A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus

This trial is conducted globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: insulin degludec/liraglutide; Drug: insulin glargine; Drug: insulin aspart

• Study Type: Interventional
• Enrollment (Actual): 506
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1440AAD
    • Novo Nordisk Investigational Site
  • Capital Federal, Argentina, 1405
    • Novo Nordisk Investigational Site
  • Córdoba, Argentina, X5006IKK
    • Novo Nordisk Investigational Site
  • Salta, Argentina, 4400
    • Novo Nordisk Investigational Site
• Czechia
  • Brno, Czechia, 65691
    • Novo Nordisk Investigational Site
  • Hradec Králové, Czechia, 500 36
    • Novo Nordisk Investigational Site
  • Olomouc, Czechia, 77900
    • Novo Nordisk Investigational Site
  • Olomouc, Lazce, Czechia, 77900
    • Novo Nordisk Investigational Site
  • Pardubice, Czechia, 53002
    • Novo Nordisk Investigational Site
  • Prostejov, Czechia, 79601
    • Novo Nordisk Investigational Site
• France
  • Angers, France, 49000
    • Novo Nordisk Investigational Site
  • Bourgoin-jallieu, France, 38302
    • Novo Nordisk Investigational Site
  • Brest, France, 29609
    • Novo Nordisk Investigational Site
  • LA ROCHELLE cedex, France, 17019
    • Novo Nordisk Investigational Site
  • Le Coudray, France, 28630
    • Novo Nordisk Investigational Site
  • Le Creusot, France, 71200
    • Novo Nordisk Investigational Site
  • MARSEILLE cedex 08, France, 13285
    • Novo Nordisk Investigational Site
  • Marseille, France, 13008
    • Novo Nordisk Investigational Site
  • Saint Herblain, France, 44800
    • Novo Nordisk Investigational Site
  • Saint Priest en Jarez, France, 42270
    • Novo Nordisk Investigational Site
  • Strasbourg, France, 67098
    • Novo Nordisk Investigational Site
  • Venissieux, France, 69200
    • Novo Nordisk Investigational Site
• Greece
  • Athens, Greece, GR-11527
    • Novo Nordisk Investigational Site
  • Chalkida, Evia, Greece, GR-34100
    • Novo Nordisk Investigational Site
  • Ioannina, Greece, 45500
    • Novo Nordisk Investigational Site
  • Larissa, Greece, GR-41110
    • Novo Nordisk Investigational Site
  • Thessaloniki, Greece, GR-57001
    • Novo Nordisk Investigational Site
  • Thessaloniki, Greece, GR-54642
    • Novo Nordisk Investigational Site
• Hungary
  • Budapest, Hungary, 1115
    • Novo Nordisk Investigational Site
  • Gyula, Hungary, H-5700
    • Novo Nordisk Investigational Site
  • Szeged, Hungary, H-6720
    • Novo Nordisk Investigational Site
  • Szombathely, Hungary, H-9700
    • Novo Nordisk Investigational Site
  • Tatabánya, Hungary, 2800
    • Novo Nordisk Investigational Site
• Israel
  • Haifa, Israel, 35152
    • Novo Nordisk Investigational Site
  • Holon, Israel, 58100
    • Novo Nordisk Investigational Site
  • Jerusalem, Israel, 91120
    • Novo Nordisk Investigational Site
  • Kfar Saba, Israel, 44281
    • Novo Nordisk Investigational Site
  • Nahariya, Israel, 22100
    • Novo Nordisk Investigational Site
  • Rehovot, Israel, 76100
    • Novo Nordisk Investigational Site
• Mexico
  • Aguascalientes, Mexico, 20230
    • Novo Nordisk Investigational Site
  • Durango, Mexico, 34000
    • Novo Nordisk Investigational Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44650
      • Novo Nordisk Investigational Site
  • México, D.F.
    • Mexico City, México, D.F., Mexico, 03300
      • Novo Nordisk Investigational Site
• Russian Federation
  • Kazan, Russian Federation, 420073
    • Novo Nordisk Investigational Site
  • Moscow, Russian Federation, 117036
    • Novo Nordisk Investigational Site
  • Saint-Petersburg, Russian Federation, 199034
    • Novo Nordisk Investigational Site
  • Saint-Petersburg, Russian Federation, 191119
    • Novo Nordisk Investigational Site
  • Saint-Petersburg, Russian Federation, 194354
    • Novo Nordisk Investigational Site
  • Saint-Petersburg, Russian Federation, 194291
    • Novo Nordisk Investigational Site
  • Volgograd, Russian Federation, 400131
    • Novo Nordisk Investigational Site
• Slovakia
  • Bardejov, Slovakia, 08501
    • Novo Nordisk Investigational Site
  • Dolny Kubin, Slovakia, 02601
    • Novo Nordisk Investigational Site
  • Malacky, Slovakia, 90101
    • Novo Nordisk Investigational Site
  • Poprad, Slovakia, 05801
    • Novo Nordisk Investigational Site
  • Roznava, Slovakia, 04801
    • Novo Nordisk Investigational Site
• Spain
  • Almería, Spain, 04001
    • Novo Nordisk Investigational Site
  • Fuenlabrada - Madrid, Spain, 28942
    • Novo Nordisk Investigational Site
  • Pozuelo de Alarcon, Spain, 28223
    • Novo Nordisk Investigational Site
  • Sevilla, Spain, 41010
    • Novo Nordisk Investigational Site
  • Sevilla, Spain, 41003
    • Novo Nordisk Investigational Site
  • Valencia, Spain, 46026
    • Novo Nordisk Investigational Site
• Turkey
  • Ankara, Turkey, 06110
    • Novo Nordisk Investigational Site
  • Ankara, Turkey, 06100
    • Novo Nordisk Investigational Site
  • Antalya, Turkey, 07058
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34096
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34303
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34371
    • Novo Nordisk Investigational Site
• United States
  • Alabama
    • Tuscumbia, Alabama, United States, 35674
      • Novo Nordisk Investigational Site
  • California
    • Anaheim, California, United States, 92801
      • Novo Nordisk Investigational Site
    • Bermuda Dunes, California, United States, 92203
      • Novo Nordisk Investigational Site
    • Fresno, California, United States, 93720
      • Novo Nordisk Investigational Site
    • Lancaster, California, United States, 93534
      • Novo Nordisk Investigational Site
    • Lincoln, California, United States, 95648
      • Novo Nordisk Investigational Site
    • Lomita, California, United States, 90717
      • Novo Nordisk Investigational Site
    • Los Angeles, California, United States, 90057
      • Novo Nordisk Investigational Site
    • Montclair, California, United States, 91763
      • Novo Nordisk Investigational Site
    • Northridge, California, United States, 91325
      • Novo Nordisk Investigational Site
    • San Mateo, California, United States, 94401
      • Novo Nordisk Investigational Site
    • Ventura, California, United States, 93003
      • Novo Nordisk Investigational Site
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Novo Nordisk Investigational Site
  • Florida
    • Palm Harbor, Florida, United States, 34684-3609
      • Novo Nordisk Investigational Site
    • Plantation, Florida, United States, 33324
      • Novo Nordisk Investigational Site
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Novo Nordisk Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Novo Nordisk Investigational Site
    • Skokie, Illinois, United States, 60077
      • Novo Nordisk Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46254
      • Novo Nordisk Investigational Site
  • Louisiana
    • Metairie, Louisiana, United States, 70002
      • Novo Nordisk Investigational Site
    • Natchitoches, Louisiana, United States, 71457-5881
      • Novo Nordisk Investigational Site
    • Shreveport, Louisiana, United States, 71105
      • Novo Nordisk Investigational Site
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Novo Nordisk Investigational Site
  • Massachusetts
    • Waltham, Massachusetts, United States, 02453
      • Novo Nordisk Investigational Site
  • Montana
    • Billings, Montana, United States, 59101
      • Novo Nordisk Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Novo Nordisk Investigational Site
    • Las Vegas, Nevada, United States, 89128
      • Novo Nordisk Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Novo Nordisk Investigational Site
  • New York
    • Albany, New York, United States, 12206
      • Novo Nordisk Investigational Site
    • Jackson Heights, New York, United States, 11372
      • Novo Nordisk Investigational Site
    • New Windsor, New York, United States, 12553
      • Novo Nordisk Investigational Site
    • West Seneca, New York, United States, 14224
      • Novo Nordisk Investigational Site
  • North Carolina
    • Shelby, North Carolina, United States, 28150
      • Novo Nordisk Investigational Site
    • Statesville, North Carolina, United States, 28625
      • Novo Nordisk Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Novo Nordisk Investigational Site
    • Columbus, Ohio, United States, 43213
      • Novo Nordisk Investigational Site
    • Dayton, Ohio, United States, 45439
      • Novo Nordisk Investigational Site
    • Mason, Ohio, United States, 45040-6815
      • Novo Nordisk Investigational Site
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Novo Nordisk Investigational Site
    • Philadelphia, Pennsylvania, United States, 19152
      • Novo Nordisk Investigational Site
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Novo Nordisk Investigational Site
    • Murrells Inlet, South Carolina, United States, 29576
      • Novo Nordisk Investigational Site
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Novo Nordisk Investigational Site
  • Texas
    • Houston, Texas, United States, 77024
      • Novo Nordisk Investigational Site
    • Houston, Texas, United States, 77058
      • Novo Nordisk Investigational Site
    • San Antonio, Texas, United States, 78229
      • Novo Nordisk Investigational Site
    • Sugar Land, Texas, United States, 77478
      • Novo Nordisk Investigational Site
    • Sugar Land, Texas, United States, 77479
      • Novo Nordisk Investigational Site
  • Virginia
    • Midlothian, Virginia, United States, 23114
      • Novo Nordisk Investigational Site
  • Washington
    • Spokane, Washington, United States, 99208
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, age at least 18 years at the time of signing informed consent
• 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

