A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus

NCT02773368 | Completed Phase 3 Results

• 4 other identifiers: NN9068-42292015-001596-48U1111-1168-9343REec-2016-2248
• Study Type: interventional
• Target: 420
• Locations: 10 countries
• Sites: 83

Brief Summary

This trial is conducted globally. The aim of this trial is comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i (sodium-glucose cotransporter 2 inhibitors) in subjects with type 2 diabetes mellitus.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c (Glycosylated Haemoglobin)

  The mean change from baseline (week 0) in HbA1c values evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.

  Week 0, Week 26

Secondary Outcomes (32)

• Change in Body Weight

  Week 0, Week 26

• Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes

  Week 0-26

• Insulin Dose, Total Daily Dose (U)

  After 26 weeks

• Change in Fasting Plasma Glucose (FPG)

  Week 0, Week 26

• Number of Treatment-emergent Adverse Events

  Week 0-26

Study Arms (2)

IDegLira

EXPERIMENTAL

Drug: insulin degludec/liraglutide

IGlar

ACTIVE COMPARATOR

Drug: insulin glargine

Interventions

insulin degludec/liraglutide DRUG

IDegLira will be given subcutaneously ( s.c., under the skin) once daily.

IDegLira

insulin glargine DRUG

IGlar will be given subcutaneously ( s.c., under the skin) once daily.

IGlar

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 (88)

Novo Nordisk Investigational Site

Glendale, Arizona, 85308, United States

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Novo Nordisk Investigational Site

La Jolla, California, 92037, United States

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Novo Nordisk Investigational Site

Mission Viejo, California, 92691, United States

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Novo Nordisk Investigational Site

Northridge, California, 91325, United States

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Palm Springs, California, 92262, United States

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San Ramon, California, 94583, United States

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Boynton Beach, Florida, 33472, United States

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Chiefland, Florida, 32626, United States

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Skokie, Illinois, 60077, United States

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Avon, Indiana, 46123, United States

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Rockville, Maryland, 20852, United States

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Las Vegas, Nevada, 89118, United States

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Teaneck, New Jersey, 07666, United States

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Albany, New York, 12206, United States

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West Seneca, New York, 14224, United States

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Whiteville, North Carolina, 28472, United States

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Mason, Ohio, 45040-6815, United States

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Greer, South Carolina, 29651, United States

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Bristol, Tennessee, 37620-7352, United States

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Austin, Texas, 78731, United States

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Houston, Texas, 77081, United States

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Longview, Texas, 75605, United States

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San Antonio, Texas, 78228-3419, United States

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Kenosha, Wisconsin, 53144, United States

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Buenos Aires, C1425AGC, Argentina

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CABA, C1120AAC, Argentina

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CABA, C1180AAX, Argentina

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Mendoza, 5500, Argentina

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Winnipeg, Manitoba, R2V 4W3, Canada

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Moncton, New Brunswick, E1G 1A7, Canada

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Burlington, Ontario, L7M 4Y1, Canada

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London, Ontario, N6G 2M1, Canada

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Smiths Falls, Ontario, K7A 4W8, Canada

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Montreal, Quebec, H4A 3T2, Canada

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Helsinki, 00100, Finland

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Lahti, 15110, Finland

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Oulu, FI-90220, Finland

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Rovaniemi, 96400, Finland

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Tampere, 33520, Finland

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Turku, 20520, Finland

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Novo Nordisk Investigational Site

Budapest, 1042, Hungary

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Debrecen, 4043, Hungary

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Komárom, 2900, Hungary

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Salgótarján, 3100, Hungary

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Szekszárd, 7100, Hungary

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Zalaegerszeg, 8900, Hungary

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Hyderbad, Andhra Pradesh, 500 012, India

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Bhopal, Madhya Pradesh, 462037, India

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Pune, Maharashtra, 411040, India

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Ludhiana, Punjab, 141001, India

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Jaipur, Rajasthan, 302004, India

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Chennai, Tamil Nadu, 600029, India

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Chennai, Tamil Nadu, 600086, India

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Novo Nordisk Investigational Site

Varanasi, Uttar Pradesh, 221105, India

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Kolkata, West Bengal, 700054, India

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Novo Nordisk Investigational Site

New Delhi, 110001, India

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Novo Nordisk Investigational Site

Barnaul, 656043, Russia

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Moscow, 123423, Russia

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Novosibirsk, 630047, Russia

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Saint Petersburg, 191119, Russia

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Novo Nordisk Investigational Site

Saint Petersburg, 194354, Russia

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Novo Nordisk Investigational Site

Saint Petersburg, 194358, Russia

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Novo Nordisk Investigational Site

Saint-Petesburg, 195257, Russia

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Novo Nordisk Investigational Site

Košice, 040 01, Slovakia

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Novo Nordisk Investigational Site

Lučenec, 984 01, Slovakia

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Novo Nordisk Investigational Site

Nitra, 94901, Slovakia

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Novo Nordisk Investigational Site

Prešov, 080 01, Slovakia

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Novo Nordisk Investigational Site

Trnava, 91701, Slovakia

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Novo Nordisk Investigational Site

Celje, SI-3000, Slovenia

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Novo Nordisk Investigational Site

Koper, SI-6000, Slovenia

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Novo Nordisk Investigational Site

Kranj, 4000, Slovenia

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Murska Sobota, SI-9000, Slovenia

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Novo Nordisk Investigational Site

Trbovlje, 1420, Slovenia

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Novo Nordisk Investigational Site

Almería, 04001, Spain

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Novo Nordisk Investigational Site

Antequera, 29200, Spain

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Novo Nordisk Investigational Site

Barcelona, 08035, Spain

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Novo Nordisk Investigational Site

Boadilla del Monte, 28660, Spain

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Novo Nordisk Investigational Site

Seville, 41003, Spain

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Novo Nordisk Investigational Site

Seville, 41009, Spain

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Novo Nordisk Investigational Site

Villamartín, 11650, Spain

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Novo Nordisk Investigational Site

Baden, 5400, Switzerland

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Geneva, 1211, Switzerland

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Lucerne, 6000, Switzerland

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Olten, 4600, Switzerland

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Schaffhausen, 8208, Switzerland

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Novo Nordisk Investigational Site

Winterthur, 8400, Switzerland

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Novo Nordisk Investigational Site

Zollikerberg, 8125, Switzerland

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Novo Nordisk Investigational Site

Zurich, 8091, Switzerland

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Related Publications (1)

• Philis-Tsimikas A, Billings LK, Busch R, Portillo CM, Sahay R, Halladin N, Eggert S, Begtrup K, Harris S. Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add-on to sodium-glucose co-transporter-2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes. Diabetes Obes Metab. 2019 Jun;21(6):1399-1408. doi: 10.1111/dom.13666. Epub 2019 Apr 4.

  PMID: 30761720 RESULT

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: Clinical Reporting Anchor and Disclosure (1452)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

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: May 13, 2016
• First Posted: May 16, 2016
• Study Start: May 23, 2016
• Primary Completion: September 26, 2017
• Study Completion: October 23, 2017
• Last Updated: August 11, 2020
• Results First Posted: October 23, 2018

Record last verified: 2020-08

Locations

RU (7); CA (6); SL (5); US (24); ES (7); CH (8); FI (6); AR (4); HU (6); IN (10)