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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

NCT ID: NCT02773368

Last Updated: 2020-08-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-23

Study Completion Date

2017-10-23

Brief Summary

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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.

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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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IDegLira

Group Type EXPERIMENTAL

insulin degludec/liraglutide

Intervention Type DRUG

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

IGlar

Group Type ACTIVE_COMPARATOR

insulin glargine

Intervention Type DRUG

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

Interventions

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insulin degludec/liraglutide

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

Intervention Type DRUG

insulin glargine

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes mellitus - HbA1c 7.0-11.0% \[53-97 mmol/mol\] (both inclusive) by central laboratory analysis - Body mass index (BMI) equal to or above 20 kg/m\^2 and below 40 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 well as prior insulin treatment for gestational diabetes - A stable daily dose for at least 90 days prior to the day of screening of any SGLT2i in monotherapy or in combination with metformin ± DPP4i ± pioglitazone.

Exclusion Criteria

Use of pioglitazone is not allowed in subjects treated with dapagliflozin Exclusion Criteria: - Receipt of any investigational medicinal product within 90 days prior to screening - Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g., diabetes ketoacidosis) in the previous 90 days prior to the day of the screening - Subjects presently classified as being in NYHA (New York Heart Association) Class III or IV1 - Renal impairment estimated Glomerular Filtration Rate 60 mL/min/1.73 m2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Impaired liver function, defined as ALT (alanine aminotransferase) equal to or above 2.5 times upper normal limit at screening - Known or suspected hypersensitivity to trial product(s) or related products
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

Glendale, Arizona, United States

Site Status

Novo Nordisk Investigational Site

La Jolla, California, United States

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Novo Nordisk Investigational Site

Mission Viejo, California, United States

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Novo Nordisk Investigational Site

Northridge, California, United States

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Novo Nordisk Investigational Site

Palm Springs, California, United States

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Novo Nordisk Investigational Site

San Ramon, California, United States

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Novo Nordisk Investigational Site

Boynton Beach, Florida, United States

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Novo Nordisk Investigational Site

Chiefland, Florida, United States

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Novo Nordisk Investigational Site

Skokie, Illinois, United States

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Novo Nordisk Investigational Site

Avon, Indiana, United States

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Novo Nordisk Investigational Site

Rockville, Maryland, United States

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Novo Nordisk Investigational Site

Las Vegas, Nevada, United States

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Novo Nordisk Investigational Site

Teaneck, New Jersey, United States

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Novo Nordisk Investigational Site

Albany, New York, United States

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Novo Nordisk Investigational Site

West Seneca, New York, United States

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Novo Nordisk Investigational Site

Whiteville, North Carolina, United States

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Novo Nordisk Investigational Site

Mason, Ohio, United States

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Novo Nordisk Investigational Site

Greer, South Carolina, United States

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Novo Nordisk Investigational Site

Bristol, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Longview, Texas, United States

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San Antonio, Texas, United States

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Kenosha, Wisconsin, United States

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Novo Nordisk Investigational Site

Buenos Aires, , Argentina

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Novo Nordisk Investigational Site

CABA, , Argentina

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CABA, , Argentina

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Mendoza, , Argentina

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Winnipeg, Manitoba, Canada

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Moncton, New Brunswick, Canada

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Burlington, Ontario, Canada

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London, Ontario, Canada

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Smiths Falls, Ontario, Canada

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Montreal, Quebec, Canada

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Helsinki, , Finland

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Lahti, , Finland

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Oulu, , Finland

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Rovaniemi, , Finland

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Tampere, , Finland

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Turku, , Finland

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Budapest, , Hungary

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Debrecen, , Hungary

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Komárom, , Hungary

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Salgótarján, , Hungary

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Szekszárd, , Hungary

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Zalaegerszeg, , Hungary

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Hyderbad, Andhra Pradesh, India

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Bhopal, Madhya Pradesh, India

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Pune, Maharashtra, India

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Ludhiana, Punjab, India

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Jaipur, Rajasthan, India

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Chennai, Tamil Nadu, India

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Chennai, Tamil Nadu, India

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Novo Nordisk Investigational Site

Varanasi, Uttar Pradesh, India

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Novo Nordisk Investigational Site

Kolkata, West Bengal, India

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Novo Nordisk Investigational Site

New Delhi, , India

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Novo Nordisk Investigational Site

Barnaul, , Russia

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Novo Nordisk Investigational Site

Moscow, , Russia

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Novo Nordisk Investigational Site

Novosibirsk, , Russia

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Novo Nordisk Investigational Site

Saint Petersburg, , Russia

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Novo Nordisk Investigational Site

Saint Petersburg, , Russia

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Novo Nordisk Investigational Site

Saint Petersburg, , Russia

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Novo Nordisk Investigational Site

Saint-Petesburg, , Russia

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Novo Nordisk Investigational Site

Košice, , Slovakia

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Novo Nordisk Investigational Site

Lučenec, , Slovakia

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Novo Nordisk Investigational Site

Nitra, , Slovakia

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Prešov, , Slovakia

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Trnava, , Slovakia

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Celje, , Slovenia

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Koper, , Slovenia

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Kranj, , Slovenia

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Murska Sobota, , Slovenia

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Trbovlje, , Slovenia

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Almería, , Spain

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Novo Nordisk Investigational Site

Antequera, , Spain

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Novo Nordisk Investigational Site

Barcelona, , Spain

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Novo Nordisk Investigational Site

Boadilla del Monte, , Spain

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Novo Nordisk Investigational Site

Seville, , Spain

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Seville, , Spain

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Novo Nordisk Investigational Site

Villamartín, , Spain

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Novo Nordisk Investigational Site

Baden, , Switzerland

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Novo Nordisk Investigational Site

Geneva, , Switzerland

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Novo Nordisk Investigational Site

Lucerne, , Switzerland

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Novo Nordisk Investigational Site

Olten, , Switzerland

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Novo Nordisk Investigational Site

Schaffhausen, , Switzerland

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Novo Nordisk Investigational Site

Winterthur, , Switzerland

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Novo Nordisk Investigational Site

Zollikerberg, , Switzerland

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Novo Nordisk Investigational Site

Zurich, , Switzerland

Site Status

Countries

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United States Argentina Canada Finland Hungary India Russia Slovakia Slovenia Spain Switzerland

References

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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.

Reference Type RESULT
PMID: 30761720 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2015-001596-48

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1168-9343

Identifier Type: OTHER

Identifier Source: secondary_id

REec-2016-2248

Identifier Type: OTHER

Identifier Source: secondary_id

NN9068-4229

Identifier Type: -

Identifier Source: org_study_id

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