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

February 10, 2023 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

961

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kozloduy, Bulgaria, 3320
        • Novo Nordisk INvestigational Site
      • Montana, Bulgaria, 3400
        • Novo Nordisk INvestigational Site
      • Petrich, Bulgaria, 2850
        • Novo Nordisk INvestigational Site
      • Sofia, Bulgaria, 1431
        • Novo Nordisk INvestigational Site
      • Sofia, Bulgaria, 1407
        • Novo Nordisk INvestigational Site
      • Stara Zagora, Bulgaria, 6000
        • Novo Nordisk INvestigational Site
      • Yambol, Bulgaria, 8600
        • Novo Nordisk INvestigational Site
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
        • Novo Nordisk INvestigational Site
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • Novo Nordisk INvestigational Site
      • Brampton, Ontario, Canada, L6T 0G1
        • Novo Nordisk INvestigational Site
      • Etobicoke, Ontario, Canada, M9R 4E1
        • Novo Nordisk INvestigational Site
      • London, Ontario, Canada, N5W 6A2
        • Novo Nordisk INvestigational Site
      • Markham, Ontario, Canada, L3P 7P2
        • Novo Nordisk INvestigational Site
      • Stoney Creek, Ontario, Canada, L8J 0B6
        • Novo Nordisk INvestigational Site
      • Toronto, Ontario, Canada, M4G 3E8
        • Novo Nordisk INvestigational Site
      • Ceske Budejovice, Czechia, 370 01
        • Novo Nordisk INvestigational Site
      • Praha 10, Czechia, 102 00
        • Novo Nordisk INvestigational Site
      • Praha 5, Czechia, 150 00
        • Novo Nordisk INvestigational Site
      • Vlasim, Czechia, 25801
        • Novo Nordisk INvestigational Site
      • Athens, Greece, GR-17562
        • Novo Nordisk INvestigational Site
      • Athens, Greece, GR-11527
        • Novo Nordisk INvestigational Site
      • Athens, Greece, 115 25
        • Novo Nordisk INvestigational Site
      • Athens, Greece, GR-11521
        • Novo Nordisk INvestigational Site
      • Athens, Greece, GR-10676
        • Novo Nordisk INvestigational Site
      • Thessaloniki, Greece, GR-57010
        • Novo Nordisk INvestigational Site
      • Thessaloniki, Greece, GR-57001
        • Novo Nordisk INvestigational Site
      • Thessaloniki, Greece, GR-54642
        • Novo Nordisk INvestigational Site
      • Budapest, Hungary, 1125
        • Novo Nordisk INvestigational Site
      • Budapest, Hungary, 1042
        • Novo Nordisk INvestigational Site
      • Budapest, Hungary, 1089
        • Novo Nordisk INvestigational Site
      • Budapest, Hungary, 1132
        • Novo Nordisk INvestigational Site
      • Budapest, Hungary, 1152
        • Novo Nordisk INvestigational Site
      • Budapest, Hungary, 1131
        • Novo Nordisk INvestigational Site
      • Debrecen, Hungary, 4043
        • Novo Nordisk INvestigational Site
      • Debrecen, Hungary, H-4032
        • Novo Nordisk INvestigational Site
      • Kaposvár, Hungary, 7400
        • Novo Nordisk INvestigational Site
      • Komarom, Hungary, 2900
        • Novo Nordisk INvestigational Site
      • Szeged, Hungary, H-6725
        • Novo Nordisk INvestigational Site
      • Szekszárd, Hungary, 7100
        • Novo Nordisk INvestigational Site
      • Tokyo, Japan, 103-0027
        • Novo Nordisk INvestigational Site
      • Tokyo, Japan, 104-0031
        • Novo Nordisk INvestigational Site
      • Bialystok, Poland, 15-404
        • Novo Nordisk INvestigational Site
      • Bialystok, Poland, 15-435
        • Novo Nordisk INvestigational Site
      • Gdansk, Poland, 80-214
        • Novo Nordisk INvestigational Site
      • Gorzow Wielkopolski, Poland, 66-400
        • Novo Nordisk INvestigational Site
      • Katowice, Poland, 40-752
        • Novo Nordisk INvestigational Site
      • Lodz, Poland, 90-242
        • Novo Nordisk INvestigational Site
      • Lodz, Poland, 91-849
        • Novo Nordisk INvestigational Site
      • Lublin, Poland, 20-044
        • Novo Nordisk INvestigational Site
      • Warszawa, Poland, 02-097
        • Novo Nordisk INvestigational Site
      • Wroclaw, Poland, 52-416
        • Novo Nordisk INvestigational Site
      • Manati, Puerto Rico, 00674
        • Novo Nordisk INvestigational Site
      • Bratislava, Slovakia, 83103
        • Novo Nordisk INvestigational Site
      • Hnusta, Slovakia, 98101
        • Novo Nordisk INvestigational Site
      • Kezmarok, Slovakia, 06001
        • Novo Nordisk INvestigational Site
      • Kosice, Slovakia, 04022
        • Novo Nordisk INvestigational Site
      • Krupina, Slovakia, 96301
        • Novo Nordisk INvestigational Site
      • Levice, Slovakia, 93401
        • Novo Nordisk INvestigational Site
      • Nove Zamky, Slovakia, 94070
        • Novo Nordisk INvestigational Site
      • Pezinok, Slovakia, 90201
        • Novo Nordisk INvestigational Site
      • Poprad, Slovakia, 05801
        • Novo Nordisk INvestigational Site
      • Povazska Bystrica, Slovakia, 01701
        • Novo Nordisk INvestigational Site
      • Puchov, Slovakia, 02001
        • Novo Nordisk INvestigational Site
      • Dnipro, Ukraine, 49038
        • Novo Nordisk INvestigational Site
      • Mykolaiv, Ukraine, 54003
        • Novo Nordisk INvestigational Site
      • Ternopil, Ukraine, 46002
        • Novo Nordisk INvestigational Site
      • Vinnytsia, Ukraine, 21010
        • Novo Nordisk INvestigational Site
      • Zhytomyr, Ukraine, 10002
        • Novo Nordisk INvestigational Site
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Novo Nordisk INvestigational Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Novo Nordisk INvestigational Site
      • Glendale, Arizona, United States, 85306
        • Novo Nordisk INvestigational Site
      • Glendale, Arizona, United States, 85308
        • Novo Nordisk INvestigational Site
      • Mesa, Arizona, United States, 85213
