineola, New York, United States, 11501
        • Novo Nordisk Investigational Site
      • North Massapequa, New York, United States, 11758-1802
        • Novo Nordisk Investigational Site
      • West Seneca, New York, United States, 14224
        • Novo Nordisk Investigational Site
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Novo Nordisk Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45439
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novo Nordisk Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15243
        • Novo Nordisk Investigational Site
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Novo Nordisk Investigational Site
      • Sumter, South Carolina, United States, 29150-1900
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
      • Jellico, Tennessee, United States, 37762
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
      • Nashville, Tennessee, United States, 37212
        • Novo Nordisk Investigational Site
      • Tullahoma, Tennessee, United States, 37388
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, United States, 76014
        • Novo Nordisk Investigational Site
      • Austin, Texas, United States, 78731
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75218
        • 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
      • Plano, Texas, United States, 75075
        • Novo Nordisk Investigational Site
      • Round Rock, Texas, United States, 78681
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78215
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78249
        • Novo Nordisk Investigational Site
      • Schertz, Texas, United States, 78154
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Novo Nordisk Investigational Site
    • Utah
      • Orem, Utah, United States, 84058
        • Novo Nordisk Investigational Site
      • Saint George, Utah, United States, 84790
        • Novo Nordisk Investigational Site
      • Salt Lake City, Utah, United States, 84107
        • Novo Nordisk Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23219
        • 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:

  • Subjects with type 2 diabetes mellitus
  • Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)
  • Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (Visit 1)
  • BMI (body mass index) equal to or below 40 kg/m^2

Exclusion Criteria:

  • Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (Visit 1)
  • Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor agonist) which in the Investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
  • Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
  • Screening calcitonin equal to or above 50 ng/l
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
  • Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures
  • Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion
  • Subjects with a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator may confound the results of the trial or pose additional risk in administering trial products
  • 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
  • Masking: NONE

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 + OADs
Drug: insulin degludec/liraglutide
Injected subcutaneously (under the skin) once daily. Dose individually adjusted. Subjects will continue their pre-trial OAD treatment without changing the frequency or dose throughout the trial.
ACTIVE_COMPARATOR: Liraglutide or exenatide + OADs
Drug: liraglutide
Subjects will continue on their pre-trial treatment of liraglutide (Victoza®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.
Drug: exenatide
Subjects will continue on their pre-trial treatment of exenatide (Byetta®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.

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
Time Frame
Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)
Time Frame: Week 0, week 26
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
Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
Time Frame: Week 26
Percentage of subjects achieving HbA1c below 7.0% after 26 weeks of treatment.
Week 26
Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Time Frame: Week 26
Percentage of responders achieving pre-defined target for HbA1c - HbA1c ≤ 6.5% (48 mmol/mol).
Week 26
Change From Baseline in Body Weight
Time Frame: Week 0, week 26
Mean change in body weight after 26 weeks of treatment.
Week 0, week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, week 26
Mean change in fasting plasma glucose from baseline, after 26 weeks of treatment.
Week 0, week 26
Number of Severe or Minor Hypoglycaemic Episodes
Time Frame: After 26 weeks of treatment
Rate (events per 100 patient years of exposure) of treatment-emergent confirmed hypoglycaemic episodes. The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes. Severe hypoglycaemia was categorised as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or PG <3.1 mmol/L (56 mg/dL), and which was handled by the subject himself/herself, or any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or PG value <3.1 mmol/L (56 mg/dL).
After 26 weeks of treatment
Number of Adverse Events (AEs)
Time Frame: After 26 weeks of treatment
Rate (events per 100 exposure years) of treatment-emergent adverse events (an event that had onset date (or an increase in severity) on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment) which occurred during the 26 weeks of treatment.
After 26 weeks of treatment
Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)
Time Frame: Week 0, week 26
The patient related outcome is calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total score are later transformed to a 0-100 scale for analysis. The mean change in scores from baseline to 26 weeks for all the individual sub domains and total scores are presented here.
Week 0, week 26
Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Time Frame: Week 0, week 26
Mean change in diabetes treatment satisfaction questionnaire (DTSQs) scores from baseline. The scores ranged from 0 to 6. Higher total score on a 0-6 point scale indicates a general higher treatment satisfaction, whereas higher score on perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia indicate that blood glucose levels are out of the target range.
Week 0, week 26

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.
August 29, 2012

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.
March 11, 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.
March 11, 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).
August 28, 2012

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.
August 29, 2012

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.
August 30, 2012

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.
  • NN9068-3851
  • 2012-000209-63 (EUDRACT_NUMBER)
  • U1111-1127-1321 (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.

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