Clinical trial NCT05486065: A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight
Official title: Investigation of Once-weekly Semaglutide S.C. Dose-Response in Patients With Type 2 Diabetes and Overweight - a Participant- and Investigator-blinded and Sponsor Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-08-03
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Glycated Haemoglobin (HbA1c)
timeFrame: Baseline (week 0) and End of treatment (week 40)
Secondary outcomes:
measure: Change in Body Weight
timeFrame: Baseline (week 0) and End of treatment (week 40)
measure: Number of Treatment-emergent Adverse Events (TEAEs)
timeFrame: From baseline (week 0) up to end of study (week 49)
measure: Number of Treatment-emergent Severe Hypoglycaemic Episodes
timeFrame: From baseline (week 0) up to end of study (week 49)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Banning
country: United States
facility: Velocity Clinical Res-Banning
state: California
city: Coronado
country: United States
facility: Southern California Res Ctr
state: California
city: Gardena
country: United States
facility: Velocity Clin Res Gardena
state: California
city: Huntington Park
country: United States
facility: National Research Institute_Huntington Park
state: California
city: Lancaster
country: United States
facility: First Valley Med Grp Lancaster
state: California
city: Los Angeles
country: United States
facility: Velocity Clin Res Wstlke
state: California
city: San Diego
country: United States
facility: San Diego Family Care_San Diego
state: California
city: San Mateo
country: United States
facility: Mills-Peninsula Hlth Services
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Jacksonville
country: United States
facility: Northeast Res Inst. Inc.
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Res Clin Miami Lakes
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solution
state: Florida
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Council Bluffs
country: United States
facility: West Broadway Clinic
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Clin Research Ctr
state: Kansas
city: Lexington
country: United States
facility: The Research Group of Lexington LLC
state: Kentucky
city: Hyattsville
country: United States
facility: MedStar Community Clin Res Ctr
state: Maryland
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Rockville
country: United States
facility: Endo And Metab Cons
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Troy
country: United States
facility: Arcturus Healthcare, PLC
state: Michigan
city: Saint Peters
country: United States
facility: StudyMetrix Research LLC
state: Missouri
city: Trenton
country: United States
facility: Premier Research Inc.
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College - Endo
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Med Res-New Windsor
state: New York
city: Northport
country: United States
facility: Northport VA Med Ctr Northport
state: New York
city: West Seneca
country: United States
facility: Southgate Medical Group, LLP
state: New York
city: Chapel Hill
country: United States
facility: UNC Eastowne Clinical Research Unit
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Dayton
country: United States
facility: Providence Health Partners Ctr
state: Ohio
city: Maumee
country: United States
facility: Advanced Med Res Maumee
state: Ohio
city: Grants Pass
country: United States
facility: Velocity Clin Res Grants Pass
state: Oregon
city: Medford
country: United States
facility: Velocity Clinical Res Medford
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia
state: Pennsylvania
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Med Spec LLP
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Med Cntr
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Kenosha
country: United States
facility: Clinical Inv Spec, Inc.Kenosha
state: Wisconsin
city: Haidari-Athens
country: Greece
facility: University Hospital of Athens ATTIKON
state: Attica
city: Athens
country: Greece
facility: Iatriko Psychicou Private Clinic
city: Athens
country: Greece
facility: Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
city: Athens
country: Greece
facility: Alexandra General Hospital, Therapeutic Clinic
city: Athens
country: Greece
facility: Iatriko Athinon (Athens Medical Canter)
city: Athens
country: Greece
facility: Iatriko Athinon 'Palaiou Falirou'
city: Thessaloniki
country: Greece
facility: 'Ippokrateio' General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki 'G. Gennimatas
city: Thessaloniki
country: Greece
facility: EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
city: Thessaloniki
country: Greece
facility: "Thermi" Private Hosital
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G.Papanikolaou"
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
state: Csongrád-Csanád
city: Komárom
country: Hungary
facility: Selye János Kórház és Rendelőintézet
state: Komárom-Esztergom
city: Budapest
country: Hungary
facility: Szent Margit Rendelőintézet Nonprofit Kft.
city: Budapest
country: Hungary
facility: ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Kórház
city: Budapest
country: Hungary
facility: MH Egészségügyi Központ
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatókórház
city: Skierniewice
country: Poland
facility: Clinmedica Research sp. z o.o.
state: Lodzkie
city: Warsaw
country: Poland
facility: NBR Polska
state: Mazowieckie
city: Bialystok
country: Poland
facility: NZOZ Vita-Diabetica Malgorzata Buraczyk
state: Podlaskie Voivodeship
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
state: Podlaskie
city: Staszow
country: Poland
facility: Ko-Med Centra Kliniczne Staszow
city: Staszow
country: Poland
facility: Velocity Nova Sp. z o.o.
city: Warszawa
country: Poland
facility: NBR Polska Tomasz Klodawski
city: Katowice
country: Poland
facility: Pro Familia Altera Sp. z o.o.
state: Śląskie
city: Manati
country: Puerto Rico
facility: Manati Ctr For Clin Research
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: