Diabetes Mellitus, Type 2Phase 3SUSTAIN FORTENCT03989232

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

A Phase 3 study testing Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 129 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Semaglutide
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 961 participants
Where: 129 sitesin 11 countries
Study dates: 19 Jun 2019to 9 Nov 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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, as is prior insulin treatment for gestational diabetes
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

Trial locations and contacts

129 sites in 11 countries.

Country

City, postcode or hospital

129 sites in 11 countries

United States61 sites

Novo Nordisk Investigational Site
Adairsville, Georgia, 30103
Novo Nordisk Investigational Site
Alpharetta, Georgia, 30022
Novo Nordisk Investigational Site
Birmingham, Alabama, 35205
Novo Nordisk Investigational Site
Buena Park, California, 90620
Novo Nordisk Investigational Site
Butte, Montana, 59701
Novo Nordisk Investigational Site
Carlinville, Illinois, 62626
Novo Nordisk Investigational Site
Chandler, Arizona, 85224
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27514
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80906
Novo Nordisk Investigational Site
Columbus, Ohio, 43213
Novo Nordisk Investigational Site
Coral Gables, Florida, 33134
Novo Nordisk Investigational Site
Corvallis, Oregon, 97330-3737
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75390-9302
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Gaffney, South Carolina, 29341
Novo Nordisk Investigational Site
Glendale, Arizona, 85306
Novo Nordisk Investigational Site
Glendale, Arizona, 85308
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27408
Novo Nordisk Investigational Site
Greenville, South Carolina, 29615
Novo Nordisk Investigational Site
Hollywood, Florida, 33024
Novo Nordisk Investigational Site
Houston, Texas, 77074
Novo Nordisk Investigational Site
Humble, Texas, 77338
Novo Nordisk Investigational Site
Hurst, Texas, 76054
Novo Nordisk Investigational Site
Jacksonville, Florida, 32216
Novo Nordisk Investigational Site
Jefferson City, Missouri, 65109
Novo Nordisk Investigational Site
Katy, Texas, 77450
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
Lake Charles, Louisiana, 70601
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Louisville, Kentucky, 40213
Novo Nordisk Investigational Site
Mason, Ohio, 45040-6815
Novo Nordisk Investigational Site
Memphis, Tennessee, 38119
Novo Nordisk Investigational Site
Meridian, Idaho, 83646
Novo Nordisk Investigational Site
Mesa, Arizona, 85213
Novo Nordisk Investigational Site
New Windsor, New York, 12553
Novo Nordisk Investigational Site
Norman, Oklahoma, 73069
Novo Nordisk Investigational Site
Olympia, Washington, 98502
Novo Nordisk Investigational Site
Peoria, Illinois, 61603
Novo Nordisk Investigational Site
Phoenix, Arizona, 85050
Novo Nordisk Investigational Site
Plano, Texas, 75075
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Salisbury, North Carolina, 28144
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
San Antonio, Texas, 78230
Novo Nordisk Investigational Site
San Diego, California, 92103
Novo Nordisk Investigational Site
Shavano Park, Texas, 78231
Novo Nordisk Investigational Site
Spring Valley, California, 91978
Novo Nordisk Investigational Site
Statesville, North Carolina, 28625
Novo Nordisk Investigational Site
Sterling Heights, Michigan, 48310-3503
Novo Nordisk Investigational Site
Sugar Land, Texas, 77479
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Novo Nordisk Investigational Site
Trenton, New Jersey, 08611
Novo Nordisk Investigational Site
Walla Walla, Washington, 99362-4445
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
Novo Nordisk Investigational Site
Wenatchee, Washington, 98801-2028
Novo Nordisk Investigational Site
West Hills, California, 91304
Novo Nordisk Investigational Site
Wilmington, North Carolina, 28401

Other trials in United States

Hungary12 sites

Novo Nordisk Investigational Site
Budapest, 1042
Novo Nordisk Investigational Site
Budapest, 1089
Novo Nordisk Investigational Site
Budapest, 1125
Novo Nordisk Investigational Site
Budapest, 1131
Novo Nordisk Investigational Site
Budapest, 1132
Novo Nordisk Investigational Site
Budapest, 1152
Novo Nordisk Investigational Site
Debrecen, 4043
Novo Nordisk Investigational Site
Debrecen, H-4032
Novo Nordisk Investigational Site
Kaposvár, 7400
Novo Nordisk Investigational Site
Komárom, 2900
Novo Nordisk Investigational Site
Szeged, H-6725
Novo Nordisk Investigational Site
Szekszárd, 7100

Other trials in Hungary

Slovakia11 sites

Novo Nordisk Investigational Site
Bratislava, 83103
Novo Nordisk Investigational Site
Hnúšťa, 98101
Novo Nordisk Investigational Site
Kežmarok, 06001
Novo Nordisk Investigational Site
Košice, 04022
Novo Nordisk Investigational Site
Krupina, 96301
Novo Nordisk Investigational Site
Levice, 93401
Novo Nordisk Investigational Site
Nové Zámky, 94070
Novo Nordisk Investigational Site
Pezinok, 90201
Novo Nordisk Investigational Site
Poprad, 05801
Novo Nordisk Investigational Site
Považská Bystrica, 01701
Novo Nordisk Investigational Site
Púchov, 02001

