Clinical Trial Details
| Trial ID: | L5689 |
| Source ID: | NCT05478252 |
| Associated Drug: | Semaglutide J |
| Title: | A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT05478252/results |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Semaglutide J|DRUG: Semaglutide B |
| Outcome Measures: | Primary: Change in Glycosylated Haemoglobin (HbA1c), Change in HbA1c from baseline (week 0) to end of treatment (week 28) is presented. The endpoint was evaluated based on the data from in-study period. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site., From baseline (week 0) to end of treatment (week 28) | Secondary: Change in Body Weight, Change in body weight from baseline (week 0) to end of treatment (week 28) is presented. The endpoint was evaluated based on the data from in-study period. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site., From baseline (week 0) to end of treatment (week 28)|Number of Treatment-Emergent Adverse Events (TEAEs), An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP. All presented adverse events are TEAE. A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study., From the time of first dosing (week 0) to end of study (week 33)|Occurrence of Anti-semaglutide Antibodies (Yes/no), Occurrence of anti-semaglutide antibodies for in-study observation period is presented. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. In the reported data 'yes' infers who tested positive for anti-semaglutide antibodies, whereas 'No' infers who tested negative for anti semaglutide antibodies., From baseline (week 0) to end of study (week 33)|Occurrence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no), Occurrence of anti-semaglutide antibodies with in-vitro neutralizing effect was to be performed based on positive cross -reactivity to GLP-1. Since there was no sample with positive cross -reactivity to GLP-1, no further analysis was performed for invitro neutralizing effect towards native-GLP1. Therefore, no data is available for this end point. In the reported data 'yes' infers who tested positive for anti-semaglutide antibodies whereas 'No' infers who tested negative for anti-semaglutide antibodies., From baseline (week 0) to end of study (week 33)|Occurrence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no), Occurrence of anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) for in-study observation period is presented. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. In the reported data 'yes' infers who tested positive for anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) whereas 'No' infers who tested negative for anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1)., From baseline (week 0) to end of study (week 33)|Occurrence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no), Occurrence of in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 at week 33 is presented. In the reported data 'yes' infers who tested positive for in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 whereas 'No' infers who tested negative for in-vitro neutralising cross-reacting antibodies to endogenous GLP-1., At week 33|Anti-semaglutide Antibodies Level Measured as Percentage (%) Bound/Total, Anti-semaglutide antibodies level measured as %Bound/Total at week 33 is presented., At week 33|Anti-semaglutide Antibodies Level (Measured as Titre), Anti-semaglutide antibodies level measured as titre at week 33 is presented., At week 33 |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE3 |
| Enrollment: | 388 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2022-08-03 |
| Completion Date: | 2023-09-18 |
| Results First Posted: | 2024-10-09 |
| Last Update Posted: | 2024-10-09 |
