A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT02501161
Last Updated: 2019-11-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1012 participants
INTERVENTIONAL
2016-01-31
2018-10-03
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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Insulin degludec/liraglutide QD + OAD(s)
insulin degludec/liraglutide
Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.
insulin glargine QD + OAD(s)
insulin glargine
Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.
Interventions
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insulin degludec/liraglutide
Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.
insulin glargine
Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.
Eligibility Criteria
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Inclusion Criteria
* Subjects diagnosed with type 2 diabetes mellitus
* HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis
* Body mass index greater than or equal to 20 kg/m\^2
* Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
* Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record)
* Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
Exclusion Criteria
* Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening
* Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal
* Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
* History of pancreatitis (acute or chronic)
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
Muscle Shoals, Alabama, United States
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Tuscumbia, Alabama, United States
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Glendale, Arizona, United States
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, 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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Monterey, California, United States
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Sacramento, California, United States
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Spring Valley, California, United States
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Ventura, California, United States
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Walnut Creek, California, United States
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Colorado Springs, Colorado, United States
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Boynton Beach, Florida, United States
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Lake Worth, Florida, United States
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Miami, Florida, United States
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Blackfoot, Idaho, United States
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Avon, Indiana, United States
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Indianapolis, Indiana, United States
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Metairie, Louisiana, United States
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Hyattsville, Maryland, United States
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Rockville, Maryland, United States
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Waltham, Massachusetts, United States
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Buckley, Michigan, United States
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Billings, Montana, United States
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Nashua, New Hampshire, United States
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Albuquerque, New Mexico, United States
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New Windsor, New York, United States
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Mason, Ohio, United States
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Maumee, Ohio, United States
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Beaver, Pennsylvania, United States
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Greer, South Carolina, United States
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Humboldt, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Katy, Texas, United States
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San Antonio, Texas, United States
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Midlothian, Virginia, United States
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Kenosha, Wisconsin, United States
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Kenosha, Wisconsin, United States
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Buenos Aires, , Argentina
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CABA, , Argentina
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Capital Federal, , Argentina
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Mendoza, , Argentina
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São Paulo, São Paulo, Brazil
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Porto Alegre, , Brazil
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Pilsen, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Budapest, , Hungary
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Budapest, , Hungary
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Dunaújváros, , Hungary
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Kaposvár, , Hungary
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Pécs, , Hungary
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Secunderabad, Andhra Pradesh, India
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Visakhapatnam, Andhra Pradesh, India
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Rohtak, Haryana, India
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Bangalore, Karnataka, India
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Mumbai, Maharashtra, India
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Nagpur, Maharashtra, India
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Pune, Maharashtra, India
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Pune, Maharashtra, India
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Delhi, New Delhi, India
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Jaipur, Rajasthan, India
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Coimbatore, Tamil Nadu, India
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Kolkata, West Bengal, India
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Kolkata, West Bengal, India
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Haifa, , Israel
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Haifa, , Israel
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Nahariya, , Israel
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Rishon LeZiyyon, , Israel
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Tel Aviv, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Ẕerifin, , Israel
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Bologna, , Italy
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Catanzaro, , Italy
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Cittadella (PD), , Italy
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Negrar (VR), , Italy
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Palermo, , Italy
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Pavia, , Italy
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Verona, , Italy
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Guadalajara, Jalisco, Mexico
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Cuernavaca, Morelos, Mexico
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Ciudad Madero, Tamaulipas, Mexico
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Durango, , Mexico
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Bodø, , Norway
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Hamar, , Norway
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Hoenefoss, , Norway
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Kløfta, , Norway
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Lierskogen, , Norway
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Oslo, , Norway
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Stavanger, , Norway
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Tananger, , Norway
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Bialystok, , Poland
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Gdansk, , Poland
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Zabrze, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Penza, , 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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Stavropol, , Russia
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Prievidza, , Slovakia
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Sabinov, , Slovakia
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Trebišov, , Slovakia
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Trenčín, , Slovakia
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Trnava, , Slovakia
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Cosmo City, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Durban, KwaZulu-Natal, South Africa
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eMkhomazi, KwaZulu-Natal, South Africa
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Brits, North West, South Africa
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Cape Town, Western Cape, South Africa
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Alberton, , South Africa
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Ankara, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Rize, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Angus, , United Kingdom
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Coventry, , United Kingdom
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Dudley, , United Kingdom
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Dundee, , United Kingdom
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Fife, , United Kingdom
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Hull, , United Kingdom
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Rotherham, , United Kingdom
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Torquay, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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References
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Aroda VR, Gonzalez-Galvez G, Gron R, Halladin N, Haluzik M, Jermendy G, Kok A, Orsy P, Sabbah M, Sesti G, Silver R. Durability of insulin degludec plus liraglutide versus insulin glargine U100 as initial injectable therapy in type 2 diabetes (DUAL VIII): a multicentre, open-label, phase 3b, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Aug;7(8):596-605. doi: 10.1016/S2213-8587(19)30184-6. Epub 2019 Jun 9.
Philis-Tsimikas A, Aroda VR, De Block C, Billings LK, Liebl A, Sivarathinasami R, D'Cruz JM, Lingvay I. Higher Derived Time in Range With IDegLira Versus Insulin Glargine U100 in People With Type 2 Diabetes. J Diabetes Sci Technol. 2024 May;18(3):653-659. doi: 10.1177/19322968221149041. Epub 2023 Jan 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2014-005639-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1165-3914
Identifier Type: OTHER
Identifier Source: secondary_id
NN9068-4228
Identifier Type: -
Identifier Source: org_study_id
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