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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus T2DM who are already being treated with insulin and other glucose-lowering medications. This Phase III study focuses on adults with T2DM who have had the condition for at least 90 days and meet certain health criteria. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are taken orally once daily. The study treatment period lasts up to 40 weeks, during which participants continue their background insulin and glucose-lowering medications. During the study, participants will have regular assessments to monitor changes in blood sugar control, including Hemoglobin A1c HbA1c, body weight, blood pressure, and insulin dose. Researchers will also track safety, side effects, and tolerability. The main outcome is the change in HbA1c from baseline to Week 40. Overall, participation involves visits for monitoring and evaluations over approximately 40 weeks.

Age: 18Years +All GendersPhase 3
132 locations
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Actively Recruiting

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

Age: 18Years +All GendersPhase 3
282 locations
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Actively Recruiting

Researchers are evaluating the efficacy, safety, and tolerability of a study drug called elecoglipron compared with oral semaglutide in adults with Type 2 Diabetes Mellitus T2DM who have an increased risk of cardiovascular events. The study focuses on adults whose diabetes is not adequately controlled by lifestyle changes or stable treatment with other glucose-lowering medications. This is a phase III randomized trial sponsored by AstraZeneca, aiming to compare these two oral medications in managing T2DM and cardiovascular risk. Participants will be assigned to receive either elecoglipron or semaglutide, both administered orally once daily at specified doses. The study runs in parallel groups, with one group receiving elecoglipron and the other receiving semaglutide. Treatment and observation will continue for 52 weeks, during which the effects on blood sugar control and other health indicators will be evaluated. Throughout the 52-week study period, participants will undergo regular assessments including measurements of Hemoglobin A1c HbA1c, body weight, and blood pressure. Researchers will monitor changes from baseline to week 52 to understand the drugs impact on diabetes control and cardiovascular risk factors. The study also tracks safety and tolerability to ensure participant wellbeing during the trial.

Age: 18Years +All GendersPhase 3
201 locations