Clinical trial NCT05144984: A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes
Official title: Investigation of the Safety and Efficacy of Semaglutide s.c. in Combination With NNC0480-0389 in Participants With Type 2 Diabetes - a Dose Finding 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: 2021-12-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes.

The study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to select the doses of the two medicines for other studies.

Participants will either get:

Semaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that looks like the medicines but without any medicine).

NNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by chance.

Participant will need to take 2-3 injections once every week during the study. One injection will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo.

Participant must inject the study medicines themself into the stomach, thigh, or upper arm.

The study will last for about 41weeks. Participant will have 20 clinic visits. Participant will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also have an electrocardiogram (ECG). This is a test to check participants heart. Participant will have their eyes checked before or at the start of the study and at the end of the study.

Women can only take part in the study if they are not able to become pregnant


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
* Participants treated with diet and exercise as monotherapy or in combination with stable daily dose(s) greater than or equal to 90 days before screening of any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose
* HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
* BMI greater than or equal to 25 and below 40 kg/m\^2

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 and prior insulin treatment for gestational diabetes are allowed
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before 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
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D)

Primary outcomes:
measure: Change in HbA1c
timeFrame: From baseline (week 0) to visit 24 (week 34)
Secondary outcomes:
measure: Change in fasting plasma glucose (FPG)
timeFrame: From baseline (week 0) to visit 24 (week 34)
measure: Change in body weight (kg)
timeFrame: From baseline (week 0) to visit 24 (week 34)
measure: Change in body weight (%)
timeFrame: From baseline (week 0) to visit 24 (week 34)
measure: Change in waist circumference
timeFrame: From baseline (week 0) to visit 24 (week 34)
measure: Change in systolic blood pressure (SBP)
timeFrame: From baseline (week 0) to visit 24 (week 34)
measure: Relative change in total cholesterol
timeFrame: From baseline (week 0) to visit 24 (week 34)
measure: Relative change in high-density lipoprotein (HDL) cholesterol
timeFrame: From baseline (week 0) to visit 24 (week 34)
measure: Relative change in low-density lipoprotein (LDL) cholesterol
timeFrame: From baseline (week 0) to visit 24 (week 34)
measure: Relative change in very-low-density lipoprotein (VLDL) cholesterol
timeFrame: From baseline (week 0) to visit 24 (week 34)
measure: Relative change in triglycerides
timeFrame: From baseline (week 0) to visit 24 (week 34)
measure: Relative change in free fatty acids
timeFrame: From baseline (week 0) to visit 24 (week 34)
measure: Relative change in Apolipoprotein B (ApoB)
timeFrame: From baseline (week 0) to visit 24 (week 34)
measure: Relative change in high sensitivity C-Reactive Protein (hsCRP)
timeFrame: From baseline (week 0) to visit 24 (week 34)
measure: Number of treatment-emergent adverse events (TEAEs)
timeFrame: From baseline (week 0) to visit 25 (week 39)
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Velocity Clin Res-Chula Vista
state: California
city: Escondido
country: United States
facility: Headlands Research California, LLC
state: California
city: Fullerton
country: United States
facility: St. Jos Heritage Hlthcr_Fllrtn
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research San Diego
state: California
city: Lancaster
country: United States
facility: First Valley Med Grp Lancaster
state: California
city: Lomita
country: United States
facility: Torrance Clin Res Inst, Inc.
state: California
city: Los Angeles
country: United States
facility: Velocity Clin Res Wstlke
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Riverside
country: United States
facility: Artemis Insitute for Clin Res
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clin Res
state: California
city: West Hills
country: United States
facility: San Fernando Valley Hlth Inst
state: California
city: Jacksonville
country: United States
facility: Northeast Research Institute
state: Florida
city: Miami
country: United States
facility: Reyes Clinical Research, Inc
state: Florida
city: Miramar
country: United States
facility: South Broward Research LLC
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sarasota
country: United States
facility: Headlands Research - Sarasota
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: West Des Moines
