A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05144984
• Other study ID #: NN9389-4606
• Secondary ID: U1111-1259-27412
• Status: Completed
• Phase: Phase 2
• Start date: November 29, 2021
• Est. completion date: March 23, 2023

Study information

• Verified date: February 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 23, 2023
• Est. primary completion date: February 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• NNC0480-0389
A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.
• Semaglutide
A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.
• Placebo (NNC080-0389)
A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.
• Placebo (semaglutide)
A weekly dose of placebo (semaglutide). The study will last for about 41weeks.

Locations

Country	Name	City	State
Bulgaria	Medical centre "Zdrave 1" OOD	Kozloduy
Bulgaria	Individual Practice for medical care -Dr Elizabeta Dimitrova	Petrich
Bulgaria	Medical centre - Doverie AD	Sofia
Bulgaria	UMHAT Aleksandrovska	Sofia
Bulgaria	UMHAT Sofiamed	Sofia
Bulgaria	"Prevencia-2000-MCOC"	Stara Zagora
Bulgaria	Medical center Berbatov	Yambol
Denmark	Aarhus Universitetshospital Diabetes og Hormonsygdomme	Aarhus N
Denmark	Center for Klinisk Metabolisk Forskning	Hellerup
Denmark	Hvidovre Hospital Endokrinologisk forsknings afsnit 159	Hvidovre
Greece	"Laiko" General Hospital of Athens	Athens
Greece	Alexandra General Hospital, Therapeutic Clinic	Athens
Greece	Iatriko Athinon 'Palaiou Falirou'	Athens
Greece	Iatriko Athinon (Athens Medical Canter)	Athens
Greece	University Hospital of Athens ATTIKON	Haidari-Athens
Greece	"Thermi" Private Hosital	Thessaloniki
Greece	EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes	Thessaloniki
Hungary	Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház	Békéscsaba
Hungary	Bajcsy-Zsilinszky Kórház	Budapest
Hungary	Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.	Budapest
Hungary	MED-TIMA Kft.	Budapest
Hungary	MH Egészségügyi Központ	Budapest
Hungary	Debreceni Egyetem Belgyógyászati Klinika	Debrecen	Hajdu-Bihar
Hungary	Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület	Debrecen
Hungary	Békés Megyei Központi Kórház	Gyula
Hungary	Kaposi Mór Oktató Kórház	Kaposvár
Hungary	PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum	Pécs
Hungary	Markusovszky Egyetemi Oktatókórház	Szombathely
Hungary	Szent Borbála Kórház	Tatabánya
Japan	Naka Kinen Clinic	Ibaraki
Japan	Yoshimura clinic	Kumamoto
Japan	Kansai Electric Power Hospital	Osaka
Japan	Higashi-shinjuku clinic	Tokyo
Japan	ToCROM Clinic	Tokyo
Japan	Tokyo Center Clinic	Tokyo
Poland	NZOZ Vita-Diabetica Malgorzata Buraczyk	Bialystok	Podlaskie Voivodeship
Poland	Krakowskie Centrum Medyczne Sp. z o.o.	Krakow
Poland	Centrum Terapii Wspolczesnej	Lodz
Poland	FutureMeds Sp. z o.o. Lodz	Lodz
Poland	Ko-Med Nova Sp.zo.o. STASZOW	Staszow
Poland	Osrodek Badan Klinicznych Clinsante	Torun
Poland	Centrum Medyczne AMED Warszawa	Warszawa
Poland	Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji	Warszawa
Poland	FutureMeds Sp. z o.o.	Wroclaw
Poland	SPSK nr 1 im. prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach, ul. 3-go Maja 13/15 41-800 Zabrze	Zabrze
Russian Federation	LLC RC Medical	Novosibirsk
Russian Federation	Penza Regional Clinical Hospital named after N.N. Burdenko	Penza
Russian Federation	Medinet LLC	Saint-Petersburg
Russian Federation	Tumen State Medical University	Tumen	Russia
Serbia	CHC Zvezdara, Clinical department for endocrinology	Belgrade
Serbia	Endocrinology, Diabetes and Metabolism Diseases Clinic	Belgrade
Serbia	Clinical Centre Kragujevac, Internal Diseases Clinic, Endocr	Kragujevac
United States	Albany Medical College - Endo	Albany	New York
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Mercury Str Med Grp, PLLC	Butte	Montana
