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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01676116
First received: August 28, 2012
Last updated: December 15, 2016
Last verified: December 2016
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec/liraglutide
Drug: liraglutide
Drug: exenatide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in glycosylated haemoglobin (HbA1c) from baseline (randomisation, Visit 2) [ Time Frame: Week 0, week 26 ]

Secondary Outcome Measures:
  • Responders achieving pre-defined target: HbA1c below 7.0% (53 mmol/mol) [ Time Frame: Week 26 ]
  • Responders achieving pre-defined target: HbA1c below or equal to 6.5% (48 mmol/mol) [ Time Frame: Week 26 ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 26 ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ]
  • Number of severe or minor hypoglycaemic episodes [ Time Frame: After 26 weeks of treatment ]
  • Number of adverse events (AEs) [ Time Frame: After 26 weeks of treatment ]
  • Change from baseline in patient reported outcomes (PROs) based on the treatment related impact measure - diabetes (TRIM-D) and diabetes treatment satisfaction questionnaire (DTSQ) [ Time Frame: Week 0, week 26 ]

Enrollment: 438
Study Start Date: August 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676116

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35216
United States, Arizona
Novo Nordisk Investigational Site
Goodyear, Arizona, United States, 85395
Novo Nordisk Investigational Site
Mesa, Arizona, United States, 85206
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85018
United States, California
Novo Nordisk Investigational Site
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
United States, Colorado
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80910
United States, Florida
Novo Nordisk Investigational Site
Bradenton, Florida, United States, 34201
Novo Nordisk Investigational Site
Fort Myers, Florida, United States, 33912-4343
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, 32216
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32258
Novo Nordisk Investigational Site
Miami Springs, Florida, United States, 33166
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, Florida, United States, 33156
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
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30318
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
United States, Hawaii
Novo Nordisk Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Illinois
Novo Nordisk Investigational Site
Arlington Heights, Illinois, United States, 60004-2315
United States, Indiana
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46254
United States, Kentucky
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40503
United States, Maryland
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Michigan
Novo Nordisk Investigational Site
Kalamazoo, Michigan, United States, 49048
Novo Nordisk Investigational Site
Troy, Michigan, United States, 48098
United States, Missouri
Novo Nordisk Investigational Site
St. Charles, Missouri, United States, 63303
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68124
United States, Nevada
Novo Nordisk Investigational Site
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
United States, New Hampshire
Novo Nordisk Investigational Site
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Novo Nordisk Investigational Site
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
United States, New York
Novo Nordisk Investigational Site
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
United States, North Carolina
Novo Nordisk Investigational Site
Morehead City, North Carolina, United States, 28557
United States, Ohio
Novo Nordisk Investigational Site
Columbus, Ohio, United States, 43214
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45439
United States, Pennsylvania
Novo Nordisk Investigational Site
Altoona, Pennsylvania, United States, 16602
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15243
United States, South Carolina
Novo Nordisk Investigational Site
Myrtle Beach, South Carolina, United States, 29572
Novo Nordisk Investigational Site
Sumter, South Carolina, United States, 29150-1900
United States, Tennessee
Novo Nordisk Investigational Site
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
United States, Texas
Novo Nordisk Investigational Site
Arlington, Texas, United States, 76014
Novo Nordisk Investigational Site
Austin, Texas, United States, 78731
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75218
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75231
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
United States, Utah
Novo Nordisk Investigational Site
Orem, Utah, United States, 84058
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84107
Novo Nordisk Investigational Site
St. George, Utah, United States, 84790
United States, Virginia
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23219
Australia, New South Wales
Novo Nordisk Investigational Site
Coffs Harbour, New South Wales, Australia, 2450
Novo Nordisk Investigational Site
Merewether, New South Wales, Australia, 2291
Australia, South Australia
Novo Nordisk Investigational Site
Keswick, South Australia, Australia, 5035
Australia, Victoria
Novo Nordisk Investigational Site
Box Hill, Victoria, Australia, 3128
Novo Nordisk Investigational Site
Melbourne, Victoria, Australia, 3004
France
Novo Nordisk Investigational Site
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
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1042
Novo Nordisk Investigational Site
Debrecen, Hungary, 4043
Novo Nordisk Investigational Site
Nyíregyhaza, Hungary, 4400
Novo Nordisk Investigational Site
Székesfehérvár, Hungary, 8000
Slovakia
Novo Nordisk Investigational Site
Bratislava, Slovakia, 811 08
Novo Nordisk Investigational Site
Bratislava, Slovakia, 831 01
Novo Nordisk Investigational Site
Bratislava, Slovakia, 851 01
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01676116     History of Changes
Other Study ID Numbers: NN9068-3851  2012-000209-63  U1111-1127-1321 
Study First Received: August 28, 2012
Last Updated: December 15, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Exenatide
Insulin
Liraglutide
Insulin, Long-Acting
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 17, 2017