- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01676116
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
438
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
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New South Wales
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Coffs Harbour, New South Wales, Australia, 2450
- Novo Nordisk Investigational Site
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Merewether, New South Wales, Australia, 2291
- Novo Nordisk Investigational Site
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South Australia
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Keswick, South Australia, Australia, 5035
- Novo Nordisk Investigational Site
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Victoria
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Box Hill, Victoria, Australia, 3128
- Novo Nordisk Investigational Site
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Melbourne, Victoria, Australia, 3004
- Novo Nordisk Investigational Site
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Antibes, France, 06600
- Novo Nordisk Investigational Site
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Boulogne Billancourt, France, 92100
- Novo Nordisk Investigational Site
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LA ROCHELLE cedex, France, 17019
- Novo Nordisk Investigational Site
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Montigny-les-Metz, France, 57950
- Novo Nordisk Investigational Site
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Narbonne, France, 11108
- Novo Nordisk Investigational Site
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Nimes, France, 30006
- Novo Nordisk Investigational Site
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Sète, France, 34200
- Novo Nordisk Investigational Site
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Venissieux, France, 69200
- Novo Nordisk Investigational Site
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Budapest, Hungary, 1042
- Novo Nordisk Investigational Site
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Debrecen, Hungary, 4043
- Novo Nordisk Investigational Site
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Nyíregyhaza, Hungary, 4400
- Novo Nordisk Investigational Site
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Székesfehérvár, Hungary, 8000
- Novo Nordisk Investigational Site
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Bratislava, Slovakia, 851 01
- Novo Nordisk Investigational Site
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Bratislava, Slovakia, 831 01
- Novo Nordisk Investigational Site
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Bratislava, Slovakia, 811 08
- Novo Nordisk Investigational Site
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Kosice, Slovakia, 040 01
- Novo Nordisk Investigational Site
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Lucenec, Slovakia, 98401
- Novo Nordisk Investigational Site
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Nitra, Slovakia, 94 911
- Novo Nordisk Investigational Site
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Presov, Slovakia, 080 01
- Novo Nordisk Investigational Site
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Alabama
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Birmingham, Alabama, United States, 35216
- Novo Nordisk Investigational Site
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Arizona
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Goodyear, Arizona, United States, 85395
- Novo Nordisk Investigational Site
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Mesa, Arizona, United States, 85206
- Novo Nordisk Investigational Site
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Phoenix, Arizona, United States, 85018
- Novo Nordisk Investigational Site
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California
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Concord, California, United States, 94520
- Novo Nordisk Investigational Site
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Encino, California, United States, 91436
- Novo Nordisk Investigational Site
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Fair Oaks, California, United States, 95628
- Novo Nordisk Investigational Site
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Fresno, California, United States, 93720
- Novo Nordisk Investigational Site
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Greenbrae, California, United States, 94904
- Novo Nordisk Investigational Site
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Lancaster, California, United States, 93534
- Novo Nordisk Investigational Site
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Lomita, California, United States, 90717
- Novo Nordisk Investigational Site
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Long Beach, California, United States, 90806
- Novo Nordisk Investigational Site
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Montclair, California, United States, 91763
- Novo Nordisk Investigational Site
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Northridge, California, United States, 91325
- Novo Nordisk Investigational Site
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San Mateo, California, United States, 94401
- Novo Nordisk Investigational Site
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San Ramon, California, United States, 94583
- Novo Nordisk Investigational Site
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Tarzana, California, United States, 91356-3551
- Novo Nordisk Investigational Site
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Van Nuys, California, United States, 91405
- Novo Nordisk Investigational Site
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Colorado
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Colorado Springs, Colorado, United States, 80910
- Novo Nordisk Investigational Site
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Florida
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Bradenton, Florida, United States, 34201
- Novo Nordisk Investigational Site
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Fort Myers, Florida, United States, 33912-4343
- Novo Nordisk Investigational Site
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Jacksonville, Florida, United States, 32216
- Novo Nordisk Investigational Site
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Jacksonville, Florida, United States, 32204
- Novo Nordisk Investigational Site
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Jacksonville, Florida, United States, 32207
