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Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes

NCT ID: NCT03136484

Last Updated: 2020-01-21

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

788 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2018-11-16

Brief Summary

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This trial is conducted in Africa, Asia, Europe, North and South America. The aim of the trial is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0 mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects with type 2 diabetes (T2D) on a background treatment of metformin

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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

DOUBLE

Participants Investigators

Study Groups

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Semaglutide + canagliflozin placebo

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

Following a dose escalation phase of 8 weeks, semaglutide 1.0 mg once-weekly(administered subcutaneously, s.c., under the skin) and canagliflozin placebo once-daily (administered orally, as a tablet). Subjects will continue on their pre-trial daily dose of metformin.

Placebo (canagliflozin)

Intervention Type DRUG

Following a dose escalation phase of 8 weeks, semaglutide 1.0 mg once-weekly(administered subcutaneously, s.c., under the skin) and canagliflozin placebo once-daily (administered orally, as a tablet). Subjects will continue on their pre-trial daily dose of metformin.

Canagliflozin + semaglutide placebo

Group Type ACTIVE_COMPARATOR

Canagliflozin

Intervention Type DRUG

Following a dose escalation phase of 8 weeks, canagliflozin 300 mg once-daily (administered orally, as a tablet) and semaglutide placebo (administered subcutaneously, s.c., under the skin). Subjects will continue on their pre-trial daily dose of metformin.

Placebo (semaglutide)

Intervention Type DRUG

Following a dose escalation phase of 8 weeks, canagliflozin 300 mg once-daily (administered orally, as a tablet) and semaglutide placebo (administered subcutaneously, s.c., under the skin). Subjects will continue on their pre-trial daily dose of metformin.

Interventions

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Semaglutide

Following a dose escalation phase of 8 weeks, semaglutide 1.0 mg once-weekly(administered subcutaneously, s.c., under the skin) and canagliflozin placebo once-daily (administered orally, as a tablet). Subjects will continue on their pre-trial daily dose of metformin.

Intervention Type DRUG

Canagliflozin

Following a dose escalation phase of 8 weeks, canagliflozin 300 mg once-daily (administered orally, as a tablet) and semaglutide placebo (administered subcutaneously, s.c., under the skin). Subjects will continue on their pre-trial daily dose of metformin.

Intervention Type DRUG

Placebo (canagliflozin)

Following a dose escalation phase of 8 weeks, semaglutide 1.0 mg once-weekly(administered subcutaneously, s.c., under the skin) and canagliflozin placebo once-daily (administered orally, as a tablet). Subjects will continue on their pre-trial daily dose of metformin.

Intervention Type DRUG

Placebo (semaglutide)

Following a dose escalation phase of 8 weeks, canagliflozin 300 mg once-daily (administered orally, as a tablet) and semaglutide placebo (administered subcutaneously, s.c., under the skin). Subjects will continue on their pre-trial daily dose of metformin.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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 equal to or above18 years at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus (T2D) - HbA1c of 7.0-10.

Exclusion Criteria

5% (53-91 mmol/mol, both inclusive) - Stable daily dose of metformin (equal to or above1500 mg or maximum tolerated dose as documented in the subject medical record and in compliance with current local label) for at least 90 days prior to the day of screening Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Previous participation in this trial. Participation is defined as signed informed consent - 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) - Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days prior to the day of screening - Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Subject with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL) - 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) - History of diabetic ketoacidosis (DKA) - Any of the following: myocardial infarction (MI), stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening - Subjects presently classified as being in New York Heart Association (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Renal impairment measured as eGFR below 60 ml/min/1.73 m\^2 as defined by Kidney Disease Improving global outcomes (KDIGO 2012) classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation - Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed - Medical history of diabetes-related lower limb amputations or signs of critical lower limb ischemia, (e.g. skin ulcer, osteomyelitis, or gangrene) within the last 26 weeks prior to 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

Anaheim, California, United States

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La Mesa, California, United States

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Los Angeles, California, United States

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Montclair, California, United States

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San Diego, California, United States

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Spring Valley, California, United States

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Tustin, California, United States

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Walnut Creek, California, United States

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Fleming Island, Florida, United States

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Hallandale, Florida, United States

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Hialeah, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Spring Hill, Florida, United States

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Conyers, Georgia, United States

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Marietta, Georgia, United States

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Meridian, Idaho, United States

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Council Bluffs, Iowa, United States

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Lexington, Kentucky, United States

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Lake Charles, Louisiana, United States

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Metairie, Louisiana, United States

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Baltimore, Maryland, United States

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Hyattsville, Maryland, United States

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Detroit, Michigan, United States

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Flint, Michigan, United States

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Flint, Michigan, United States

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Sterling Heights, Michigan, United States

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Troy, Michigan, United States

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Trenton, New Jersey, United States

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Brooklyn, New York, United States

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New Windsor, New York, United States

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Greensboro, North Carolina, United States

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Cincinnati, Ohio, United States

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Maumee, Ohio, United States

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Toledo, Ohio, United States

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Toledo, Ohio, United States

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Corvallis, Oregon, United States

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Anderson, South Carolina, United States

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Amarillo, Texas, United States

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Corpus Christi, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Katy, Texas, United States

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San Antonio, Texas, United States

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Splendora, Texas, United States

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St. George, Utah, United States

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Herndon, Virginia, United States

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Olympia, Washington, United States

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Wenatchee, Washington, United States

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Buenos Aires, , Argentina

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CABA, , Argentina

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CABA, , Argentina

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Rosario, , Argentina

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Salta, , Argentina

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Porto Alegre, , Brazil

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Rio de Janeiro, , Brazil

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Surrey, British Columbia, Canada

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Brampton, Ontario, Canada

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Burlington, Ontario, Canada

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London, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Pointe-Claire, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Hyderabad, Andhra Pradesh, India

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Rohtak, Haryana, India

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Bangalore, Karnataka, India

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Kochi, Kerala, India

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Mumbai, Maharashtra, India

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Nagpur, Maharashtra, 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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Kolkata, West Bengal, India

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Kolkata, West Bengal, India

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Dublin, , Ireland

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Dublin, , Ireland

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Dublin, , Ireland

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Galway, , Ireland

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Mallow, , Ireland

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Milan, , Italy

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El Achrafiyé, , Lebanon

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Hazmiyeh, , Lebanon

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Lebanon - Beirut, , Lebanon

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Mansourieh, , Lebanon

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Zghartā, , Lebanon

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Alor Gajah, , Malaysia

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George Town, , Malaysia

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Ipoh, , Malaysia

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Malacca, , Malaysia

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Sandakan, , Malaysia

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Seremban, , Malaysia

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Cuernavaca, Morelos, Mexico

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Mexico City, México, D.F., Mexico

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Monterrey, Nuevo León, Mexico

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Eksjö, , Sweden

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Kristianstad, , Sweden

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Lund, , Sweden

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Malmo, , Sweden

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Örebro, , Sweden

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Basingstoke, , United Kingdom

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Bradford-on-Avon, , United Kingdom

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Dundee, , United Kingdom

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Haxey, , United Kingdom

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Nottingham, , United Kingdom

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Plymouth, , United Kingdom

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Soham, , United Kingdom

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Southampton, , United Kingdom

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Stevenage, , United Kingdom

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Torquay, , United Kingdom

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Wellingborough, , United Kingdom

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Countries

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United States Argentina Brazil Canada India Ireland Italy Lebanon Malaysia Mexico Sweden United Kingdom

References

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Lingvay I, Catarig AM, Frias JP, Kumar H, Lausvig NL, le Roux CW, Thielke D, Viljoen A, McCrimmon RJ. Efficacy and safety of once-weekly semaglutide versus daily canagliflozin as add-on to metformin in patients with type 2 diabetes (SUSTAIN 8): a double-blind, phase 3b, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Nov;7(11):834-844. doi: 10.1016/S2213-8587(19)30311-0. Epub 2019 Sep 17.

Reference Type RESULT
PMID: 31540867 (View on PubMed)

McCrimmon RJ, Catarig AM, Frias JP, Lausvig NL, le Roux CW, Thielke D, Lingvay I. Effects of once-weekly semaglutide vs once-daily canagliflozin on body composition in type 2 diabetes: a substudy of the SUSTAIN 8 randomised controlled clinical trial. Diabetologia. 2020 Mar;63(3):473-485. doi: 10.1007/s00125-019-05065-8. Epub 2020 Jan 2.

Reference Type RESULT
PMID: 31897524 (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)

Pulleyblank R, Larsen NB. Cost-Effectiveness of Semaglutide vs. Empagliflozin, Canagliflozin, and Sitagliptin for Treatment of Patients with Type 2 Diabetes in Denmark: A Decision-Analytic Modelling Study. Pharmacoecon Open. 2023 Jul;7(4):579-591. doi: 10.1007/s41669-023-00416-z. Epub 2023 May 13.

Reference Type DERIVED
PMID: 37178435 (View on PubMed)

Lingvay I, Capehorn MS, Catarig AM, Johansen P, Lawson J, Sandberg A, Shaw R, Paine A. Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4593-604. doi: 10.1210/clinem/dgaa577.

Reference Type DERIVED
PMID: 32827435 (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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2016-000989-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1180-3651

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-4270

Identifier Type: -

Identifier Source: org_study_id

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