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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:
ClinicalTrials.gov Identifier:
NCT01392573
First Posted: July 12, 2011
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    Observed mean change from baseline in HbA1c after 26 Weeks of treatment.


Secondary Outcome Measures:
  • Change in Body Weight [ Time Frame: Week 0, week 26 ]
    Observed mean change from baseline in body weight after 26 Weeks of treatment.


Enrollment: 413
Actual Study Start Date: November 28, 2011
Study Completion Date: October 4, 2012
Primary Completion Date: October 1, 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

Information from the National Library of Medicine

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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
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392573


  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Investigational Site
Huntsville, Alabama, United States, 35801
Novo Nordisk Investigational Site
Vestavia Hills, Alabama, United States, 35209
United States, California
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90057
Novo Nordisk Investigational Site
Tustin, California, United States, 92780
Novo Nordisk Investigational Site
Ventura, California, United States, 93003
United States, Colorado
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
Novo Nordisk Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Florida
Novo Nordisk Investigational Site
Melbourne, Florida, United States, 32934
Novo Nordisk Investigational Site
Miami, Florida, United States, 33156
United States, Georgia
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
United States, Illinois
Novo Nordisk Investigational Site
Arlington Heights, Illinois, United States, 60004-2315
Novo Nordisk Investigational Site
Avon, Illinois, United States, 46123
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60607
Novo Nordisk Investigational Site
Crystal Lake, Illinois, United States, 60012
Novo Nordisk Investigational Site
Gurnee, Illinois, United States, 60031
United States, Indiana
Novo Nordisk Investigational Site
Greenfield, Indiana, United States, 46140
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46254
Novo Nordisk Investigational Site
Muncie, Indiana, United States, 47304
Novo Nordisk Investigational Site
New Albany, Indiana, United States, 47150
United States, Kentucky
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40503
United States, Louisiana
Novo Nordisk Investigational Site
Metairie, Louisiana, United States, 70002
Novo Nordisk Investigational Site
Metairie, Louisiana, United States, 70006-2930
Novo Nordisk Investigational Site
Slidell, Louisiana, United States, 70461-4231
United States, Maryland
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Massachusetts
Novo Nordisk Investigational Site
Methuen, Massachusetts, United States, 01844
Novo Nordisk Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Novo Nordisk Investigational Site
Waltham, Massachusetts, United States, 02453
United States, Michigan
Novo Nordisk Investigational Site
Southfield, Michigan, United States, 48034-7661
United States, Missouri
Novo Nordisk Investigational Site
Chesterfield, Missouri, United States, 63017
Novo Nordisk Investigational Site
Saint 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
Lawrenceville, New Jersey, United States, 08648
Novo Nordisk Investigational Site
Toms River, New Jersey, United States, 08755-8050
United States, New York
Novo Nordisk Investigational Site
Albany, New York, United States, 12206
Novo Nordisk Investigational Site
Smithtown, New York, United States, 11787
United States, North Carolina
Novo Nordisk Investigational Site
Asheboro, North Carolina, United States, 27203
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States, 27517
Novo Nordisk Investigational Site
Greensboro, North Carolina, United States, 27408
Novo Nordisk Investigational Site
Hickory, North Carolina, United States, 28602
Novo Nordisk Investigational Site
Statesville, North Carolina, United States, 28625
United States, Pennsylvania
Novo Nordisk Investigational Site
Beaver, Pennsylvania, United States, 15009
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107
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
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Novo Nordisk Investigational Site
Arlington, Texas, United States, 76014
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75246
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75251
Novo Nordisk Investigational Site
Hurst, Texas, United States, 76054
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, 78224
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78229
Novo Nordisk Investigational Site
Sugar Land, Texas, United States, 77478
United States, Utah
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84107
Bulgaria
Novo Nordisk Investigational Site
Burgas, Bulgaria, 8000
Novo Nordisk Investigational Site
Haskovo, Bulgaria, 6300
Novo Nordisk Investigational Site
Lukovit, Bulgaria, 5770
Novo Nordisk Investigational Site
Plovdiv, Bulgaria, 4001
Novo Nordisk Investigational Site
Ruse, Bulgaria, 7000
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1712
Denmark
Novo Nordisk Investigational Site
Gentofte, Denmark, 2820
Novo Nordisk Investigational Site
Hellerup, Denmark, 2900
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1125
Novo Nordisk Investigational Site
Debrecen, Hungary, 4043
Novo Nordisk Investigational Site
Eger, Hungary, H-3300
Novo Nordisk Investigational Site
Szombathely, Hungary, H-9700
India
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400008
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400053
Novo Nordisk Investigational Site
Pune, Maharashtra, India, 411001.
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600086
Novo Nordisk Investigational Site
Kolkata, West Bengal, India, 700064
Novo Nordisk Investigational Site
Dhantoli, Nagpur, India, 440012
Slovenia
Novo Nordisk Investigational Site
Koper, Slovenia, SI-6000
Novo Nordisk Investigational Site
Ljubljana, Slovenia, 1525
Novo Nordisk Investigational Site
Novo mesto, Slovenia, 8000
Switzerland
Novo Nordisk Investigational Site
Basel, Switzerland, 4031
Novo Nordisk Investigational Site
Bern, Switzerland, 3010
Novo Nordisk Investigational Site
Interlaken-Unterseen, Switzerland, 3800
Novo Nordisk Investigational Site
Lausanne, Switzerland, 1011
Novo Nordisk Investigational Site
Luzern 16, Switzerland, 6000
Novo Nordisk Investigational Site
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:
Publications:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01392573     History of Changes
Other Study ID Numbers: NN9068-3912
2011-002336-72 ( EudraCT Number )
U1111-1121-4897 ( Other Identifier: WHO )
First Submitted: July 7, 2011
First Posted: July 12, 2011
Results First Submitted: November 23, 2016
Results First Posted: January 20, 2017
Last Update Posted: October 27, 2017
Last Verified: September 2017

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