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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 20, 2016
Last verified: December 2016
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]
    Change in HbA1c from baseline to 26 weeks.


Secondary Outcome Measures:
  • Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol) [ Time Frame: Week 26 ]
    Percentage of subjects having HbA1c below 7% at week 26.

  • Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol) [ Time Frame: Week 26 ]
    Percentage of subjects having HbA1c below 6.5% at week 26

  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ]
    Change from baseline in FPG at week 26.

  • Change From Baseline in Body Weight [ Time Frame: Week 0, week 26 ]
    Change from baseline in body weight at week 26.

  • Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes [ Time Frame: After 26 weeks of treatment ]

    An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration.

    Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor.

    Minor hypoglycaemic episodes were defined as:

    1. An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself.
    2. Any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or blood glucose value <2.8 mmol/L (50 mg/dL).

    Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

    Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE).


  • Number of Adverse Events (AEs) [ Time Frame: After 26 weeks of treatment ]
    An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE.


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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT01618162

  Hide Study Locations
Locations
United States, California
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801
Novo Nordisk Investigational Site
Garden Grove, California, United States, 92844
Novo Nordisk Investigational Site
La Jolla, California, United States, 92037
Novo Nordisk Investigational Site
Long Beach, California, United States, 90807
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90057
Novo Nordisk Investigational Site
San Mateo, California, United States, 94401
Novo Nordisk Investigational Site
Walnut Creek, California, United States, 94598
United States, Florida
Novo Nordisk Investigational Site
Kissimmee, Florida, United States, 34741
Novo Nordisk Investigational Site
Melbourne, Florida, United States, 32934
Novo Nordisk Investigational Site
Miami, Florida, United States, 33136
Novo Nordisk Investigational Site
Miami, Florida, United States, 33156
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30318
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
United States, Idaho
Novo Nordisk Investigational Site
Meridian, Idaho, United States, 83646
United States, Illinois
Novo Nordisk Investigational Site
Gurnee, Illinois, United States, 60031
United States, Kentucky
Novo Nordisk Investigational Site
Crestview Hills, Kentucky, United States, 41017-3464
United States, Maryland
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Michigan
Novo Nordisk Investigational Site
Troy, Michigan, United States, 48098
United States, Missouri
Novo Nordisk Investigational Site
Chesterfield, Missouri, United States, 63017
Novo Nordisk Investigational Site
St. Charles, Missouri, United States, 63303
United States, New Hampshire
Novo Nordisk Investigational Site
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Novo Nordisk Investigational Site
Lodi, New Jersey, United States, 076444
United States, New York
Novo Nordisk Investigational Site
West Seneca, New York, United States, 14224
United States, North Carolina
Novo Nordisk Investigational Site
Tabor City, North Carolina, United States, 28463
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45220-2213
Novo Nordisk Investigational Site
Franklin, Ohio, United States, 45005
Novo Nordisk Investigational Site
Mason, Ohio, United States, 45040-6815
United States, Oklahoma
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73104-5020
United States, Pennsylvania
Novo Nordisk Investigational Site
Beaver, Pennsylvania, United States, 15009
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19152
United States, South Carolina
Novo Nordisk Investigational Site
Greer, South Carolina, United States, 29651
Novo Nordisk Investigational Site
Pelzer, South Carolina, United States, 29669
Novo Nordisk Investigational Site
Simpsonville, South Carolina, United States, 29681
Novo Nordisk Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37404
Novo Nordisk Investigational Site
Kingsport, Tennessee, United States, 37660
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75203
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75251
Novo Nordisk Investigational Site
Hurst, Texas, United States, 76054
Novo Nordisk Investigational Site
Sugar Land, Texas, United States, 77478
United States, Utah
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Novo Nordisk Investigational Site
Newport News, Virginia, United States, 23606
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23219
Bulgaria
Novo Nordisk Investigational Site
Lukovit, Bulgaria, 5770
Novo Nordisk Investigational Site
Ruse, Bulgaria, 7000
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1324
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1431
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1606
Canada, British Columbia
Novo Nordisk Investigational Site
Burnaby, British Columbia, Canada, V5G 1T4
Novo Nordisk Investigational Site
Surrey, British Columbia, Canada, V3S 2N6
Novo Nordisk Investigational Site
Victoria, British Columbia, Canada, V8V 3N7
Canada, Ontario
Novo Nordisk Investigational Site
Cambridge, Ontario, Canada, N1R 7L6
Novo Nordisk Investigational Site
London, Ontario, Canada, N6G 2M1
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M4S 1Y2
Canada, Quebec
Novo Nordisk Investigational Site
Mirabel, Quebec, Canada, J7J 2K8
Novo Nordisk Investigational Site
Pointe Claire, Quebec, Canada, H9R 4S3
Novo Nordisk Investigational Site
Sherbrooke, Quebec, Canada, J1G 5K2
Canada
Novo Nordisk Investigational Site
Quebec, Canada, G1N 4V3
Germany
Novo Nordisk Investigational Site
Esslingen, Germany, 73728
Novo Nordisk Investigational Site
Hamburg, Germany, 22607
Novo Nordisk Investigational Site
Hohenmölsen, Germany, 06679
Novo Nordisk Investigational Site
Münster, Germany, 48145
Novo Nordisk Investigational Site
Pohlheim, Germany, 35415
Novo Nordisk Investigational Site
Rehlingen-Siersburg, Germany, 66780
Novo Nordisk Investigational Site
Sulzbach-Rosenberg, Germany, 92237
India
Novo Nordisk Investigational Site
Guwahati, Assam, India, 781007
Novo Nordisk Investigational Site
Guwahati, Assam, India
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, 560043
Novo Nordisk Investigational Site
Belgaum, Karnataka, India, 590001
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400008
Novo Nordisk Investigational Site
Pune, Maharashtra, India, 411030
Novo Nordisk Investigational Site
Delhi, New Delhi, India, 110002
Novo Nordisk Investigational Site
Hyderabad, India, 600034
Israel
Novo Nordisk Investigational Site
Haifa, Israel, 35152
Novo Nordisk Investigational Site
Holon, Israel, 58100
Novo Nordisk Investigational Site
Jerusalem, Israel, 91120
Novo Nordisk Investigational Site
Kfar Saba, Israel, 44281
Novo Nordisk Investigational Site
Petah-Tikva, Israel, 49100
Novo Nordisk Investigational Site
Tel Hashomer, Israel, 52621
Novo Nordisk Investigational Site
Tel-Aviv, Israel, 64239
Puerto Rico
Novo Nordisk Investigational Site
Manati, Puerto Rico, 00674
Turkey
Novo Nordisk Investigational Site
Ankara, Turkey, 06110
Novo Nordisk Investigational Site
Antalya, Turkey, 07058
Novo Nordisk Investigational Site
Gaziantep, Turkey, 27070
Novo Nordisk Investigational Site
Istanbul, Turkey, 34752
Novo Nordisk Investigational Site
Izmir, Turkey, 35100
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: NCT01618162     History of Changes
Other Study ID Numbers: NN9068-3951
2012-000140-97 ( EudraCT Number )
U1111-1126-9776 ( Other Identifier: WHO )
Study First Received: June 11, 2012
Results First Received: December 20, 2016
Last Updated: December 20, 2016

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

ClinicalTrials.gov processed this record on April 24, 2017