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A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes

NCT ID: NCT03989232

Last Updated: 2023-02-13

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

961 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-19

Study Completion Date

2020-11-09

Brief Summary

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This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D). People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance. Participants will inject semaglutide under the skin once a week. The study will last for about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study doctor. At the visits participants will have blood taken and eye tests done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Female participants who can get pregnant will be checked 11 times for pregnancy via urine tests.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sponsor staff involved in the clinical trial is masked according to company standard procedures

Study Groups

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Semaglutide 2.0 mg

All participants will receive one injection per week during a 12-week dose escalation period, until the target dose for semaglutide 2.0 mg is reached. From week 13 to week 40, semaglutide will be given in two weekly injections of 1.0 mg each.

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.

Semaglutide 1.0 mg

All participants will receive one injection per week during a 12-week dose escalation period. From week 13 to week 40, the 1.0 mg group will receive an additional injection of semaglutide placebo in order to maintain the blinding.

Group Type ACTIVE_COMPARATOR

Semaglutide

Intervention Type DRUG

Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.

Placebo (semaglutide)

Intervention Type DRUG

Semaglutide placebo injected once-weekly from week 13 to week 40.

Interventions

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Semaglutide

Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.

Intervention Type DRUG

Placebo (semaglutide)

Semaglutide placebo injected once-weekly from week 13 to week 40.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, age equal to or above18 years at the time of signing informed consent
* Diagnosed with T2D at least 180 days prior to the day of screening
* HbA1c of 8-10% (64-86 mmol/mol) (both inclusive)
* Stable daily dose(s) for 90 days prior to the day of screening of:
* Any metformin formulations (equal to or above1500 mg or maximum tolerated or effective dose) alone or in combination with sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose)

* Renal impairment measured as estimated glomerular filtration rate (eGFR) value of \<30 mL/min/1.73 m\^2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) creatinine equation as defined by KDIGO 2012 classification
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
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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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Birmingham, Alabama, United States

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Chandler, Arizona, United States

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Glendale, Arizona, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Buena Park, California, United States

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Fresno, California, United States

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Los Angeles, 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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Walnut Creek, California, United States

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West Hills, California, United States

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Colorado Springs, Colorado, United States

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Coral Gables, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Adairsville, Georgia, United States

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Alpharetta, Georgia, United States

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Roswell, Georgia, United States

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Meridian, Idaho, United States

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Carlinville, Illinois, United States

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Chicago, Illinois, United States

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Peoria, Illinois, United States

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Topeka, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Lake Charles, Louisiana, United States

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Sterling Heights, Michigan, United States

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Jefferson City, Missouri, United States

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Butte, Montana, United States

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Trenton, New Jersey, United States

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New Windsor, New York, United States

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Chapel Hill, North Carolina, United States

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Greensboro, North Carolina, United States

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Salisbury, North Carolina, United States

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Statesville, North Carolina, United States

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Wilmington, North Carolina, United States

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Columbus, Ohio, United States

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Mason, Ohio, United States

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Norman, Oklahoma, United States

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Corvallis, Oregon, United States

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Gaffney, South Carolina, United States

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Greenville, South Carolina, United States

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Chattanooga, Tennessee, United States

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Kingsport, Tennessee, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Humble, Texas, United States

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Hurst, Texas, United States

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Katy, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Shavano Park, Texas, United States

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Sugar Land, Texas, United States

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Olympia, Washington, United States

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Walla Walla, Washington, United States

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Wenatchee, Washington, United States

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Kozloduy, , Bulgaria

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Montana, , Bulgaria

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Petrich, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Yambol, , Bulgaria

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Mount Pearl, Newfoundland and Labrador, Canada

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Brampton, Ontario, Canada

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Etobicoke, Ontario, Canada

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London, Ontario, Canada

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Markham, Ontario, Canada

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Stoney Creek, Ontario, Canada

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Toronto, Ontario, Canada

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České Budějovice, , Czechia

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Prague, , Czechia

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Vlašim, , Czechia

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Athens, , Greece

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Thessaloniki, , Greece

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Budapest, , Hungary

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Debrecen, , Hungary

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Szeged, , Hungary

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Tokyo, , Japan

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Lodz, , Poland

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Wroclaw, , Poland

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Manatí, , Puerto Rico

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Bratislava, , Slovakia

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Hnúšťa, , Slovakia

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Kežmarok, , Slovakia

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Košice, , Slovakia

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Krupina, , Slovakia

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Levice, , Slovakia

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Nové Zámky, , Slovakia

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Pezinok, , Slovakia

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Poprad, , Slovakia

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Považská Bystrica, , Slovakia

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Púchov, , Slovakia

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Dnipro, , Ukraine

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Mykolaiv, , Ukraine

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Ternopil, , Ukraine

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Vinnytsia, , Ukraine

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Zhytomyr, , Ukraine

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Countries

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United States Bulgaria Canada Czechia Greece Hungary Japan Poland Puerto Rico Slovakia Ukraine

References

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Frias JP, Auerbach P, Bajaj HS, Fukushima Y, Lingvay I, Macura S, Sondergaard AL, Tankova TI, Tentolouris N, Buse JB. Efficacy and safety of once-weekly semaglutide 2.0 mg versus 1.0 mg in patients with type 2 diabetes (SUSTAIN FORTE): a double-blind, randomised, phase 3B trial. Lancet Diabetes Endocrinol. 2021 Sep;9(9):563-574. doi: 10.1016/S2213-8587(21)00174-1. Epub 2021 Jul 21.

Reference Type RESULT
PMID: 34293304 (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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U1111-1224-5162

Identifier Type: OTHER

Identifier Source: secondary_id

2018-004529-96

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9535-4506

Identifier Type: -

Identifier Source: org_study_id

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