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: March 11, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responders achieving pre-defined target: HbA1c below 7.0% (53 mmol/mol) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Responders achieving pre-defined target: HbA1c below or equal to 6.5% (48 mmol/mol) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of severe or minor hypoglycaemic episodes [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of adverse events (AEs) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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 Clinical Trial Call Center
Birmingham, Alabama, United States, 35216
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Goodyear, Arizona, United States, 85395
Novo Nordisk Clinical Trial Call Center
Phoenix, Arizona, United States, 85018
United States, California
Novo Nordisk Clinical Trial Call Center
Chino, California, United States, 91710
Novo Nordisk Clinical Trial Call Center
Fresno, California, United States, 93720
Novo Nordisk Clinical Trial Call Center
Greenbrae, California, United States, 94904
Novo Nordisk Clinical Trial Call Center
Lancaster, California, United States, 93534
Novo Nordisk Clinical Trial Call Center
Lomita, California, United States, 90717
Novo Nordisk Clinical Trial Call Center
Long Beach, California, United States, 90806
Novo Nordisk Clinical Trial Call Center
Northridge, California, United States, 91325
Novo Nordisk Clinical Trial Call Center
San Mateo, California, United States, 94401
Novo Nordisk Clinical Trial Call Center
Tarzana, California, United States, 91356-3551
Novo Nordisk Clinical Trial Call Center
West Hills, California, United States, 91307
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Colorado Springs, Colorado, United States, 80910
United States, Florida
Novo Nordisk Clinical Trial Call Center
Bradenton, Florida, United States, 34208
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, United States, 32258
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, United States, 32207
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33156
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33135-1687
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33136
Novo Nordisk Clinical Trial Call Center
Orlando, Florida, United States, 32806
Novo Nordisk Clinical Trial Call Center
Winter Haven, Florida, United States, 33880
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30318
Novo Nordisk Clinical Trial Call Center
Roswell, Georgia, United States, 30076
United States, Hawaii
Novo Nordisk Clinical Trial Call Center
Honolulu, Hawaii, United States, 96813
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Arlington Heights, Illinois, United States, 60004-2315
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Indianapolis, Indiana, United States, 46254
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Lexington, Kentucky, United States, 40503
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Rockville, Maryland, United States, 20852
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Kalamazoo, Michigan, United States, 49048
Novo Nordisk Clinical Trial Call Center
Troy, Michigan, United States, 48098
United States, Missouri
Novo Nordisk Clinical Trial Call Center
St. Charles, Missouri, United States, 63303
United States, Nebraska
Novo Nordisk Clinical Trial Call Center
Omaha, Nebraska, United States, 68124
United States, Nevada
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Berlin, New Jersey, United States, 08009
Novo Nordisk Clinical Trial Call Center
Hamilton, New Jersey, United States, 08619
Novo Nordisk Clinical Trial Call Center
Lawrenceville, New Jersey, United States, 08648
United States, New York
Novo Nordisk Clinical Trial Call Center
Mineola, New York, United States, 11501
Novo Nordisk Clinical Trial Call Center
North Massapequa, New York, United States, 11758-1802
Novo Nordisk Clinical Trial Call Center
West Seneca, New York, United States, 14224
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Morehead City, North Carolina, United States, 28557
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Dayton, Ohio, United States, 45439
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Altoona, Pennsylvania, United States, 16602-2415
Novo Nordisk Clinical Trial Call Center
Pittsburgh, Pennsylvania, United States, 15243
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Myrtle Beach, South Carolina, United States, 29572-4610
Novo Nordisk Clinical Trial Call Center
Sumter, South Carolina, United States, 29150-1900
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States, 37404
Novo Nordisk Clinical Trial Call Center
Johnson City, Tennessee, United States, 37604
Novo Nordisk Clinical Trial Call Center
Nashville, Tennessee, United States, 37212
Novo Nordisk Clinical Trial Call Center
Tullahoma, Tennessee, United States, 37388
United States, Texas
Novo Nordisk Clinical Trial Call Center
Arlington, Texas, United States, 76014
Novo Nordisk Clinical Trial Call Center
Austin, Texas, United States, 78731
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75231
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75218
Novo Nordisk Clinical Trial Call Center
Fort Worth, Texas, United States, 76113
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77074
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77095
Novo Nordisk Clinical Trial Call Center
Plano, Texas, United States, 75075
Novo Nordisk Clinical Trial Call Center
Round Rock, Texas, United States, 78681
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78215
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78249
Novo Nordisk Clinical Trial Call Center
Schertz, Texas, United States, 78154
Novo Nordisk Clinical Trial Call Center
Sugarland, Texas, United States, 77478
United States, Utah
Novo Nordisk Clinical Trial Call Center
Orem, Utah, United States, 84058
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, United States, 84107
Novo Nordisk Clinical Trial Call Center
St. George, Utah, United States, 84790
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Richmond, Virginia, United States, 23219
Australia, New South Wales
Coffs Harbour, New South Wales, Australia, 2450
France
LA ROCHELLE cedex, France, 17019
Narbonne, France, 11108
Sète, France, 34200
Hungary
Budapest, Hungary, 1042
Slovakia
Lucenec, Slovakia, 98401
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

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: March 11, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Slovakia: State Institute for Drug Control
United States: Food and Drug Administration
Hungary: Ministry of Health, Social and Family Affairs

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

ClinicalTrials.gov processed this record on September 30, 2014