Exclusion Criteria:

• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDegLira	Drug: insulin degludec/liraglutide; Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
Active Comparator: IGlar plus IAsp	Drug: insulin glargine; Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.; Drug: insulin aspart; Injected s.c./subcutaneously (under the skin) before each main meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c (Glycosylated Haemoglobin)	Change in HbA1c values after 26 weeks of treatment.	Week 0, Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.	Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia.	Weeks 0-26
Change in Body Weight	Change in body weight after 26 weeks of treatment.	Week 0, Week 26
Responder for HbA1c Below 7.0%	Number of subjects with HbA1c below 7% after 26 weeks of treatment.	After 26 weeks of treatment
Responder for HbA1c Below or Equal to 6.5 %	Number of subjects with HbA1c below 6.5% after 26 weeks of treatment.	After 26 weeks of treatment

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2015
• Primary Completion (Actual): October 5, 2016
• Study Completion (Actual): October 5, 2016

Study Registration Dates

• First Submitted: April 8, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Insulin; Insulin, Globin Zinc; Insulin Aspart; Liraglutide; Insulin Glargine; Xultophy
• Other Study ID Numbers: NN9068-4185; 2014-003621-18 (EudraCT Number); U1111-1160-6923 (Other Identifier: WHO); REec-2015-1682 (Registry Identifier: Spanish registry)