Other trials in Slovakia

Poland10 sites

Novo Nordisk Investigational Site
Bialystok, 15-404
Novo Nordisk Investigational Site
Bialystok, 15-435
Novo Nordisk Investigational Site
Gdansk, 80-214
Novo Nordisk Investigational Site
Gorzów Wielkopolski, 66-400
Novo Nordisk Investigational Site
Katowice, 40-752
Novo Nordisk Investigational Site
Lodz, 90-242
Novo Nordisk Investigational Site
Lodz, 91-849
Novo Nordisk Investigational Site
Lublin, 20-044
Novo Nordisk Investigational Site
Warsaw, 02-097
Novo Nordisk Investigational Site
Wroclaw, 52-416

Other trials in Poland

Canada8 sites

Novo Nordisk Investigational Site
Brampton, Ontario, L6S 0C6
Novo Nordisk Investigational Site
Brampton, Ontario, L6T 0G1
Novo Nordisk Investigational Site
Etobicoke, Ontario, M9R 4E1
Novo Nordisk Investigational Site
London, Ontario, N5W 6A2
Novo Nordisk Investigational Site
Markham, Ontario, L3P 7P2
Novo Nordisk Investigational Site
Mount Pearl, Newfoundland and Labrador, A1N 1W7
Novo Nordisk Investigational Site
Stoney Creek, Ontario, L8J 0B6
Novo Nordisk Investigational Site
Toronto, Ontario, M4G 3E8

Other trials in Canada

Greece8 sites

Novo Nordisk Investigational Site
Athens, 115 25
Novo Nordisk Investigational Site
Athens, GR-10676
Novo Nordisk Investigational Site
Athens, GR-11521
Novo Nordisk Investigational Site
Athens, GR-11527
Novo Nordisk Investigational Site
Athens, GR-17562
Novo Nordisk Investigational Site
Thessaloniki, GR-54642
Novo Nordisk Investigational Site
Thessaloniki, GR-57001
Novo Nordisk Investigational Site
Thessaloniki, GR-57010

Other trials in Greece

Bulgaria7 sites

Novo Nordisk Investigational Site
Kozloduy, 3320
Novo Nordisk Investigational Site
Montana, 3400
Novo Nordisk Investigational Site
Petrich, 2850
Novo Nordisk Investigational Site
Sofia, 1407
Novo Nordisk Investigational Site
Sofia, 1431
Novo Nordisk Investigational Site
Stara Zagora, 6000
Novo Nordisk Investigational Site
Yambol, 8600

Other trials in Bulgaria

Ukraine5 sites

Novo Nordisk Investigational Site
Dnipro, 49038
Novo Nordisk Investigational Site
Mykolaiv, 54003
Novo Nordisk Investigational Site
Ternopil, 46002
Novo Nordisk Investigational Site
Vinnytsia, 21010
Novo Nordisk Investigational Site
Zhytomyr, 10002

Other trials in Ukraine

Czechia4 sites

Novo Nordisk Investigational Site
České Budějovice, 370 01
Novo Nordisk Investigational Site
Prague, 102 00
Novo Nordisk Investigational Site
Prague, 150 00
Novo Nordisk Investigational Site
Vlašim, 25801

Other trials in Czechia

Japan2 sites

Novo Nordisk Investigational Site
Tokyo, 103-0027
Novo Nordisk Investigational Site
Tokyo, 104-0031

Other trials in Japan

Puerto Rico1 site

Novo Nordisk Investigational Site
Manati, 00674

Other trials in Puerto Rico

About this study

Official title: Efficacy and Safety of Semaglutide 2.0 mg s.c. Once-weekly Compared to Semaglutide 1.0 mg s.c. Once-weekly in Subjects With Type 2 Diabetes

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.

Conditions: Diabetes Mellitus, Type 2
Being tested: Semaglutide, Placebo (semaglutide)
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SemaglutideDrug
Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.
Placebo (semaglutide)Drug
Semaglutide placebo injected once-weekly from week 13 to week 40.

