A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes (DUAL™ II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01392573
First received: July 7, 2011
Last updated: August 14, 2014
Last verified: July 2014
  Purpose

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their pre-trial treatment with metformin throughout the entire trial.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec/liraglutide
Drug: insulin degludec
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: A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Change in body weight [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]

Enrollment: 414
Study Start Date: November 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDegLira + metformin
IDegLira was injected subcutaneously once daily for 26 weeks.
Drug: insulin degludec/liraglutide
IDeg/Lira treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDegLira is injected subcutaneously (under the skin) once daily.
Experimental: IDeg + metformin
IDeg was injected subcutaneously once daily for 26 weeks.
Drug: insulin degludec
IDeg treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDeg is 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
  • HbA1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive)
  • Subjects on stable daily doses for at least 90 days prior to trial start of: Basal insulin (total daily basal insulin dose within the range of 20-40U in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label)
  • BMI (Body Mass Index) more than or equal to 27 kg/m^2

Exclusion Criteria:

  • Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start
  • Impaired liver function
  • Impaired renal function
  • Screening calcitonin equal to or above 50 ng/l
  • Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
  • Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures
  • Severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg)
  • Acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion
  • 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: NCT01392573

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center
Huntsville, Alabama, United States, 35801
Novo Nordisk Clinical Trial Call Center
Vestavia, Alabama, United States, 35209
United States, California
Novo Nordisk Clinical Trial Call Center
Anaheim, California, United States, 92801
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90057
Novo Nordisk Clinical Trial Call Center
Tustin, California, United States, 92780
Novo Nordisk Clinical Trial Call Center
Ventura, California, United States, 93003-2824
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
Novo Nordisk Clinical Trial Call Center
Waterbury, Connecticut, United States, 06708
United States, Florida
Novo Nordisk Clinical Trial Call Center
Melbourne, Florida, United States, 32935
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Roswell, Georgia, United States, 30076
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Arlington Heights, Illinois, United States, 60004-2315
Novo Nordisk Clinical Trial Call Center
Avon, Illinois, United States, 46123
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60607
Novo Nordisk Clinical Trial Call Center
Crystal Lake, Illinois, United States, 60012
Novo Nordisk Clinical Trial Call Center
Gurnee, Illinois, United States, 60031
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Greenfield, Indiana, United States, 46140
Novo Nordisk Clinical Trial Call Center
Indianapolis, Indiana, United States, 46254
Novo Nordisk Clinical Trial Call Center
Muncie, Indiana, United States, 47304
Novo Nordisk Clinical Trial Call Center
New Albany, Indiana, United States, 47150
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Lexington, Kentucky, United States, 40503
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
Metairie, Louisiana, United States, 70006-2930
Novo Nordisk Clinical Trial Call Center
Metairie, Louisiana, United States, 70002
Novo Nordisk Clinical Trial Call Center
Slidell, Louisiana, United States, 70461-4231
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Rockville, Maryland, United States, 20852
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Methuen, Massachusetts, United States, 01844
Novo Nordisk Clinical Trial Call Center
Waltham, Massachusetts, United States, 02453
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Southfield, Michigan, United States, 48034-7661
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
Lawrenceville, New Jersey, United States, 08648
Novo Nordisk Clinical Trial Call Center
Toms River, New Jersey, United States, 08755-8050
United States, New York
Novo Nordisk Clinical Trial Call Center
Albany, New York, United States, 12206
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Asheboro, North Carolina, United States, 27203
Novo Nordisk Clinical Trial Call Center
Durham, North Carolina, United States, 27713
Novo Nordisk Clinical Trial Call Center
Greensboro, North Carolina, United States, 27408
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
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Greer, South Carolina, United States, 29651
Novo Nordisk Clinical Trial Call Center
Simpsonville, South Carolina, United States, 29681-1538
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Nashville, Tennessee, United States, 37203
United States, Texas
Novo Nordisk Clinical Trial Call Center
Austin, Texas, United States, 78731
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75246
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75251
Novo Nordisk Clinical Trial Call Center
Hurst, Texas, United States, 76054
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78229-6014
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78215
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78224
Novo Nordisk Clinical Trial Call Center
Sugarland, Texas, United States, 77478
United States, Utah
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, United States, 84107
Bulgaria
Haskovo, Bulgaria, 6300
Denmark
Hellerup, Denmark, 2900
Hungary
Debrecen, Hungary, 4043
India
Mumbai, Maharashtra, India, 400053
Slovenia
Novo mesto, Slovenia, 8000
Switzerland
St. Gallen, Switzerland, 9007
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: NCT01392573     History of Changes
Other Study ID Numbers: NN9068-3912, 2011-002336-72, U1111-1121-4897
Study First Received: July 7, 2011
Last Updated: August 14, 2014
Health Authority: Bulgaria: Ministry of Health
Denmark: Danish Medicines Agency
Hungary: Ministry of Health, Social and Family Affairs
India: Ministry of Health
Slovenia: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Switzerland: Swissmedic
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, Globin Zinc
Liraglutide
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 19, 2014