- Novo Nordisk Investigational Site
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Jacksonville, Florida, United States, 32258
- Novo Nordisk Investigational Site
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Miami, Florida, United States, 33156
- Novo Nordisk Investigational Site
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Miami, Florida, United States, 33135
- Novo Nordisk Investigational Site
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Miami, Florida, United States, 33136
- Novo Nordisk Investigational Site
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Miami, Florida, United States, 33155
- Novo Nordisk Investigational Site
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Miami Springs, Florida, United States, 33166
- Novo Nordisk Investigational Site
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Orlando, Florida, United States, 32806
- Novo Nordisk Investigational Site
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Plant City, Florida, United States, 33563
- Novo Nordisk Investigational Site
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Winter Haven, Florida, United States, 33880
- Novo Nordisk Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30318
- Novo Nordisk Investigational Site
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Roswell, Georgia, United States, 30076
- Novo Nordisk Investigational Site
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Hawaii
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Honolulu, Hawaii, United States, 96814
- Novo Nordisk Investigational Site
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Illinois
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Arlington Heights, Illinois, United States, 60004-2315
- Novo Nordisk Investigational Site
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Indiana
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Indianapolis, Indiana, United States, 46254
- Novo Nordisk Investigational Site
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Kentucky
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Lexington, Kentucky, United States, 40503
- Novo Nordisk Investigational Site
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Maryland
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Rockville, Maryland, United States, 20852
- Novo Nordisk Investigational Site
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Michigan
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Kalamazoo, Michigan, United States, 49048
- Novo Nordisk Investigational Site
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Troy, Michigan, United States, 48098
- Novo Nordisk Investigational Site
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Missouri
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Saint Charles, Missouri, United States, 63303
- Novo Nordisk Investigational Site
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Nebraska
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Omaha, Nebraska, United States, 68124
- Novo Nordisk Investigational Site
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Nevada
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Henderson, Nevada, United States, 89052-2649
- Novo Nordisk Investigational Site
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Las Vegas, Nevada, United States, 89128
- Novo Nordisk Investigational Site
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Reno, Nevada, United States, 89502-0111
- Novo Nordisk Investigational Site
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New Hampshire
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Nashua, New Hampshire, United States, 03063
- Novo Nordisk Investigational Site
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New Jersey
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Berlin, New Jersey, United States, 08009
- Novo Nordisk Investigational Site
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Flemington, New Jersey, United States, 08822-5763
- Novo Nordisk Investigational Site
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Hamilton, New Jersey, United States, 08619
- Novo Nordisk Investigational Site
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Lawrenceville, New Jersey, United States, 08648
- Novo Nordisk Investigational Site
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Toms River, New Jersey, United States, 08753-2975
- Novo Nordisk Investigational Site
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New York
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Mineola, New York, United States, 11501
- Novo Nordisk Investigational Site
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North Massapequa, New York, United States, 11758-1802
- Novo Nordisk Investigational Site
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West Seneca, New York, United States, 14224
- Novo Nordisk Investigational Site
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North Carolina
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Morehead City, North Carolina, United States, 28557
- Novo Nordisk Investigational Site
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Ohio
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Columbus, Ohio, United States, 43214
- Novo Nordisk Investigational Site
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Dayton, Ohio, United States, 45439
- Novo Nordisk Investigational Site
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Pennsylvania
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Altoona, Pennsylvania, United States, 16602
- Novo Nordisk Investigational Site
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Pittsburgh, Pennsylvania, United States, 15243
- Novo Nordisk Investigational Site
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
- Novo Nordisk Investigational Site
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Sumter, South Carolina, United States, 29150-1900
- Novo Nordisk Investigational Site
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Novo Nordisk Investigational Site
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Jellico, Tennessee, United States, 37762
- Novo Nordisk Investigational Site
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Kingsport, Tennessee, United States, 37660
- Novo Nordisk Investigational Site
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Nashville, Tennessee, United States, 37212
- Novo Nordisk Investigational Site
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Tullahoma, Tennessee, United States, 37388