| Locations: | Velocity Clinical Research San Diego, La Mesa, California, 91942, United States|Velocity Clin Res Wstlke, Los Angeles, California, 90057, United States|LCGK Research, San Carlos, California, 94070, United States|San Diego Family Care_San Diego, San Diego, California, 92111, United States|Med Partners, Inc., Toluca Lake, California, 91602, United States|University Clin Investigators, Tustin, California, 92780, United States|Innovative Research of W Florida Inc., Clearwater, Florida, 33756, United States|Innovative Research of W FL, Clearwater, Florida, 33756, United States|Encore Medical Research LLC, Hollywood, Florida, 33021, United States|New Horizon Research Center, Miami, Florida, 33165, United States|International Research Associates, LLC_Miami, Miami, Florida, 33183, United States|South Broward Research LLC, Miramar, Florida, 33027, United States|South Broward Research LLC, Pembroke Pines, Florida, 33027, United States|Elite Clinical Trials, Blackfoot, Idaho, 83221, United States|The Research Group of Lexington LLC, Lexington, Kentucky, 40503, United States|BTC of New Bedford, LLC, New Bedford, Massachusetts, 02740, United States|Elite Research Center, Flint, Michigan, 48532, United States|Arcturus Healthcare, PLC., Troy, Michigan, 48098, United States|N.Y. Family Practice Physicians, Woodhaven, New York, 11421, United States|PharmQuest Life Sciences LLC, Greensboro, North Carolina, 27408, United States|Whiteville Medical Assoc, PA, Whiteville, North Carolina, 28472, United States|Advanced Med Res Maumee, Maumee, Ohio, 43537, United States|Tristar Clin Investigations, PC, Philadelphia, Pennsylvania, 19114, United States|Spartanburg Medical Research, Spartanburg, South Carolina, 29303, United States|Elligo Clin Res Centre, Austin, Texas, 78704, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|Tapia Internal Medicine Clinic, Paris, Texas, 75462, United States|Sugar Lakes Family Practice PA, Sugar Land, Texas, 77479, United States|Martin Diagnostic Clinic, Tomball, Texas, 77375, United States|Ocean West Research Clinic, Surrey, British Columbia, V3Z 2N6, Canada|G.A. Research Associates Ltd., Moncton, New Brunswick, E1G 1A7, Canada|Nova Scotia Hlth Halifax, Halifax, Nova Scotia, B3H 2Y9, Canada|Centricity Research Brampton, Brampton, Ontario, L6S 0C6, Canada|Centricity Research Etobicoke, Etobicoke, Ontario, M9R 4E1, Canada|Wharton Med Clin Trials, Hamilton, Ontario, L8L 5G8, Canada|Milestone Research, London, Ontario, N5W 6A2, Canada|Recherche GCP Research, Montreal, Quebec, H1Y 3H5, Canada|LMC Clin Rsrch Inc. (Montreal), Montreal, Quebec, H4T 1Z9, Canada|Manna Research Inc., Pointe Claire, Quebec, H9R 4S3, Canada|Beata Mikłaszewicz&Dariusz Dąbrowski "CARDIAMED" s.j., Legnica, Dolnoslaskie, 59-220, Poland|ETG Lublin, Lublin, Lubelskie, 20-412, Poland|Osteo Medic s.c. Artur Racewicz Jerzy Supronik, Bialystok, 15-351, Poland|M2M Badania Kliniczne, Chorzów, 41-500, Poland|NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o., Gdansk, 80-858, Poland|Krakowskie Centrum Medyczne Sp. z o.o., Krakow, 31-501, Poland|FutureMeds Sp. z o.o. Lodz, Lodz, 91-363, Poland|ETG Lublin, Lublin, 20-412, Poland|Centrum Medyczne "Diabetika", Radom, 26-600, Poland|PANSTWOWY INSTYTUT MEDYCZNY MSWiA, Warszawa, 02-507, Poland|Diabetologicka ambulancia DIASTYLE s.r.o., Banska Bystrica, 97401, Slovakia|Diabetologicka ambulancia DIAMO s.r.o., Kezmarok, 06001, Slovakia|IVAMEDIC s.r.o., Kosice, 040 11, Slovakia|DIA - SANTMART, s.r.o., Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Martin, 036 01, Slovakia|Diabetologicka ambulancia MUDr. Iveta Markova s.r.o, Nitra, 94911, Slovakia|MUDr. Jan Culak, s.r.o., Prievidza, 97101, Slovakia|MEDI-DIA s.r.o., Sabinov, 08301, Slovakia|Medi-Clinic Bloemfontein, Bloemfontein, Free State, 9301, South Africa|Moriana Clinical Research, Brandfort, Free State, 9400, South Africa|Shop#1 Health Emporium, Midrand, Gauteng, 1685, South Africa|Prinshof Medical Campus, Pretoria, Gauteng, 0002, South Africa|Jongaie Research, Pretoria, Gauteng, 0183, South Africa|Clinical Trial Systems (CTC), Pretoria, Gauteng, 0186, South Africa|Dr A Amod, Durban, KwaZulu-Natal, 4092, South Africa|Precise Clinical Solutions (Pty) Ltd, Durban, KwaZulu-Natal, 4092, South Africa|Dr Pillay's Rooms, Durban, KwaZulu-Natal, 4450, South Africa |
| URL: | https://clinicaltrials.gov/show/NCT05478252 |
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