A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight
- Registration Number
- NCT05486065
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study compares how three doses of semaglutide work in participants with type 2 diabetes (T2D) and overweight who are taking metformin. The study will look mainly at how well participant's blood sugar and participant's body weight are controlled when they are taking the study medicine at different doses. Participants will either get semaglutide \[2 milligrams (mg), 8 mg, or 16 mg\] or semaglutide placebo (a dummy medicine). Participants will take the study medicine with an injection pen called NovoPen®4. The injection pen is a medical tool with a needle used to inject the study medicine under the skin. The study will last for about 52 weeks. Participants will have 13 clinic visits and 4 phone calls.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 245
- Male or female.
- Aged 18-64 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus greater than equal to (≥) 180 days prior to the day of screening.
- Glycosylated haemoglobin (HbA1c) of 7.0 - 10.5 percentage (%) [53 - 91 millimoles per mole (mmol/mol)] (both inclusive).
- Body Mass Index (BMI) ≥ 27.0 kilograms per meter square (kg/m^2).
- Stable daily dose(s) ≥ 90 days prior to the day of screening of any metformin formulations.
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before 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.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of 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.
- Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than (<) 30 milliliters per minute (mL/min)/1.73 meter square (m^2) at screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Semaglutide 2 mg Semaglutide Participants will receive once-weekly semaglutide 2 mg subcutaneous (s.c.) injection. Semaglutide placebo 2 mg Placebo Participants will receive once-weekly semaglutide placebo 2 mg s.c. injection. Semaglutide 8 mg Semaglutide Participants will receive once-weekly semaglutide 8 mg s.c. injection. Semaglutide placebo 8 mg Placebo Participants will receive once-weekly semaglutide placebo 8 mg s.c. injection. Semaglutide 16 mg Semaglutide Participants will receive once-weekly semaglutide 16 mg s.c. injection. Semaglutide placebo 16 mg Placebo Participants will receive once-weekly semaglutide placebo 16 mg s.c. injection.
- Primary Outcome Measures
Name Time Method Change in Glycated Haemoglobin (HbA1c) Baseline (week 0) and End of treatment (week 40) Change in HbA1c from baseline (week 0) to end of treatment (week 40) is presented.
- Secondary Outcome Measures
Name Time Method Change in Body Weight Baseline (week 0) and End of treatment (week 40) Change in body weight from baseline (week 0) to end of treatment (week 40) is presented.
Number of Treatment-emergent Adverse Events (TEAEs) From baseline (week 0) up to end of study (week 49) An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with use of investigational medicinal products (IMP), whether or not considered related to IMP. AE can therefore be any unfavourable \& unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with use of IMP. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period data are presented. On-treatment observation period is defined as time points from first drug date until first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until first date of end of study visit or date of death or date of withdrawal of informed consent or contact as defined by investigator for participants that are lost to follow up.
Number of Treatment-emergent Severe Hypoglycaemic Episodes From baseline (week 0) up to end of study (week 49) Number of treatment-emergent severe Hypoglycaemic episodes are presented. Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. On treatment observation period data are presented. On-treatment oberservation period is defined as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until the first date of end of study visit or date of death or date of withdrawal of informed consent or date of last contact as defined by investigator for participants that are lost to follow up.
Trial Locations
- Locations (72)
Univ of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Velocity Clin Res Gardena
🇺🇸Gardena, California, United States
First Valley Med Grp Lancaster
🇺🇸Lancaster, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Velocity Clin Res Wstlke
🇺🇸Los Angeles, California, United States
Mills-Peninsula Hlth Services
🇺🇸San Mateo, California, United States
Velocity Clinical Res-Banning
🇺🇸Banning, California, United States
Northeast Res Inst. Inc.