- Novo Nordisk Investigational Site
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Texas
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Arlington, Texas, United States, 76014
- Novo Nordisk Investigational Site
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Austin, Texas, United States, 78731
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75231
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75218
- Novo Nordisk Investigational Site
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Fort Worth, Texas, United States, 76113
- Novo Nordisk Investigational Site
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Houston, Texas, United States, 77074
- Novo Nordisk Investigational Site
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Houston, Texas, United States, 77095
- Novo Nordisk Investigational Site
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Plano, Texas, United States, 75075
- Novo Nordisk Investigational Site
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Round Rock, Texas, United States, 78681
- Novo Nordisk Investigational Site
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San Antonio, Texas, United States, 78215
- Novo Nordisk Investigational Site
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San Antonio, Texas, United States, 78249
- Novo Nordisk Investigational Site
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Schertz, Texas, United States, 78154
- Novo Nordisk Investigational Site
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Sugar Land, Texas, United States, 77478
- Novo Nordisk Investigational Site
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Utah
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Orem, Utah, United States, 84058
- Novo Nordisk Investigational Site
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Saint George, Utah, United States, 84790
- Novo Nordisk Investigational Site
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Salt Lake City, Utah, United States, 84107
- Novo Nordisk Investigational Site
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Virginia
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Richmond, Virginia, United States, 23219
- Novo Nordisk Investigational Site
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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:
- 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 |
Intervention / Treatment |
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EXPERIMENTAL: Insulin degludec/liraglutide + OADs
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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.
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ACTIVE_COMPARATOR: Liraglutide or exenatide + OADs
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)
Time Frame: Week 0, week 26
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Week 0, week 26
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
Time Frame: Week 26
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Percentage of subjects achieving HbA1c below 7.0% after 26 weeks of treatment.
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Week 26
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Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Time Frame: Week 26
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Percentage of responders achieving pre-defined target for HbA1c - HbA1c ≤ 6.5% (48 mmol/mol).
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Week 26
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Change From Baseline in Body Weight
Time Frame: Week 0, week 26
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Mean change in body weight after 26 weeks of treatment.
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Week 0, week 26
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Change From Baseline in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, week 26
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Mean change in fasting plasma glucose from baseline, after 26 weeks of treatment.
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Week 0, week 26
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Number of Severe or Minor Hypoglycaemic Episodes
Time Frame: After 26 weeks of treatment
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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).
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After 26 weeks of treatment
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Number of Adverse Events (AEs)
Time Frame: After 26 weeks of treatment
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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.
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After 26 weeks of treatment
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Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)
Time Frame: Week 0, week 26
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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.
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Week 0, week 26
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Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Time Frame: Week 0, week 26
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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.
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Week 0, week 26
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Linjawi S, Bode BW, Chaykin LB, Courreges JP, Handelsman Y, Lehmann LM, Mishra A, Simpson RW. The Efficacy of IDegLira (Insulin Degludec/Liraglutide Combination) in Adults with Type 2 Diabetes Inadequately Controlled with a GLP-1 Receptor Agonist and Oral Therapy: DUAL III Randomized Clinical Trial. Diabetes Ther. 2017 Feb;8(1):101-114. doi: 10.1007/s13300-016-0218-3. Epub 2016 Dec 10.
- Lingvay I, Handelsman Y, Linjawi S, Vilsboll T, Halladin N, Ranc K, Liebl A. EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES. Endocr Pract. 2019 Feb;25(2):144-155. doi: 10.4158/EP-2018-0284. Epub 2018 Nov 1.
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)
August 29, 2012
Primary Completion (ACTUAL)
March 11, 2014
Study Completion (ACTUAL)
March 11, 2014
Study Registration Dates
First Submitted
August 28, 2012
First Submitted That Met QC Criteria
August 29, 2012
First Posted (ESTIMATE)
August 30, 2012
Study Record Updates
Last Update Posted (ACTUAL)
January 3, 2019
Last Update Submitted That Met QC Criteria
December 7, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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