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

NCT01952145 | Completed Phase 3 Results

• 3 other identifiers: NN9068-39522012-004413-14U1111-1135-1003
• Study Type: interventional
• Target: 557
• Locations: 10 countries
• Sites: 91

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c (Glycosylated Haemoglobin)

  Change from baseline in HbA1c after 26 weeks of treatment

  Week 0, week 26

Secondary Outcomes (2)

• Change From Baseline in Body Weight

  Week 0, week 26

• Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

  During 26 weeks of treatment

Study Arms (2)

Insulin degludec/liraglutide OD plus metformin

EXPERIMENTAL

Drug: insulin degludec/liraglutide

Insulin glargine OD plus metformin

ACTIVE COMPARATOR

Drug: insulin glargine

Interventions

insulin degludec/liraglutide DRUG

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.

Insulin degludec/liraglutide OD plus metformin

insulin glargine DRUG

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.

Insulin glargine OD plus metformin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (91)

Novo Nordisk Investigational Site

Fresno, California, 93720, United States

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Los Alamitos, California, 90720, United States

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Palm Springs, California, 92262, United States

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San Diego, California, 92111, United States

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Colorado Springs, Colorado, 80906, United States

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Colorado Springs, Colorado, 80909, United States

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Bradenton, Florida, 34201, United States

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Fort Lauderdale, Florida, 33316, United States

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Miami, Florida, 33165, United States

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Pembroke Pines, Florida, 33027, United States

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Tampa, Florida, 33603, United States

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Gurnee, Illinois, 60031, United States

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Evansville, Indiana, 47725, United States

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Michigan City, Indiana, 46360, United States

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Lexington, Kentucky, 40503, United States

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Louisville, Kentucky, 40213, United States

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Slidell, Louisiana, 70461-4231, United States

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Saint Charles, Missouri, 63303, United States

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Wilmington, North Carolina, 28401, United States

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Franklin, Ohio, 45005, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73104, United States

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Altoona, Pennsylvania, 16602, United States

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Philadelphia, Pennsylvania, 19140, United States

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Collierville, Tennessee, 38017, United States

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Kingsport, Tennessee, 37660, United States

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Dallas, Texas, 75390-9302, United States

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San Antonio, Texas, 78224, United States

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West Jordan, Utah, 84088-8871, United States

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Renton, Washington, 98057, United States

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Spokane, Washington, 99218, United States

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Buenos Aires, B1704ETD, Argentina

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Capital Federal, C1056ABJ, Argentina

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Corrientes, 3400, Argentina

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Salta, 4400, Argentina

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Zárate, B2800DGH, Argentina

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Blacktown, New South Wales, 2148, Australia

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Wollongong, New South Wales, 2500, Australia

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Herston, Queensland, 4029, Australia

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Ipswich, Queensland, 4305, Australia

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Robina, Queensland, 4226, Australia

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East Ringwood, Victoria, 3135, Australia

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Athens, GR-11527, Greece

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Athens, GR-14233, Greece

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Ioannina, 45500, Greece

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Larissa, GR-41110, Greece

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Thessaloniki, GR-54642, Greece

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Thessaloniki, GR-56403, Greece

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Thessaloniki, GR-57001, Greece

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Budapest, H-1134, Hungary

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Eger, 3300, Hungary

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Győr, 9024, Hungary

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Gyula, 5700, Hungary

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Miskolc, 3526, Hungary

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Pachuca, Hidalgo, 42084, Mexico

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Cuernavaca, Morelos, 62250, Mexico

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Mexico City, México, D.F., 03300, Mexico

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Durango, 34000, Mexico

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Monterrey, 64460, Mexico

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Kazan', 420073, Russia

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Kirov, 610014, Russia

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Moscow, 117036, Russia

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Moscow, 123448, Russia

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Novosibirsk, 630117, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 194358, Russia

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Saint Petersburg, 199034, Russia

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Tomsk, 634041, Russia

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Novo Nordisk Investigational Site

Tomsk, 634050, Russia

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Volgograd, 400131, Russia

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Vsevolozhsk, 188643, Russia

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Bardejov, 08501, Slovakia

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Dolný Kubín, 02601, Slovakia

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Košice, 040 11, Slovakia

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Košice, 04001, Slovakia

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Levice, 93401, Slovakia

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Ľubochňa, 03491, Slovakia

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Poprad, 05801, Slovakia

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Považská Bystrica, 01701, Slovakia

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Prievidza, 97101, Slovakia

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Trnava, 91701, Slovakia

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Veľký Meder, 93201, Slovakia

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Midrand, Gauteng, 1685, South Africa

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Durban, KwaZulu-Natal, 4450, South Africa

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Alberton, 1449, South Africa

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Almería, 04001, Spain

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Granada, 18012, Spain

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Palma de Mallorca, 07014, Spain

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Seville, 41003, Spain

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Seville, 41010, Spain

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Novo Nordisk Investigational Site

Valencia, 46026, Spain

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Related Publications (10)

• Lingvay I, Perez Manghi F, Garcia-Hernandez P, Norwood P, Lehmann L, Tarp-Johansen MJ, Buse JB; DUAL V Investigators. Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients With Uncontrolled Type 2 Diabetes: The DUAL V Randomized Clinical Trial. JAMA. 2016 Mar 1;315(9):898-907. doi: 10.1001/jama.2016.1252.

  PMID: 26934259 RESULT

• Hunt B, Mocarski M, Valentine WJ, Langer J. Evaluation of the long-term cost-effectiveness of IDegLira versus liraglutide added to basal insulin for patients with type 2 diabetes failing to achieve glycemic control on basal insulin in the USA. J Med Econ. 2017 Jul;20(7):663-670. doi: 10.1080/13696998.2017.1301943. Epub 2017 Mar 15.

  PMID: 28294641 RESULT

• Hunt B, Mocarski M, Valentine WJ, Langer J. Evaluation of the Short-Term Cost-Effectiveness of IDegLira Versus Continued Up-Titration of Insulin Glargine U100 in Patients with Type 2 Diabetes in the USA. Adv Ther. 2017 Apr;34(4):954-965. doi: 10.1007/s12325-017-0502-2. Epub 2017 Mar 9.

  PMID: 28281218 RESULT

• Norwood P, Chen R, Jaeckel E, Lingvay I, Jarlov H, Lehmann L, Heller S. Rates of hypoglycaemia are lower in patients treated with insulin degludec/liraglutide (IDegLira) than with IDeg or insulin glargine, regardless of the hypoglycaemia definition used. Diabetes Obes Metab. 2017 Nov;19(11):1562-1569. doi: 10.1111/dom.12972. Epub 2017 Jul 10.

  PMID: 28417535 RESULT

• Lingvay I, Harris S, Jaeckel E, Chandarana K, Ranthe MF, Jodar E. Insulin degludec/liraglutide (IDegLira) was effective across a range of dysglycaemia and body mass index categories in the DUAL V randomized trial. Diabetes Obes Metab. 2018 Jan;20(1):200-205. doi: 10.1111/dom.13043. Epub 2017 Jul 31.

  PMID: 28643425 RESULT

• Psota M, Psenkova MB, Racekova N, Ramirez de Arellano A, Vandebrouck T, Hunt B. Cost-effectiveness analysis of IDegLira versus basal-bolus insulin for patients with type 2 diabetes in the Slovak health system. Clinicoecon Outcomes Res. 2017 Dec 12;9:749-762. doi: 10.2147/CEOR.S143127. eCollection 2017.

  PMID: 29276398 RESULT

• Lingvay I, Handelsman Y, Linjawi S, Vilsboll T, Halladin N, Ranc K, Liebl A. EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES. Endocr Pract. 2019 Feb;25(2):144-155. doi: 10.4158/EP-2018-0284. Epub 2018 Nov 1.

  PMID: 30383495 RESULT

• Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

  PMID: 39963952 DERIVED

• 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.

  PMID: 36710452 DERIVED

• 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.

  PMID: 31705547 DERIVED

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

IDegLira; Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Global Clinical Registry (GCR, 1452)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 27, 2013
• Study Start: September 20, 2013
• Primary Completion: November 4, 2014
• Study Completion: November 4, 2014
• Last Updated: January 3, 2019
• Results First Posted: January 20, 2017

Record last verified: 2018-12

Locations

ZA (3); AR (5); GR (7); SL (11); AU (6); RU (12); ME (5); ES (6); HU (5); US (31)