        • Novo Nordisk INvestigational Site
      • Phoenix, Arizona, United States, 85050
        • Novo Nordisk INvestigational Site
    • California
      • Buena Park, California, United States, 90620
        • Novo Nordisk INvestigational Site
      • Fresno, California, United States, 93720
        • Novo Nordisk INvestigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk INvestigational Site
      • San Diego, California, United States, 92103
        • Novo Nordisk INvestigational Site
      • Spring Valley, California, United States, 91978
        • Novo Nordisk INvestigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk INvestigational Site
      • West Hills, California, United States, 91304
        • Novo Nordisk INvestigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80906
        • Novo Nordisk INvestigational Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Novo Nordisk INvestigational Site
      • Hollywood, Florida, United States, 33024
        • Novo Nordisk INvestigational Site
      • Jacksonville, Florida, United States, 32216
        • Novo Nordisk INvestigational Site
    • Georgia
      • Adairsville, Georgia, United States, 30103
        • Novo Nordisk INvestigational Site
      • Alpharetta, Georgia, United States, 30022
        • Novo Nordisk INvestigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk INvestigational Site
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Novo Nordisk INvestigational Site
    • Illinois
      • Carlinville, Illinois, United States, 62626
        • Novo Nordisk INvestigational Site
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk INvestigational Site
      • Peoria, Illinois, United States, 61603
        • Novo Nordisk INvestigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk INvestigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk INvestigational Site
      • Louisville, Kentucky, United States, 40213
        • Novo Nordisk INvestigational Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Novo Nordisk INvestigational Site
    • Michigan
      • Sterling Heights, Michigan, United States, 48310-3503
        • Novo Nordisk INvestigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Novo Nordisk INvestigational Site
    • Montana
      • Butte, Montana, United States, 59701
        • Novo Nordisk INvestigational Site
    • New Jersey
      • Trenton, New Jersey, United States, 08611
        • Novo Nordisk INvestigational Site
    • New York
      • New Windsor, New York, United States, 12553
        • Novo Nordisk INvestigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Novo Nordisk INvestigational Site
      • Greensboro, North Carolina, United States, 27408
        • Novo Nordisk INvestigational Site
      • Salisbury, North Carolina, United States, 28144
        • Novo Nordisk INvestigational Site
      • Statesville, North Carolina, United States, 28625
        • Novo Nordisk INvestigational Site
      • Wilmington, North Carolina, United States, 28401
        • Novo Nordisk INvestigational Site
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Novo Nordisk INvestigational Site
      • Mason, Ohio, United States, 45040-6815
        • Novo Nordisk INvestigational Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Novo Nordisk INvestigational Site
    • Oregon
      • Corvallis, Oregon, United States, 97330-3737
        • Novo Nordisk INvestigational Site
    • South Carolina
      • Gaffney, South Carolina, United States, 29341
        • Novo Nordisk INvestigational Site
      • Greenville, South Carolina, United States, 29615
        • Novo Nordisk INvestigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk INvestigational Site
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk INvestigational Site
      • Memphis, Tennessee, United States, 38119
        • Novo Nordisk INvestigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Novo Nordisk INvestigational Site
      • Dallas, Texas, United States, 75390-9302
        • Novo Nordisk INvestigational Site
      • Houston, Texas, United States, 77074
        • Novo Nordisk INvestigational Site
      • Humble, Texas, United States, 77338
        • Novo Nordisk INvestigational Site
      • Hurst, Texas, United States, 76054
        • Novo Nordisk INvestigational Site
      • Katy, Texas, United States, 77450
        • Novo Nordisk INvestigational Site
      • Plano, Texas, United States, 75075
        • Novo Nordisk INvestigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk INvestigational Site
      • San Antonio, Texas, United States, 78230
        • Novo Nordisk INvestigational Site
      • Shavano Park, Texas, United States, 78231
        • Novo Nordisk INvestigational Site
      • Sugar Land, Texas, United States, 77479
        • Novo Nordisk INvestigational Site
    • Washington
      • Olympia, Washington, United States, 98502
        • Novo Nordisk INvestigational Site
      • Walla Walla, Washington, United States, 99362-4445
        • Novo Nordisk INvestigational Site
      • Wenatchee, Washington, United States, 98801-2028
        • Novo Nordisk INvestigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.
ACTIVE_COMPARATOR: 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.
Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.
Semaglutide placebo injected once-weekly from week 13 to week 40.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Week 0, week 40

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 19, 2019

Primary Completion (ACTUAL)

September 18, 2020

Study Completion (ACTUAL)

November 9, 2020

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

June 14, 2019

First Posted (ACTUAL)

June 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • NN9535-4506
  • U1111-1224-5162 (OTHER: World Health Organization (WHO))
  • 2018-004529-96 (REGISTRY: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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