🇺🇸Jacksonville, Florida, United States
Southern California Res Ctr
🇺🇸Coronado, California, United States
San Diego Family Care_San Diego
🇺🇸San Diego, California, United States
National Research Institute_Huntington Park
🇺🇸Huntington Park, California, United States
San Marcus Res Clin Miami Lakes
🇺🇸Miami Lakes, Florida, United States
Clinical Neuroscience Solution
🇺🇸Orlando, Florida, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
West Broadway Clinic
🇺🇸Council Bluffs, Iowa, United States
Cotton O'Neil Clin Research Ctr
🇺🇸Topeka, Kansas, United States
The Research Group of Lexington LLC
🇺🇸Lexington, Kentucky, United States
MedStar Community Clin Res Ctr
🇺🇸Hyattsville, Maryland, United States
Endo And Metab Cons
🇺🇸Rockville, Maryland, United States
MD Medical Research
🇺🇸Oxon Hill, Maryland, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Arcturus Healthcare, PLC
🇺🇸Troy, Michigan, United States
StudyMetrix Research LLC
🇺🇸Saint Peters, Missouri, United States
Premier Research Inc.
🇺🇸Trenton, New Jersey, United States
Albany Medical College - Endo
🇺🇸Albany, New York, United States
Mid Hudson Med Res-New Windsor
🇺🇸New Windsor, New York, United States
Northport VA Med Ctr Northport
🇺🇸Northport, New York, United States
Southgate Medical Group, LLP
🇺🇸West Seneca, New York, United States
UNC Eastowne Clinical Research Unit
🇺🇸Chapel Hill, North Carolina, United States
Accellacare
🇺🇸Wilmington, North Carolina, United States
Lillestol Research LLC
🇺🇸Fargo, North Dakota, United States
Providence Health Partners Ctr
🇺🇸Dayton, Ohio, United States
Advanced Med Res Maumee
🇺🇸Maumee, Ohio, United States
Velocity Clin Res Grants Pass
🇺🇸Grants Pass, Oregon, United States
Velocity Clinical Res Medford
🇺🇸Medford, Oregon, United States
Clinical Research of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Clinical Neuroscience Solutions
🇺🇸Memphis, Tennessee, United States
Amarillo Med Spec LLP
🇺🇸Amarillo, Texas, United States
Velocity Clinical Res-Dallas
🇺🇸Dallas, Texas, United States
UT Southwestern Med Cntr
🇺🇸Dallas, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Clinical Inv Spec, Inc.Kenosha
🇺🇸Kenosha, Wisconsin, United States
University Hospital of Athens ATTIKON
🇬🇷Haidari-Athens, Attica, Greece
Iatriko Psychicou Private Clinic
🇬🇷Athens, Greece
Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
🇬🇷Athens, Greece
Alexandra General Hospital, Therapeutic Clinic
🇬🇷Athens, Greece
Iatriko Athinon (Athens Medical Canter)
🇬🇷Athens, Greece
Iatriko Athinon 'Palaiou Falirou'
🇬🇷Athens, Greece
'Ippokrateio' General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
General Hospital of Thessaloniki 'G. Gennimatas
🇬🇷Thessaloniki, Greece
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
🇬🇷Thessaloniki, Greece
"Thermi" Private Hosital
🇬🇷Thessaloniki, Greece
General Hospital of Thessaloniki "G.Papanikolaou"
🇬🇷Thessaloniki, Greece
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
🇭🇺Szeged, Csongrád-Csanád, Hungary
Selye János Kórház és Rendelőintézet
🇭🇺Komárom, Komárom-Esztergom, Hungary
Szent Margit Rendelőintézet Nonprofit Kft.
🇭🇺Budapest, Hungary
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
🇭🇺Budapest, Hungary
Bajcsy-Zsilinszky Kórház
🇭🇺Budapest, Hungary
MH Egészségügyi Központ
🇭🇺Budapest, Hungary
Markusovszky Egyetemi Oktatókórház
🇭🇺Szombathely, Hungary
Clinmedica Research sp. z o.o.
🇵🇱Skierniewice, Lodzkie, Poland
NBR Polska
🇵🇱Warsaw, Mazowieckie, Poland
NZOZ Vita-Diabetica Malgorzata Buraczyk
🇵🇱Bialystok, Podlaskie Voivodeship, Poland
Ko-Med Centra Kliniczne Staszow
🇵🇱Staszow, Poland
Velocity Nova Sp. z o.o.
🇵🇱Staszow, Poland
NBR Polska Tomasz Klodawski
🇵🇱Warszawa, Poland
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
🇵🇱Bialystok, Podlaskie, Poland
Manati Ctr For Clin Research
🇵🇷Manati, Puerto Rico
Pro Familia Altera Sp. z o.o.
🇵🇱Katowice, Śląskie, Poland