A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Investigation of Clinical Comparability of Semaglutide Drug Products Based on the Proposed and the Approved Drug Substance Manufacturing Processes in Participants With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05478252
• Other study ID #: NN9535-4820
• Secondary ID: U1111-1266-23912
• Status: Completed
• Phase: Phase 3
• Start date: August 3, 2022
• Est. completion date: September 18, 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

The study compares two semaglutide medicines and looks at how well they control blood sugar levels, in participants with type 2 diabetes (T2D). Participants will either get the currently available semaglutide or the semaglutide which is produced through a new manufacturing process. Participants need to take one injection of semaglutide once a week, on the same day of every week. Participants will have a total of 11 clinic visits and the study will last for about 35 weeks (approximately 8 months).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: September 18, 2023
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Diagnosed with type 2 diabetes (T2D) mellitus greater than equal to (=) 180 days before screening.

• Stable daily dose(s) = 90 days prior to the day of screening of metformin = 1500 milligrams (mg) or maximum tolerated or effective dose.

• HbA1c of 7.0-10.5 percentage (%) [53-91.3 millimoles per mole (mmol/mol)] (both inclusive).

Exclusion Criteria:

• Known or suspected hypersensitivity to study intervention(s) or related products.

• 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 nondilated examination.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Semaglutide J
Participants will initially receive 0.25 mg subcutaneous injections of semaglutide J OW and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 28).
• Semaglutide B
Participants will initially receive 0.25 mg subcutaneous injections of semaglutide B OW and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 28).

Locations

Country	Name	City	State
Canada	Centricity Research Brampton	Brampton	Ontario
Canada	Centricity Research Etobicoke	Etobicoke	Ontario
Canada	Nova Scotia Hlth Halifax	Halifax	Nova Scotia
Canada	Wharton Med Clin Trials	Hamilton	Ontario
Canada	Milestone Research	London	Ontario
Canada	G.A. Research Associates Ltd.	Moncton	New Brunswick
Canada	LMC Clin Rsrch Inc. (Montreal)	Montreal	Quebec
Canada	Recherche GCP Research	Montreal	Quebec
Canada	Manna Research Inc.	Pointe Claire	Quebec
Canada	Ocean West Research Clinic	Surrey	British Columbia
Poland	Osteo Medic s.c. Artur Racewicz Jerzy Supronik	Bialystok
Poland	M2M Badania Kliniczne	Chorzów
Poland	NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.	Gdansk
Poland	Krakowskie Centrum Medyczne Sp. z o.o.	Krakow
Poland	Beata Miklaszewicz&Dariusz Dabrowski "CARDIAMED" s.j.	Legnica	Dolnoslaskie
Poland	FutureMeds Sp. z o.o. Lodz	Lodz
Poland	ETG Lublin	Lublin
Poland	ETG Lublin	Lublin	Lubelskie
Poland	Centrum Medyczne "Diabetika"	Radom
Poland	PANSTWOWY INSTYTUT MEDYCZNY MSWiA	Warszawa
Slovakia	Diabetologicka ambulancia DIASTYLE s.r.o.	Banska Bystrica
Slovakia	Diabetologicka ambulancia DIAMO s.r.o.	Kezmarok
Slovakia	IVAMEDIC s.r.o.	Kosice
Slovakia	DIA - SANTMART, s.r.o., Ambulancia diabetologie a poruch latkovej premeny a vyzivy	Martin
Slovakia	Diabetologicka ambulancia MUDr. Iveta Markova s.r.o	Nitra
Slovakia	MUDr. Jan Culak, s.r.o.	Prievidza
Slovakia	MEDI-DIA s.r.o.	Sabinov
South Africa	Medi-Clinic Bloemfontein	Bloemfontein	Free State
South Africa	Moriana Clinical Research	Brandfort	Free State
South Africa	Dr A Amod	Durban	KwaZulu-Natal
South Africa	Dr Pillay's Rooms	Durban	KwaZulu-Natal
South Africa	Precise Clinical Solutions (Pty) Ltd	Durban	KwaZulu-Natal
South Africa	Shop#1 Health Emporium	Midrand	Gauteng
South Africa	Clinical Trial Systems (CTC)	Pretoria	Gauteng
South Africa	Jongaie Research	Pretoria	Gauteng
South Africa	Prinshof Medical Campus	Pretoria	Gauteng
United States	Elligo Clin Res Centre	Austin	Texas
United States	Elite Clinical Trials	Blackfoot	Idaho
United States	Innovative Research of W Florida Inc.	Clearwater	Florida
United States	Velocity Clinical Res-Dallas	Dallas	Texas
United States	Elite Research Center	Flint	Michigan
United States	PharmQuest Life Sciences LLC	Greensboro	North Carolina
United States	Encore Medical Research LLC	Hollywood	Florida
United States	Velocity Clinical Research San Diego	La Mesa	California
United States	The Research Group of Lexington LLC	Lexington	Kentucky
United States	Velocity Clin Res Wstlke	Los Angeles	California
United States	Advanced Med Res Maumee	Maumee	Ohio
United States	International Research Associates, LLC_Miami	Miami	Florida
United States	New Horizon Research Center	Miami	Florida
United States	South Broward Research LLC	Miramar	Florida
United States	BTC of New Bedford, LLC	New Bedford	Massachusetts
United States	Tapia Internal Medicine Clinic	Paris	Texas
United States	South Broward Research LLC	Pembroke Pines	Florida
United States	Tristar Clin Investigations, PC	Philadelphia	Pennsylvania
United States	LCGK Research	San Carlos	California
United States	San Diego Family Care_San Diego	San Diego	California
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Sugar Lakes Family Practice PA	Sugar Land	Texas
United States	Med Partners, Inc.	Toluca Lake	California
United States	Martin Diagnostic Clinic	Tomball	Texas
United States	Arcturus Healthcare, PLC.	Troy	Michigan
United States	University Clin Investigators	Tustin	California
United States	Whiteville Medical Assoc, PA	Whiteville	North Carolina
United States	N.Y. Family Practice Physicians	Woodhaven	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  Poland,  Slovakia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycated Haemoglobin (HbA1c)	Measured as Percentage	From baseline visit (visit 2; week 0) to end of treatment visit (visit 10; week 28)
Secondary	Change in Body Weight	Measured in Kilogram	From baseline visit (visit 2; week 0) to end of treatment visit (visit 10; week 28)
Secondary	Number of Treatment-Emergent Adverse Events	Measured as Number of events	From the time of first dosing (visit 2; week 0) to end of study visit (visit 11; week 33)
Secondary	Occurence of Anti-semaglutide Antibodies (Yes/no)	Measured as Number of participants	From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
Secondary	Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)	Measured as Number of participants	From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
Secondary	Occurence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no)	Measured as Number of participants	From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
Secondary	Occurence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no)	Measured as Number of participants	From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
Secondary	Anti-semaglutide Antibodies Level Measured as %Bound/Total	Antibody levels will be measured in percentage of bound radioactivity-labelled semaglutide/total added radioactivity-labelled semaglutide (%B/T; B =Bound, T = Total).	From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
Secondary	Anti-semaglutide Antibodies Level (Measured as Titre)	Measured as Titre	From baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)