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

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ClinicalTrials.gov Identifier: NCT01952145
Recruitment Status : Completed
First Posted : September 27, 2013
Results First Posted : January 20, 2017
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted globally. The aim of the trial is to compare the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec/liraglutide Drug: insulin glargine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 557 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus (DUAL™ V - Basal Insulin Switch)
Actual Study Start Date : September 20, 2013
Actual Primary Completion Date : November 4, 2014
Actual Study Completion Date : November 4, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin degludec/liraglutide OD plus metformin Drug: insulin degludec/liraglutide
Insulin degludec/liraglutide is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.

Active Comparator: Insulin glargine OD plus metformin Drug: insulin glargine
Insulin glargine is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.




Primary Outcome Measures :
  1. Change From Baseline in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 26 ]
    Change from baseline in HbA1c after 26 weeks of treatment


Secondary Outcome Measures :
  1. Change From Baseline in Body Weight [ Time Frame: Week 0, week 26 ]
    Change from baseline in body weight after 26 weeks of treatment

  2. Number of Treatment Emergent Confirmed Hypoglycaemic Episodes [ Time Frame: During 26 weeks of treatment ]
    Confirmed hypoglycaemic episodes were defined as either: Severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or an episode biochemically confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: - Type 2 diabetes mellitus - HbA1c 7.0-10.0% [53-86 mmol/mol] (both inclusive) by central laboratory analysis - Current treatment with insulin glargine for at least 90 days prior to screening - Stable daily dose of insulin glargine between 20 units and 50 units (both inclusive) for at least 56 days prior to screening. Total daily dose should be within the range of 20-50 units, both inclusive, on the day of screening, but individual fluctuations of plus/minus 10 procent within the 56 days prior to screening are acceptable - Stable daily dose of metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening - Body mass index (BMI) below or equal to 40 kg/m^2 Exclusion Criteria: - Any use of oral antidiabetic agents (OADs) (except for metformin) within 90 days prior to Visit 1 (screening) - Current use of any drug (except metformin and insulin glargine) or anticipated change inconcomitant medication, which in the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids) - Previous and/or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness includinggestational diabetes is allowed at the discretion of the investigator) - Previous and/or current treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide) - Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to 2.5 times upper normal range (UNR) - Impaired renal function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (1.4 mg/dL) for females, or as allowed according to local contraindications for metformin - 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) - History of chronic pancreatitis or idiopathic acute pancreatitis

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): NCT01952145


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Locations
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United States, California
Novo Nordisk Investigational Site
Fresno, California, United States, 93720
Novo Nordisk Investigational Site
Los Alamitos, California, United States, 90720
Novo Nordisk Investigational Site
Palm Springs, California, United States, 92262
Novo Nordisk Investigational Site
San Diego, California, United States, 92111
United States, Colorado
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80906
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80909
United States, Florida
Novo Nordisk Investigational Site
Bradenton, Florida, United States, 34201
Novo Nordisk Investigational Site
Fort Lauderdale, Florida, United States, 33316
Novo Nordisk Investigational Site
Miami, Florida, United States, 33165
Novo Nordisk Investigational Site
Pembroke Pines, Florida, United States, 33027
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33603
United States, Illinois
Novo Nordisk Investigational Site
Gurnee, Illinois, United States, 60031
United States, Indiana
Novo Nordisk Investigational Site
Evansville, Indiana, United States, 47725
Novo Nordisk Investigational Site
Michigan City, Indiana, United States, 46360
United States, Kentucky
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40503
Novo Nordisk Investigational Site
Louisville, Kentucky, United States, 40213
United States, Louisiana
Novo Nordisk Investigational Site
Slidell, Louisiana, United States, 70461-4231
United States, Missouri
Novo Nordisk Investigational Site
Saint Charles, Missouri, United States, 63303
United States, North Carolina
Novo Nordisk Investigational Site
Wilmington, North Carolina, United States, 28401
United States, Ohio
Novo Nordisk Investigational Site
Franklin, Ohio, United States, 45005
United States, Oklahoma
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novo Nordisk Investigational Site
Altoona, Pennsylvania, United States, 16602
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19140
United States, Tennessee
Novo Nordisk Investigational Site
Collierville, Tennessee, United States, 38017
Novo Nordisk Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-9302
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78224
United States, Utah
Novo Nordisk Investigational Site
West Jordan, Utah, United States, 84088-8871
United States, Washington
Novo Nordisk Investigational Site
Renton, Washington, United States, 98057
Novo Nordisk Investigational Site
Spokane, Washington, United States, 99218
Argentina
Novo Nordisk Investigational Site
Buenos Aires, Argentina, B1704ETD
Novo Nordisk Investigational Site
Capital Federal, Argentina, C1056ABJ
Novo Nordisk Investigational Site
Corrientes, Argentina, 3400
Novo Nordisk Investigational Site
Salta, Argentina, 4400
Novo Nordisk Investigational Site
Zarate, Argentina, B2800DGH
Australia, New South Wales
Novo Nordisk Investigational Site
Blacktown, New South Wales, Australia, 2148
Novo Nordisk Investigational Site
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Novo Nordisk Investigational Site
Herston, Queensland, Australia, 4029
Novo Nordisk Investigational Site
Ipswich, Queensland, Australia, 4305
Novo Nordisk Investigational Site
Robina, Queensland, Australia, 4226
Australia, Victoria
Novo Nordisk Investigational Site
East Ringwood, Victoria, Australia, 3135
Greece
Novo Nordisk Investigational Site
Athens, Greece, GR-11527
Novo Nordisk Investigational Site
Athens, Greece, GR-14233
Novo Nordisk Investigational Site
Ioannina, Greece, 45500
Novo Nordisk Investigational Site
Larissa, Greece, GR-41110
Novo Nordisk Investigational Site
Thessaloniki, Greece, GR-54642
Novo Nordisk Investigational Site
Thessaloniki, Greece, GR-56403
Novo Nordisk Investigational Site
Thessaloniki, Greece, GR-57001
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, H-1134
Novo Nordisk Investigational Site
Eger, Hungary, 3300
Novo Nordisk Investigational Site
Gyor, Hungary, 9024
Novo Nordisk Investigational Site
Gyula, Hungary, 5700
Novo Nordisk Investigational Site
Miskolc, Hungary, 3526
Mexico
Novo Nordisk Investigational Site
Pachuca, Hidalgo, Mexico, 42084
Novo Nordisk Investigational Site
Cuernavaca, Morelos, Mexico, 62250
Novo Nordisk Investigational Site
Mexico City, México, D.F., Mexico, 03300
Novo Nordisk Investigational Site
Durango, Mexico, 34000
Novo Nordisk Investigational Site
Monterrey, Mexico, 64460
Russian Federation
Novo Nordisk Investigational Site
Kazan, Russian Federation, 420073
Novo Nordisk Investigational Site
Kirov, Russian Federation, 610014
Novo Nordisk Investigational Site
Moscow, Russian Federation, 117036
Novo Nordisk Investigational Site
Moscow, Russian Federation, 123448
Novo Nordisk Investigational Site
Novosibirsk, Russian Federation, 630117
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 194358
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 199034
Novo Nordisk Investigational Site
St. Petersburg, Russian Federation, 194354
Novo Nordisk Investigational Site
Tomsk, Russian Federation, 634041
Novo Nordisk Investigational Site
Tomsk, Russian Federation, 634050
Novo Nordisk Investigational Site
Volgograd, Russian Federation, 400131
Novo Nordisk Investigational Site
Vsevolozhsk, Russian Federation, 188643
Slovakia
Novo Nordisk Investigational Site
Bardejov, Slovakia, 08501
Novo Nordisk Investigational Site
Dolny Kubin, Slovakia, 02601
Novo Nordisk Investigational Site
Kosice, Slovakia, 040 11
Novo Nordisk Investigational Site
Kosice, Slovakia, 04001
Novo Nordisk Investigational Site
Levice, Slovakia, 93401
Novo Nordisk Investigational Site
Lubochna, Slovakia, 03491
Novo Nordisk Investigational Site
Poprad, Slovakia, 05801
Novo Nordisk Investigational Site
Povazska Bystrica, Slovakia, 01701
Novo Nordisk Investigational Site
Prievidza, Slovakia, 97101
Novo Nordisk Investigational Site
Trnava, Slovakia, 91701
Novo Nordisk Investigational Site
Velky Meder, Slovakia, 93201
South Africa
Novo Nordisk Investigational Site
Midrand, Gauteng, South Africa, 1685
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4450
Novo Nordisk Investigational Site
Alberton, South Africa, 1449
Spain
Novo Nordisk Investigational Site
Almería, Spain, 04001
Novo Nordisk Investigational Site
Granada, Spain, 18012
Novo Nordisk Investigational Site
Palma de Mallorca, Spain, 07014
Novo Nordisk Investigational Site
Sevilla, Spain, 41003
Novo Nordisk Investigational Site
Sevilla, Spain, 41010
Novo Nordisk Investigational Site
Valencia, Spain, 46026
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01952145     History of Changes
Other Study ID Numbers: NN9068-3952
2012-004413-14 ( EudraCT Number )
U1111-1135-1003 ( Other Identifier: WHO )
First Posted: September 27, 2013    Key Record Dates
Results First Posted: January 20, 2017
Last Update Posted: January 3, 2019
Last Verified: December 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Insulin Glargine
Liraglutide
Insulin, Long-Acting
Xultophy
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists