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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03989232
Other study ID # NN9535-4506
Secondary ID U1111-1224-51622
Status Completed
Phase Phase 3
First received
Last updated
Start date June 19, 2019
Est. completion date November 9, 2020

Study information

Verified date February 2023
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 961
Est. completion date November 9, 2020
Est. primary completion date September 18, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Bulgaria Novo Nordisk Investigational Site Kozloduy
Bulgaria Novo Nordisk Investigational Site Montana
Bulgaria Novo Nordisk Investigational Site Petrich
Bulgaria Novo Nordisk Investigational Site Sofia
Bulgaria Novo Nordisk Investigational Site Sofia
Bulgaria Novo Nordisk Investigational Site Stara Zagora
Bulgaria Novo Nordisk Investigational Site Yambol
Canada Novo Nordisk Investigational Site Brampton Ontario
Canada Novo Nordisk Investigational Site Brampton Ontario
Canada Novo Nordisk Investigational Site Etobicoke Ontario
Canada Novo Nordisk Investigational Site London Ontario
Canada Novo Nordisk Investigational Site Markham Ontario
Canada Novo Nordisk Investigational Site Mount Pearl Newfoundland and Labrador
Canada Novo Nordisk Investigational Site Stoney Creek Ontario
Canada Novo Nordisk Investigational Site Toronto Ontario
Czechia Novo Nordisk Investigational Site Ceske Budejovice
Czechia Novo Nordisk Investigational Site Praha 10
Czechia Novo Nordisk Investigational Site Praha 5
Czechia Novo Nordisk Investigational Site Vlasim
Greece Novo Nordisk Investigational Site Athens
Greece Novo Nordisk Investigational Site Athens
Greece Novo Nordisk Investigational Site Athens
Greece Novo Nordisk Investigational Site Athens
Greece Novo Nordisk Investigational Site Athens
Greece Novo Nordisk Investigational Site Thessaloniki
Greece Novo Nordisk Investigational Site Thessaloniki
Greece Novo Nordisk Investigational Site Thessaloniki
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Debrecen
Hungary Novo Nordisk Investigational Site Debrecen
Hungary Novo Nordisk Investigational Site Kaposvár
Hungary Novo Nordisk Investigational Site Komarom
Hungary Novo Nordisk Investigational Site Szeged
Hungary Novo Nordisk Investigational Site Szekszárd
Japan Novo Nordisk Investigational Site Tokyo
Japan Novo Nordisk Investigational Site Tokyo
Poland Novo Nordisk Investigational Site Bialystok
Poland Novo Nordisk Investigational Site Bialystok
Poland Novo Nordisk Investigational Site Gdansk
Poland Novo Nordisk Investigational Site Gorzow Wielkopolski
Poland Novo Nordisk Investigational Site Katowice
Poland Novo Nordisk Investigational Site Lodz
Poland Novo Nordisk Investigational Site Lodz
Poland Novo Nordisk Investigational Site Lublin
Poland Novo Nordisk Investigational Site Warszawa
Poland Novo Nordisk Investigational Site Wroclaw
Puerto Rico Novo Nordisk Investigational Site Manati
Slovakia Novo Nordisk Investigational Site Bratislava
Slovakia Novo Nordisk Investigational Site Hnusta
Slovakia Novo Nordisk Investigational Site Kezmarok
Slovakia Novo Nordisk Investigational Site Kosice
Slovakia Novo Nordisk Investigational Site Krupina
Slovakia Novo Nordisk Investigational Site Levice
Slovakia Novo Nordisk Investigational Site Nove Zamky
Slovakia Novo Nordisk Investigational Site Pezinok
Slovakia Novo Nordisk Investigational Site Poprad
Slovakia Novo Nordisk Investigational Site Povazska Bystrica
Slovakia Novo Nordisk Investigational Site Puchov
Ukraine Novo Nordisk Investigational Site Dnipro
Ukraine Novo Nordisk Investigational Site Mykolaiv
Ukraine Novo Nordisk Investigational Site Ternopil
Ukraine Novo Nordisk Investigational Site Vinnytsia
Ukraine Novo Nordisk Investigational Site Zhytomyr
United States Novo Nordisk Investigational Site Adairsville Georgia
United States Novo Nordisk Investigational Site Alpharetta Georgia
United States Novo Nordisk Investigational Site Birmingham Alabama
United States Novo Nordisk Investigational Site Buena Park California
United States Novo Nordisk Investigational Site Butte Montana
United States Novo Nordisk Investigational Site Carlinville Illinois
United States Novo Nordisk Investigational Site Chandler Arizona
United States Novo Nordisk Investigational Site Chapel Hill North Carolina
United States Novo Nordisk Investigational Site Chattanooga Tennessee
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Colorado Springs Colorado
United States Novo Nordisk Investigational Site Columbus Ohio
United States Novo Nordisk Investigational Site Coral Gables Florida
United States Novo Nordisk Investigational Site Corvallis Oregon
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Fresno California
United States Novo Nordisk Investigational Site Gaffney South Carolina
United States Novo Nordisk Investigational Site Glendale Arizona
United States Novo Nordisk Investigational Site Glendale Arizona
United States Novo Nordisk Investigational Site Greensboro North Carolina
United States Novo Nordisk Investigational Site Greenville South Carolina
United States Novo Nordisk Investigational Site Hollywood Florida
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Humble Texas
United States Novo Nordisk Investigational Site Hurst Texas
United States Novo Nordisk Investigational Site Jacksonville Florida
United States Novo Nordisk Investigational Site Jefferson City Missouri
United States Novo Nordisk Investigational Site Katy Texas
United States Novo Nordisk Investigational Site Kingsport Tennessee
United States Novo Nordisk Investigational Site Lake Charles Louisiana
United States Novo Nordisk Investigational Site Lexington Kentucky
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site Louisville Kentucky
United States Novo Nordisk Investigational Site Mason Ohio
United States Novo Nordisk Investigational Site Memphis Tennessee
United States Novo Nordisk Investigational Site Meridian Idaho
United States Novo Nordisk Investigational Site Mesa Arizona
United States Novo Nordisk Investigational Site New Windsor New York
United States Novo Nordisk Investigational Site Norman Oklahoma
United States Novo Nordisk Investigational Site Olympia Washington
United States Novo Nordisk Investigational Site Peoria Illinois
United States Novo Nordisk Investigational Site Phoenix Arizona
United States Novo Nordisk Investigational Site Plano Texas
United States Novo Nordisk Investigational Site Roswell Georgia
United States Novo Nordisk Investigational Site Salisbury North Carolina
United States Novo Nordisk Investigational Site San Antonio Texas
United States Novo Nordisk Investigational Site San Antonio Texas
United States Novo Nordisk Investigational Site San Diego California
United States Novo Nordisk Investigational Site Shavano Park Texas
United States Novo Nordisk Investigational Site Spring Valley California
United States Novo Nordisk Investigational Site Statesville North Carolina
United States Novo Nordisk Investigational Site Sterling Heights Michigan
United States Novo Nordisk Investigational Site Sugar Land Texas
United States Novo Nordisk Investigational Site Topeka Kansas
United States Novo Nordisk Investigational Site Trenton New Jersey
United States Novo Nordisk Investigational Site Walla Walla Washington
United States Novo Nordisk Investigational Site Walnut Creek California
United States Novo Nordisk Investigational Site Wenatchee Washington
United States Novo Nordisk Investigational Site West Hills California
United States Novo Nordisk Investigational Site Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

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

References & Publications (1)

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, ran — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Week 0, week 40
Secondary 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. Week 0, week 40
Secondary 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. Week 0, week 40
Secondary 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. Week 0, week 40
Secondary 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. Week 0, week 40
Secondary 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. Week 40
Secondary 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. Week 40
Secondary 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. Week 40
Secondary 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. Week 40
Secondary 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. Week 0 to week 47
Secondary 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. Week 0, week 40
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