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LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors.

NCT ID: NCT02964247

Last Updated: 2020-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-03

Study Completion Date

2018-05-08

Brief Summary

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The trial is conducted in Asia, Europe, North America and South America. The aim of the study is to compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor with or without metformin on glycaemic control in subjects with type 2 diabetes mellitus.

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

DOUBLE

Participants Investigators

Study Groups

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liraglutide + SGLT2i ± metformin

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Liraglutide given s.c. once daily, gradually titrated to 1.8 mg/day as an add-on to the subject's stable pre-trial SGLT2 inhibitor ± metformin for 26 weeks

liraglutide placebo + SGLT2i ± metformin

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Liraglutide placebo given s.c. once daily, gradually titrated to 1.8 mg/day as an add-on to the subject's stable pre-trial SGLT2 inhibitor ± metformin for 26 weeks

Interventions

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liraglutide

Liraglutide given s.c. once daily, gradually titrated to 1.8 mg/day as an add-on to the subject's stable pre-trial SGLT2 inhibitor ± metformin for 26 weeks

Intervention Type DRUG

placebo

Liraglutide placebo given s.c. once daily, gradually titrated to 1.8 mg/day as an add-on to the subject's stable pre-trial SGLT2 inhibitor ± metformin for 26 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
* Male or female, age 18 years or older at the time of signing informed consent.
* Diagnosed with type 2 diabetes mellitus.
* HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive).
* Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (1500 mg or more, or maximum tolerated dose) for at least 90 days prior to the day of screening. All medications in compliance with current local label.
* Body mass index of 20 kg/m\^2 or above.

* Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative.
* History or presence of pancreatitis (acute or chronic).
* Impaired liver function, defined as ALT 2.5 or more times upper normal limit at screening.
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV.

Exclusion Criteria

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).
* History of diabetic ketoacidosis while being treated with SGLT2 inhibitors.
* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 60 mL/min/1.73m\^2 as defined by Kidney Disease Improving Global Outcomes (KDIGO) classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening.
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

Locations

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Novo Nordisk Investigational Site

Birmingham, Alabama, United States

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Montgomery, Alabama, United States

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Tucson, Arizona, United States

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Lancaster, California, United States

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Northridge, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Ramon, California, United States

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Vista, California, United States

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Gainesville, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Tampa, Florida, United States

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Lawrenceville, Georgia, United States

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Roswell, Georgia, United States

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Statesboro, Georgia, United States

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Blackfoot, Idaho, United States

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Evansville, Indiana, United States

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Topeka, Kansas, United States

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Lexington, Kentucky, United States

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New Orleans, Louisiana, United States

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Kalamazoo, Michigan, United States

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Rochester, Michigan, United States

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Billings, Montana, United States

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Henderson, Nevada, United States

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Albany, New York, United States

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West Seneca, New York, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Kinston, North Carolina, United States

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Wilmington, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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McMurray, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Moncks Corner, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Myrtle Beach, South Carolina, United States

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Spartanburg, South Carolina, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Edinburg, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Humble, Texas, United States

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Round Rock, Texas, United States

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Schertz, Texas, United States

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Spokane, Washington, United States

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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Ahmedabad, Gujarat, India

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Bangalore, Karnataka, India

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Indore, Madhya Pradesh, India

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Pune, Maharashtra, India

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Jaipur, Rajasthan, India

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Coimbatore, Tamil Nadu, India

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Hyderabad, Telangana, India

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Kolkata, West Bengal, India

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New Delhi, , India

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Haifa, , Israel

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Kfar Saba, , Israel

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Ponce, , Puerto Rico

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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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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Al Ain City, , United Arab Emirates

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Dubai, , United Arab Emirates

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Umm Al Quwain City, , United Arab Emirates

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Novo Nordisk Investigational Site

Umm Al Quwain City, , United Arab Emirates

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Countries

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United States Brazil India Israel Puerto Rico Russia United Arab Emirates

References

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Blonde L, Belousova L, Fainberg U, Garcia-Hernandez PA, Jain SM, Kaltoft MS, Mosenzon O, Nafach J, Palle MS, Rea R. Liraglutide as add-on to sodium-glucose co-transporter-2 inhibitors in patients with inadequately controlled type 2 diabetes: LIRA-ADD2SGLT2i, a 26-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2020 Jun;22(6):929-937. doi: 10.1111/dom.13978. Epub 2020 Feb 14.

Reference Type RESULT
PMID: 31984646 (View on PubMed)

Blonde L, Fainberg U, Kaltoft MS, Mosenzon O, Ramesh C, Rea R. Efficacy of liraglutide added to sodium-glucose cotransporter-2 inhibitors in type 2 diabetes, stratified by baseline characteristics: Post-hoc analysis of LIRA-ADD2SGLT2i. Diabetes Obes Metab. 2021 Oct;23(10):2234-2241. doi: 10.1111/dom.14464. Epub 2021 Jul 8.

Reference Type DERIVED
PMID: 34132018 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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U1111-1184-8086

Identifier Type: OTHER

Identifier Source: secondary_id

NN2211-4315

Identifier Type: -

Identifier Source: org_study_id