country: United States
facility: Iowa Diabetes & Endo Res Ctr
state: Iowa
city: Lexington
country: United States
facility: The Research Group of Lexington LLC
state: Kentucky
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Troy
country: United States
facility: Arcturus Healthcare, PLC
state: Michigan
city: Butte
country: United States
facility: Mercury Str Med Grp, PLLC
state: Montana
city: Albany
country: United States
facility: Albany Medical College - Endo
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest Life Sciences LLC
state: North Carolina
city: Greenville
country: United States
facility: Physicians East Endocrinology
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare/Research
state: North Carolina
city: Maumee
country: United States
facility: Advanced Med Res Maumee
state: Ohio
city: Tulsa
country: United States
facility: Essential Medical Research LLC
state: Oklahoma
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
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: San Antonio
country: United States
facility: Quality Research Inc
state: Texas
city: San Antonio
country: United States
facility: VIP Trials_San Antonio
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Kozloduy
country: Bulgaria
facility: Medical centre "Zdrave 1" OOD
city: Petrich
country: Bulgaria
facility: Individual Practice for medical care -Dr Elizabeta Dimitrova
city: Sofia
country: Bulgaria
facility: UMHAT Aleksandrovska
city: Sofia
country: Bulgaria
facility: Medical centre - Doverie AD
city: Sofia
country: Bulgaria
facility: UMHAT Sofiamed
city: Stara Zagora
country: Bulgaria
facility: "Prevencia-2000-MCOC"
city: Yambol
country: Bulgaria
facility: Medical center Berbatov
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital Diabetes og Hormonsygdomme
city: Hellerup
country: Denmark
facility: Center for Klinisk Metabolisk Forskning
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital Endokrinologisk forsknings afsnit 159
city: Athens
country: Greece
facility: University Hospital of Athens ATTIKON
state: Attica
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: Athens
country: Greece
facility: "Laiko" General Hospital of Athens
city: Thessaloniki
country: Greece
facility: EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
city: Thessaloniki
country: Greece
facility: "Thermi" Private Hosital
city: Pécs
country: Hungary
facility: PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
state: Baranya Vármegye
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Belgyógyászati Klinika
state: Hajdu-Bihar
city: Budapest
country: Hungary
facility: Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Kórház
city: Budapest
country: Hungary
facility: MED-TIMA Kft.
city: Budapest
country: Hungary
facility: MH Egészségügyi Központ
city: Békéscsaba
country: Hungary
facility: Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület
city: Gyula
country: Hungary
facility: Békés Megyei Központi Kórház
city: Kaposvár
country: Hungary
facility: Kaposi Mór Oktató Kórház
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatókórház
city: Tatabánya
country: Hungary
facility: Szent Borbála Kórház
city: Ibaraki
country: Japan
facility: Naka Kinen Clinic
city: Kumamoto
country: Japan
facility: Yoshimura clinic
city: Osaka
country: Japan
facility: Kansai Electric Power Hospital
city: Tokyo
country: Japan
facility: Tokyo Center Clinic
city: Tokyo
country: Japan
facility: ToCROM Clinic
city: Tokyo
country: Japan
facility: Higashi-shinjuku clinic
city: Bialystok
country: Poland
facility: NZOZ Vita-Diabetica Malgorzata Buraczyk
state: Podlaskie Voivodeship
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o.
city: Lodz
country: Poland
facility: Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A.
city: Lodz
country: Poland
facility: FutureMeds Sp. z o.o. Lodz
city: Staszow
country: Poland
facility: Velocity Nova Sp. z o.o.
city: Torun
country: Poland
facility: Osrodek Badan Klinicznych Clinsante
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED Warszawa
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
city: Wroclaw
country: Poland
facility: FutureMeds Sp. z o.o.
city: Zabrze
country: Poland
facility: SPSK nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach, ul. 3-go Maja 13/15 41-800 Zabrze
city: Tumen
country: Russian Federation
facility: Tumen State Medical University
state: Russia
city: Novosibirsk
country: Russian Federation
facility: LLC RC Medical
city: Penza
country: Russian Federation
facility: Penza Regional Clinical Hospital named after N.N. Burdenko
city: Saint-Petersburg
country: Russian Federation
facility: Medinet LLC
city: Belgrade
country: Serbia
facility: CHC Zvezdara, Clinical department for endocrinology
city: Belgrade
country: Serbia
facility: Endocrinology, Diabetes and Metabolism Diseases Clinic
city: Kragujevac
country: Serbia
facility: Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department
city: Kragujevac
country: Serbia
facility: Clinical Centre Kragujevac, Internal Diseases Clinic, Endocr
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: