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Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus

NCT ID: NCT03086330

Last Updated: 2021-07-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2018-08-06

Brief Summary

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This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.

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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

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

Semaglutide, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Semaglutide placebo, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks

Interventions

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Semaglutide

Semaglutide, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks

Intervention Type DRUG

Placebo

Semaglutide placebo, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 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, above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age equal to or above 20 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus
* HbA1c of 7.0-10.0% (53-86 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 (equal to or above 1500 mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of screening. All medications in compliance with current local label

* Subjects with alanine aminotransferase above 2.5 x upper normal limit
* 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
* Any of the following: myocardial infarction, 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 Class IV
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Renal impairment measured as estimated Glomerular Filtration Rate value of eGFR below 60 ml/min/1.73 m\^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry for serum creatinine measured at screening
* 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

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)
* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
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

Andalusia, Alabama, United States

Site Status

Novo Nordisk Investigational Site

Anniston, Alabama, United States

Site Status

Novo Nordisk Investigational Site

Glendale, Arizona, United States

Site Status

Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Site Status

Novo Nordisk Investigational Site

Tempe, Arizona, United States

Site Status

Novo Nordisk Investigational Site

Little Rock, Arkansas, United States

Site Status

Novo Nordisk Investigational Site

La Jolla, California, United States

Site Status

Novo Nordisk Investigational Site

Lincoln, California, United States

Site Status

Novo Nordisk Investigational Site

Northridge, California, United States

Site Status

Novo Nordisk Investigational Site

Edgewater, Florida, United States

Site Status

Novo Nordisk Investigational Site

Maitland, Florida, United States

Site Status

Novo Nordisk Investigational Site

Lawrenceville, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Woodstock, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Hutchinson, Kansas, United States

Site Status

Novo Nordisk Investigational Site

Lexington, Kentucky, United States

Site Status

Novo Nordisk Investigational Site

Baltimore, Maryland, United States

Site Status

Novo Nordisk Investigational Site

Troy, Michigan, United States

Site Status

Novo Nordisk Investigational Site

Jefferson City, Missouri, United States

Site Status

Novo Nordisk Investigational Site

Albany, New York, United States

Site Status

Novo Nordisk Investigational Site

Smithtown, New York, United States

Site Status

Novo Nordisk Investigational Site

West Seneca, New York, United States

Site Status

Novo Nordisk Investigational Site

Charlotte, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Charlotte, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Gastonia, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Greenville, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Kinston, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Morehead City, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Norman, Oklahoma, United States

Site Status

Novo Nordisk Investigational Site

Beaver, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

McMurray, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Arlington, Texas, United States

Site Status

Novo Nordisk Investigational Site

Austin, Texas, United States

Site Status

Novo Nordisk Investigational Site

Dallas, Texas, United States

Site Status

Novo Nordisk Investigational Site

Dallas, Texas, United States

Site Status

Novo Nordisk Investigational Site

Houston, Texas, United States

Site Status

Novo Nordisk Investigational Site

Irving, Texas, United States

Site Status

Novo Nordisk Investigational Site

Shavano Park, Texas, United States

Site Status

Novo Nordisk Investigational Site

Sugar Land, Texas, United States

Site Status

Novo Nordisk Investigational Site

Victoria, Texas, United States

Site Status

Novo Nordisk Investigational Site

Murray, Utah, United States

Site Status

Novo Nordisk Investigational Site

Chesapeake, Virginia, United States

Site Status

Novo Nordisk Investigational Site

Olympia, Washington, United States

Site Status

Novo Nordisk Investigational Site

Saint Stefan, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Edmonton, Alberta, Canada

Site Status

Novo Nordisk Investigational Site

Winnipeg, Manitoba, Canada

Site Status

Novo Nordisk Investigational Site

Brampton, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Brampton, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Etobicoke, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Smiths Falls, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Toronto, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Waterloo, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Kanagawa, , Japan

Site Status

Novo Nordisk Investigational Site

Nagakute-shi, Aichi, , Japan

Site Status

Novo Nordisk Investigational Site

Suita-shi, Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Hamar, , Norway

Site Status

Novo Nordisk Investigational Site

Hoenefoss, , Norway

Site Status

Novo Nordisk Investigational Site

Namsos, , Norway

Site Status

Novo Nordisk Investigational Site

Olso, , Norway

Site Status

Novo Nordisk Investigational Site

Oslo, , Norway

Site Status

Novo Nordisk Investigational Site

Skedsmokorset, , Norway

Site Status

Novo Nordisk Investigational Site

Stavanger, , Norway

Site Status

Novo Nordisk Investigational Site

Ponce, , Puerto Rico

Site Status

Novo Nordisk Investigational Site

Barnaul, , Russia

Site Status

Novo Nordisk Investigational Site

Novosibirsk, , Russia

Site Status

Novo Nordisk Investigational Site

Saint Petersburg, , Russia

Site Status

Novo Nordisk Investigational Site

Saint Petersburg, , Russia

Site Status

Novo Nordisk Investigational Site

Saint Petersburg, , Russia

Site Status

Countries

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United States Austria Canada Japan Norway Puerto Rico Russia

References

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Zinman B, Bhosekar V, Busch R, Holst I, Ludvik B, Thielke D, Thrasher J, Woo V, Philis-Tsimikas A. Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2019 May;7(5):356-367. doi: 10.1016/S2213-8587(19)30066-X. Epub 2019 Mar 1.

Reference Type RESULT
PMID: 30833170 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2016-000904-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1180-1213

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-173542

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9535-4269

Identifier Type: -

Identifier Source: org_study_id

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