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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Semaglutide
Placebo (semaglutide)
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Semaglutide 2.0 mg

Semaglutide 1.0 mg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 14, 2019
Last Updated
February 10, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03989232
Brief Title
A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes
Acronym
SUSTAIN FORTE
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
September 18, 2020 (Actual)
Study Completion Date
November 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Allocation
Randomized
Enrollment
961 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide 2.0 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Semaglutide 1.0 mg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
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
Intervention Name(s)
Placebo (semaglutide)
Intervention Description
Semaglutide placebo injected once-weekly from week 13 to week 40.
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
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.
Time Frame
Week 0, week 40
Secondary Outcome Measure Information:
Title
Change in Body Weight
Description
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.
Time Frame
Week 0, week 40
Title
Change in Fasting Plasma Glucose (FPG)
Description
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.
Time Frame
Week 0, week 40
Title
Change in Body Mass Index (BMI)
Description
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.
Time Frame
Week 0, week 40
Title
Change in Waist Circumference
Description
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.
Time Frame
Week 0, week 40
Title
Participants Who Achieved HbA1c < 7.0%
Description
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.
Time Frame
Week 40
Title
Participants Who Achieved HbA1c ≤ 6.5%
Description
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.
Time Frame
Week 40
Title
Participants Who Achieved Weight Loss ≥5%
Description
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.
Time Frame
Week 40
Title
Participants Who Achieved Weight Loss ≥10%
Description
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.
Time Frame
Week 40
Title
Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Description
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.
Time Frame
Week 0 to week 47
Title
Change in Pulse Rate
Description
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.
Time Frame
Week 0, week 40

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Anchor and Disclosure (1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
West Hills
State/Province
California
ZIP/Postal Code
91304
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80906
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Adairsville
State/Province
Georgia
ZIP/Postal Code
30103
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Carlinville
State/Province
Illinois
ZIP/Postal Code
62626
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48310-3503
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040-6815
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330-3737
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29341
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9302
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362-4445
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801-2028
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kozloduy
ZIP/Postal Code
3320
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Petrich
ZIP/Postal Code
2850
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Yambol
ZIP/Postal Code
8600
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N 1W7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6S 0C6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M9R 4E1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 7P2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Stoney Creek
State/Province
Ontario
ZIP/Postal Code
L8J 0B6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha 10
ZIP/Postal Code
102 00
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha 5
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Vlasim
ZIP/Postal Code
25801
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
115 25
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-10676
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-11521
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-11527
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-17562
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-54642
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-57001
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-57010
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1042
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1131
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1132
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1152
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Komarom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Szeged
ZIP/Postal Code
H-6725
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Szekszárd
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
ZIP/Postal Code
15-404
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
ZIP/Postal Code
15-435
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gorzow Wielkopolski
ZIP/Postal Code
66-400
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lodz
ZIP/Postal Code
91-849
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lublin
ZIP/Postal Code
20-044
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Manati
ZIP/Postal Code
00674
Country
Puerto Rico
Facility Name
Novo Nordisk Investigational Site
City
Bratislava
ZIP/Postal Code
83103
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Hnusta
ZIP/Postal Code
98101
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Kezmarok
ZIP/Postal Code
06001
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Kosice
ZIP/Postal Code
04022
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Krupina
ZIP/Postal Code
96301
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Levice
ZIP/Postal Code
93401
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Nove Zamky
ZIP/Postal Code
94070
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Pezinok
ZIP/Postal Code
90201
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Poprad
ZIP/Postal Code
05801
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Povazska Bystrica
ZIP/Postal Code
01701
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Puchov
ZIP/Postal Code
02001
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Dnipro
ZIP/Postal Code
49038
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Mykolaiv
ZIP/Postal Code
54003
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Vinnytsia
ZIP/Postal Code
21010
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com
Citations:
PubMed Identifier
34293304
Citation
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.
Results Reference
result

Learn more about this trial

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

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