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Cedar-Crosse Research Center	Chicago	Illinois
United States	Velocity Clin Res-Chula Vista	Chula Vista	California
United States	UT Southwestern Med Cntr	Dallas	Texas
United States	Velocity Clinical Res-Dallas	Dallas	Texas
United States	Headlands Research California, LLC	Escondido	California
United States	St. Jos Heritage Hlthcr_Fllrtn	Fullerton	California
United States	PharmQuest Life Sciences LLC	Greensboro	North Carolina
United States	Physicians East Endocrinology	Greenville	North Carolina
United States	Northeast Research Institute	Jacksonville	Florida
United States	Velocity Clinical Research San Diego	La Mesa	California
United States	First Valley Med Grp Lancaster	Lancaster	California
United States	The Research Group of Lexington LLC	Lexington	Kentucky
United States	Torrance Clin Res Inst, Inc.	Lomita	California
United States	Velocity Clin Res Wstlke	Los Angeles	California
United States	Advanced Med Res Maumee	Maumee	Ohio
United States	Solaris Clinical Research	Meridian	Idaho
United States	Reyes Clinical Research, Inc	Miami	Florida
United States	South Broward Research LLC	Miramar	Florida
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	Progressive Medical Research	Port Orange	Florida
United States	Artemis Insitute for Clin Res	Riverside	California
United States	Quality Research Inc	San Antonio	Texas
United States	VIP Trials_San Antonio	San Antonio	Texas
United States	Artemis Institute for Clin Res	San Diego	California
United States	Headlands Research - Sarasota	Sarasota	Florida
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Piedmont Healthcare/Research	Statesville	North Carolina
United States	Arcturus Healthcare, PLC	Troy	Michigan
United States	Essential Medical Research LLC	Tulsa	Oklahoma
United States	Iowa Diabetes & Endo Res Ctr	West Des Moines	Iowa
United States	San Fernando Valley Hlth Inst	West Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Bulgaria,  Denmark,  Greece,  Hungary,  Japan,  Poland,  Russian Federation,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	percentage-point	From baseline (week 0) to visit 24 (week 34)
Secondary	Change in fasting plasma glucose (FPG)	measured in mmol/L	From baseline (week 0) to visit 24 (week 34)
Secondary	Change in body weight (kg)	measured in kg	From baseline (week 0) to visit 24 (week 34)
Secondary	Change in body weight (%)	measured in percent	From baseline (week 0) to visit 24 (week 34)
Secondary	Change in waist circumference	measured in cm	From baseline (week 0) to visit 24 (week 34)
Secondary	Change in systolic blood pressure (SBP)	measured in mmHg	From baseline (week 0) to visit 24 (week 34)
Secondary	Relative change in total cholesterol	ratio	From baseline (week 0) to visit 24 (week 34)
Secondary	Relative change in high-density lipoprotein (HDL) cholesterol	ratio	From baseline (week 0) to visit 24 (week 34)
Secondary	Relative change in low-density lipoprotein (LDL) cholesterol	ratio	From baseline (week 0) to visit 24 (week 34)
Secondary	Relative change in very-low-density lipoprotein (VLDL) cholesterol	ratio	From baseline (week 0) to visit 24 (week 34)
Secondary	Relative change in triglycerides	ratio	From baseline (week 0) to visit 24 (week 34)
Secondary	Relative change in free fatty acids	ratio	From baseline (week 0) to visit 24 (week 34)
Secondary	Relative change in Apolipoprotein B (ApoB)	ratio	From baseline (week 0) to visit 24 (week 34)
Secondary	Relative change in high sensitivity C-Reactive Protein (hsCRP)	ratio	From baseline (week 0) to visit 24 (week 34)
Secondary	Number of treatment-emergent adverse events (TEAEs)	Count of events	From baseline (week 0) to visit 25 (week 39)