A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT02420262
Last Updated: 2018-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
506 participants
INTERVENTIONAL
2015-07-26
2016-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IDegLira
insulin degludec/liraglutide
Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
IGlar plus IAsp
insulin glargine
Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
insulin aspart
Injected s.c./subcutaneously (under the skin) before each main meal.
Interventions
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insulin degludec/liraglutide
Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
insulin glargine
Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
insulin aspart
Injected s.c./subcutaneously (under the skin) before each main meal.
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
* HbA1c (glycosylated haemoglobin) 7.0-10.0% \[53mmol/mol-86mmol/mol\] (both inclusive) by central laboratory analysis
* Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening
* Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
* Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening
* Body mass index (BMI) below or equal to 40 kg/m\^2
* Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
* Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times upper limit of normal
* Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m\^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
* Screening calcitonin at least 50 ng/L
* History of pancreatitis (acute or chronic)
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Tuscumbia, Alabama, United States
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Anaheim, California, United States
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Bermuda Dunes, California, United States
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Fresno, California, United States
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Lancaster, California, United States
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Lincoln, California, United States
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Lomita, California, United States
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Los Angeles, California, United States
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Montclair, California, United States
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Northridge, California, United States
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San Mateo, California, United States
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Ventura, California, United States
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Waterbury, Connecticut, United States
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Palm Harbor, Florida, United States
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Plantation, Florida, United States
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Blackfoot, Idaho, United States
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Chicago, Illinois, United States
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Skokie, Illinois, United States
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Indianapolis, Indiana, United States
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Metairie, Louisiana, United States
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Natchitoches, Louisiana, United States
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Shreveport, Louisiana, United States
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Rockville, Maryland, United States
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Waltham, Massachusetts, United States
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Billings, Montana, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Jackson Heights, New York, United States
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New Windsor, New York, United States
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West Seneca, New York, United States
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Shelby, North Carolina, United States
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Statesville, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Mason, Ohio, United States
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Altoona, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Greer, South Carolina, United States
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Murrells Inlet, South Carolina, United States
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Kingsport, Tennessee, United States
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Houston, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Sugar Land, Texas, United States
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Midlothian, Virginia, United States
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Spokane, Washington, United States
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CABA, , Argentina
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Capital Federal, , Argentina
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Córdoba, , Argentina
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Salta, , Argentina
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Brno, , Czechia
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Olomouc, Lazce, , Czechia
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Pardubice, , Czechia
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Prostějov, , Czechia
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Angers, , France
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Bourgoin, , France
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Brest, , France
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La Rochelle, , France
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Le Coudray, , France
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Le Creusot, , France
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Marseille, , France
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Marseille, , France
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Saint-Herblain, , France
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Saint-Priest-en-Jarez, , France
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Strasbourg, , France
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Vénissieux, , France
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Athens, , Greece
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Chalkida, Evia, , Greece
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Ioannina, , Greece
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Larissa, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Gyula, , Hungary
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Szeged, , Hungary
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Szombathely, , Hungary
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Tatabánya, , Hungary
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Haifa, , Israel
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Holon, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Nahariya, , Israel
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Rehovot, , Israel
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Guadalajara, Jalisco, Mexico
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Mexico City, México, D.F., Mexico
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Aguascalientes, , Mexico
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Durango, , Mexico
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Kazan', , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Volgograd, , Russia
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Bardejov, , Slovakia
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Dolný Kubín, , Slovakia
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Malacky, , Slovakia
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Poprad, , Slovakia
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Rožňava, , Slovakia
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Almería, , Spain
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Fuenlabrada - Madrid, , Spain
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Pozuelo de Alarcón, , Spain
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Seville, , Spain
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Seville, , Spain
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Valencia, , Spain
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Countries
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References
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Billings LK, Doshi A, Gouet D, Oviedo A, Rodbard HW, Tentolouris N, Gron R, Halladin N, Jodar E. Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin: The DUAL VII Randomized Clinical Trial. Diabetes Care. 2018 May;41(5):1009-1016. doi: 10.2337/dc17-1114. Epub 2018 Feb 26.
Billings LK, Agner BFR, Altuntas Y, Gron R, Halladin N, Klonoff DC, Tentolouris N, Jodar E. The Benefit of Insulin Degludec/Liraglutide (IDegLira) Compared With Basal-Bolus Insulin Therapy is Consistent Across Participant Subgroups With Type 2 Diabetes in the DUAL VII Randomized Trial. J Diabetes Sci Technol. 2021 May;15(3):636-645. doi: 10.1177/1932296820906888. Epub 2020 Feb 28.
Meneghini L, Doshi A, Gouet D, Vilsboll T, Begtrup K, Orsy P, Ranthe MF, Lingvay I. Insulin degludec/liraglutide (IDegLira) maintains glycaemic control and improves clinical outcomes, regardless of pre-trial insulin dose, in people with type 2 diabetes that is uncontrolled on basal insulin. Diabet Med. 2020 Feb;37(2):267-276. doi: 10.1111/dme.14178. Epub 2019 Nov 28.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2014-003621-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1160-6923
Identifier Type: OTHER
Identifier Source: secondary_id
REec-2015-1682
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN9068-4185
Identifier Type: -
Identifier Source: org_study_id
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