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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

NCT ID: NCT01952145

Last Updated: 2019-01-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

557 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-20

Study Completion Date

2014-11-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin degludec/liraglutide OD plus metformin

Group Type EXPERIMENTAL

insulin degludec/liraglutide

Intervention Type 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 glargine OD plus metformin

Group Type ACTIVE_COMPARATOR

insulin glargine

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Fresno, California, United States

Site Status

Novo Nordisk Investigational Site

Los Alamitos, California, United States

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Novo Nordisk Investigational Site

Palm Springs, California, United States

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San Diego, California, United States

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Colorado Springs, Colorado, United States

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Colorado Springs, Colorado, United States

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Bradenton, Florida, United States

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Fort Lauderdale, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Gurnee, Illinois, United States

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Evansville, Indiana, United States

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Michigan City, Indiana, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Slidell, Louisiana, United States

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Saint Charles, Missouri, United States

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Wilmington, North Carolina, United States

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Franklin, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Altoona, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Collierville, Tennessee, United States

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Kingsport, Tennessee, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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West Jordan, Utah, United States

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Renton, Washington, United States

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Spokane, Washington, United States

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Buenos Aires, , Argentina

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Capital Federal, , Argentina

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Corrientes, , Argentina

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Salta, , Argentina

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Zárate, , Argentina

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Blacktown, New South Wales, Australia

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Wollongong, New South Wales, Australia

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Herston, Queensland, Australia

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Ipswich, Queensland, Australia

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Robina, Queensland, Australia

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East Ringwood, Victoria, Australia

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Athens, , Greece

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Athens, , 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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Thessaloniki, , Greece

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Budapest, , Hungary

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Eger, , Hungary

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Győr, , Hungary

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Gyula, , Hungary

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Miskolc, , Hungary

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Pachuca, Hidalgo, Mexico

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Cuernavaca, Morelos, Mexico

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Mexico City, México, D.F., Mexico

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Durango, , Mexico

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Monterrey, , Mexico

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Kazan', , Russia

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Kirov, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Novosibirsk, , 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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Tomsk, , Russia

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Tomsk, , Russia

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Volgograd, , Russia

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Vsevolozhsk, , Russia

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Bardejov, , Slovakia

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Dolný Kubín, , Slovakia

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Košice, , Slovakia

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Košice, , Slovakia

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Levice, , Slovakia

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Ľubochňa, , Slovakia

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Poprad, , Slovakia

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Považská Bystrica, , Slovakia

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Prievidza, , Slovakia

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Trnava, , Slovakia

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Veľký Meder, , Slovakia

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Midrand, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Alberton, , South Africa

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Almería, , Spain

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Granada, , Spain

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Palma de Mallorca, , Spain

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Seville, , Spain

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Seville, , Spain

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Valencia, , Spain

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Countries

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United States Argentina Australia Greece Hungary Mexico Russia Slovakia South Africa Spain

References

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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.

Reference Type RESULT
PMID: 26934259 (View on PubMed)

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.

Reference Type RESULT
PMID: 28294641 (View on PubMed)

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.

Reference Type RESULT
PMID: 28281218 (View on PubMed)

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.

Reference Type RESULT
PMID: 28417535 (View on PubMed)

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.

Reference Type RESULT
PMID: 28643425 (View on PubMed)

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.

Reference Type RESULT
PMID: 29276398 (View on PubMed)

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.

Reference Type RESULT
PMID: 30383495 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39963952 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36710452 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31705547 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2012-004413-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1135-1003

Identifier Type: OTHER

Identifier Source: secondary_id

NN9068-3952

Identifier Type: -

Identifier Source: org_study_id

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