Study groups in NCT03989232
Study group	Role	What they receive
Semaglutide 2.0 mg	Experimental	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. Receives: Drug: Semaglutide
Semaglutide 1.0 mg	Active comparator	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. Receives: Drug: Semaglutide; Drug: Placebo (semaglutide)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HbA1c
Change from baseline (week 0) to week 40 in glycosylated haemoglobin (HbA1c) was evaluated.
Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.
Measured: Week 0, week 40

Secondary outcomes (10)

Change in Body Weight
Change from baseline (week 0) to week 40 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.
Measured: Week 0, week 40
Change in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) to week 40 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
Measured: Week 0, week 40
Change in Body Mass Index (BMI)
Change from baseline (week 0) to week 40 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
Measured: Week 0, week 40
Change in Waist Circumference
Change from baseline (week 0) to week 40 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
Measured: Week 0, week 40
Participants Who Achieved HbA1c < 7.0%
Percentage of participants who achieved HbA1c < 7.0% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.
Measured: Week 40
Participants Who Achieved HbA1c ≤ 6.5%
Percentage of participants who achieved HbA1c ≤ 6.5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.
Measured: Week 40
Participants Who Achieved Weight Loss ≥5%
Percentage of participants who achieved weight loss ≥5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.
Measured: Week 40
Participants Who Achieved Weight Loss ≥10%
Percentage of participants who achieved weight loss ≥10% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.
Measured: Week 40
Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that required assistance from another person for recovery and blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 milligrams per deciliter (mg/dL)) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: the follow-up visit (week 47), the treatment discontinuation follow-up visit (end of treatment + 7 weeks), the date of last dose of trial product +49 days or the end-date for the 'in-trial' observation period.
Measured: Week 0 to week 47
Change in Pulse Rate
Change from baseline (week 0) to week 40 in pulse rate is presented. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the endpoint-specific end-date.
Measured: Week 0, week 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jun 20199 Nov 2020

First posted18 Jun 2019
Study start19 Jun 2019
Primary completion18 Sep 2020
Study completion9 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 961 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03989232
Sponsor's protocol ID: NN9535-4506
Other IDs: U1111-1224-5162, 2018-004529-96, 2018
Acronym: SUSTAIN FORTE
Status last verified: Feb 2023
First submitted: 14 Jun 2019
Last updated: 13 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

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.
PubMed 34293304

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Semaglutide 2.0 mg s.c. Once-weekly Compared to Semaglutide 1.0 mg s.c. Once-weekly in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT03989232
Acronym / sponsor ID: SUSTAIN FORTE / NN9535-4506
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 961 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 19 Jun 2019 (actual)
Primary completion: 18 Sep 2020 (actual)
Study completion: 9 Nov 2020 (actual)
First posted: 18 Jun 2019 (actual)
Results: Posted 22 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Semaglutide 2.0 mg	Experimental	Drug: SemaglutideAll 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.
Semaglutide 1.0 mg	Active comparator	Drug: Semaglutide, Drug: Placebo (semaglutide)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (3 listed)

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, as is prior insulin treatment for gestational diabetes
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SemaglutideSemaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.	Drug	Semaglutide 1.0 mg, Semaglutide 2.0 mg
Placebo (semaglutide)Semaglutide placebo injected once-weekly from week 13 to week 40.	Drug	Semaglutide 1.0 mg

Primary outcome

Change in HbA1c
Time frame: Week 0, week 40
Change from baseline (week 0) to week 40 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.

10 secondary outcomes

Change in Body Weight
Time frame: Week 0, week 40
Change in Fasting Plasma Glucose (FPG)
Time frame: Week 0, week 40
Change in Body Mass Index (BMI)
Time frame: Week 0, week 40
Change in Waist Circumference
Time frame: Week 0, week 40
Participants Who Achieved HbA1c < 7.0%
Time frame: Week 40
Participants Who Achieved HbA1c ≤ 6.5%
Time frame: Week 40
Participants Who Achieved Weight Loss ≥5%
Time frame: Week 40
Participants Who Achieved Weight Loss ≥10%
Time frame: Week 40
Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: Week 0 to week 47
Change in Pulse Rate
Time frame: Week 0, week 40

Results and safety

Results posted to the registry on 22 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Semaglutide 1.0 mg	481	471
Semaglutide 2.0 mg	480	462

Primary outcome: Change in HbA1c

Time frame: Week 0, week 40. Mean (Standard Deviation). Unit: Percentage change

Measure	Semaglutide 1.0 mg n = 481	Semaglutide 2.0 mg n = 480
On-treatment without rescue medication	-2.0 (1.0)	-2.2 (1.0)
In-trial	-1.9 (1.0)	-2.2 (1.1)

Semaglutide 1.0 mg vs Semaglutide 2.0 mg: Treatment difference: -0.23 (95% CI -0.36 to -0.11), p = 0.0003, ANCOVA
Semaglutide 1.0 mg vs Semaglutide 2.0 mg: Treatment difference: -0.18 (95% CI -0.31 to -0.04), p = 0.0098, ANCOVA

Population analysed: The FAS included all randomized participants. Number analyzed=number of participants contributed to the analysis.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Weeks 0-47. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Semaglutide 1.0 mg	25 of 480 (5.2%)	126 of 480 (26.3%)	1 of 480
Semaglutide 2.0 mg	21 of 479 (4.4%)	132 of 479 (27.6%)	2 of 479

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 34293304Frias 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.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Reporting Anchor and Disclosure (1452) study director

Novo Nordisk A/S

129 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 129 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Hungary, Slovakia, Poland, Canada and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: Week 0, week 40). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03989232, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.