The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy (DUAL™IV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01618162
First received: June 11, 2012
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in glycosylated haemoglobin (HbA1c) [ 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 fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ 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 ]

Enrollment: 435
Study Start Date: August 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin degludec/liraglutide Drug: insulin degludec/liraglutide
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Placebo Comparator: Placebo Drug: placebo
Injected subcutaneously (under the skin) once daily.

  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
  • HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)
  • Subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)
  • Body Mass Index (BMI) below or equal to 40 kg/m^2

Exclusion Criteria:

  • Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in combinationwith metformin) below or equal to 90 days prior to screening visit (Visit 1)
  • Use of any drug (other than SU in monotherapy or in combination with metformin), which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
  • Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. exenatide, liraglutide)
  • 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 above or equal to 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 clinical 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 product
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618162

  Hide Study Locations
Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Anaheim, California, United States, 92801
Novo Nordisk Clinical Trial Call Center
La Jolla, California, United States, 92037
Novo Nordisk Clinical Trial Call Center
Long Beach, California, United States, 90807
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90057
Novo Nordisk Clinical Trial Call Center
San Mateo, California, United States, 94401
Novo Nordisk Clinical Trial Call Center
Walnut Creek, California, United States, 94598
United States, Florida
Novo Nordisk Clinical Trial Call Center
Kissimmee, Florida, United States, 34741
Novo Nordisk Clinical Trial Call Center
Melbourne, Florida, United States, 32935
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33156
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33136
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30318
Novo Nordisk Clinical Trial Call Center
Roswell, Georgia, United States, 30076-2126
United States, Idaho
Novo Nordisk Clinical Trial Call Center
Meridian, Idaho, United States, 83646
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Gurnee, Illinois, United States, 60031
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Rockville, Maryland, United States, 20852
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Troy, Michigan, United States, 48098
United States, Missouri
Novo Nordisk Clinical Trial Call Center
Chesterfield, Missouri, United States, 63017
Novo Nordisk Clinical Trial Call Center
St. Charles, Missouri, United States, 63303
United States, New Hampshire
Novo Nordisk Clinical Trial Call Center
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Lodi, New Jersey, United States, 076444
United States, New York
Novo Nordisk Clinical Trial Call Center
West Seneca, New York, United States, 14224
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Franklin, Ohio, United States, 45005
Novo Nordisk Clinical Trial Call Center
Mason, Ohio, United States, 45040-6815
United States, Oklahoma
Novo Nordisk Clinical Trial Call Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Beaver, Pennsylvania, United States, 15009
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19152
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Greer, South Carolina, United States, 29651
Novo Nordisk Clinical Trial Call Center
Pelzer, South Carolina, United States, 29669
Novo Nordisk Clinical Trial Call Center
Simpsonville, South Carolina, United States, 29681
Novo Nordisk Clinical Trial Call Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Brentwood, Tennessee, United States, 37027
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States, 37404
Novo Nordisk Clinical Trial Call Center
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75251
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75203
Novo Nordisk Clinical Trial Call Center
Hurst, Texas, United States, 76054
United States, Utah
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, United States, 84107
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia, United States, 23502
Bulgaria
Sofia, Bulgaria, 1606
Canada, Ontario
Cambridge, Ontario, Canada, N1R 7L6
Germany
Hamburg, Germany, 22607
India
Mumbai, Maharashtra, India, 400008
Israel
Jerusalem, Israel, 91240
Puerto Rico
Novo Nordisk Clinical Trial Call Center
Manati, Puerto Rico, 00674
Turkey
Gaziantep, Turkey, 27070
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: NCT01618162     History of Changes
Other Study ID Numbers: NN9068-3951, 2012-000140-97, U1111-1126-9776
Study First Received: June 11, 2012
Last Updated: December 3, 2013
Health Authority: Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
India: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Turkey: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014