Clinical trial NCT03989232: A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-06-18
Enrollment: 961
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in HbA1c
timeFrame: Week 0, week 40
Secondary outcomes:
measure: Change in Body Weight
timeFrame: Week 0, week 40
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Week 0, week 40
measure: Change in Body Mass Index (BMI)
timeFrame: Week 0, week 40
measure: Change in Waist Circumference
timeFrame: Week 0, week 40
measure: Participants Who Achieved HbA1c < 7.0%
timeFrame: Week 40
measure: Participants Who Achieved HbA1c ≤ 6.5%
timeFrame: Week 40
measure: Participants Who Achieved Weight Loss ≥5%
timeFrame: Week 40
measure: Participants Who Achieved Weight Loss ≥10%
timeFrame: Week 40
measure: Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
timeFrame: Week 0 to week 47
measure: Change in Pulse Rate
timeFrame: Week 0, week 40
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Chandler
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Glendale
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Glendale
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Buena Park
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Fresno
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Diego
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Spring Valley
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: West Hills
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Coral Gables
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Adairsville
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Alpharetta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Meridian
country: United States
facility: Novo Nordisk Investigational Site
state: Idaho
city: Carlinville
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Topeka
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Lake Charles
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Sterling Heights
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Jefferson City
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Butte
country: United States
facility: Novo Nordisk Investigational Site
state: Montana
city: Trenton
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: New Windsor
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Statesville
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Mason
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Norman
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Corvallis
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Gaffney
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Humble
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Hurst
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Katy
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Plano
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Shavano Park
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Olympia
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Walla Walla
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Wenatchee
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Kozloduy
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Montana
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Petrich
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Stara Zagora
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Yambol
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Mount Pearl
country: Canada
facility: Novo Nordisk Investigational Site
state: Newfoundland and Labrador
city: Brampton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Brampton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Etobicoke
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: London
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Stoney Creek
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Ceske Budejovice
country: Czechia
facility: Novo Nordisk Investigational Site
city: Praha 10
country: Czechia
facility: Novo Nordisk Investigational Site
city: Praha 5
country: Czechia
facility: Novo Nordisk Investigational Site
city: Vlasim
country: Czechia
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Thessaloniki
country: Greece
facility: Novo Nordisk Investigational Site
city: Thessaloniki
country: Greece
facility: Novo Nordisk Investigational Site
city: Thessaloniki
country: Greece
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Debrecen
country: Hungary
facility: Novo Nordisk Investigational Site
city: Debrecen
country: Hungary
facility: Novo Nordisk Investigational Site
city: Kaposvár
country: Hungary
facility: Novo Nordisk Investigational Site
city: Komarom
country: Hungary
facility: Novo Nordisk Investigational Site
city: Szeged
country: Hungary
facility: Novo Nordisk Investigational Site
city: Szekszárd
country: Hungary
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Bialystok
country: Poland
facility: Novo Nordisk Investigational Site
city: Bialystok
country: Poland
facility: Novo Nordisk Investigational Site
city: Gdansk
country: Poland
facility: Novo Nordisk Investigational Site
city: Gorzow Wielkopolski
country: Poland
facility: Novo Nordisk Investigational Site
city: Katowice
country: Poland
facility: Novo Nordisk Investigational Site
city: Lodz
country: Poland
facility: Novo Nordisk Investigational Site
city: Lodz
country: Poland
facility: Novo Nordisk Investigational Site
city: Lublin
country: Poland
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Wroclaw
country: Poland
facility: Novo Nordisk Investigational Site
city: Manati
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Hnusta
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Kezmarok
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Kosice
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Krupina
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Levice
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Nove Zamky
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Pezinok
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Poprad
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Povazska Bystrica
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Puchov
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Dnipro
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Mykolaiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Ternopil
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Vinnytsia
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Zhytomyr
country: Ukraine
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
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.