Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4296
Source ID: NCT05833958
Associated Drug: Gmrx-4 Ir Polypill - Sitagliptin, Dapagliflozin, Metformin
Title: Polypill Versus Metformin in New Onset Type 2 Diabetes
Acronym: PiVOT
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: GMRx-4 IR polypill - sitagliptin, dapagliflozin, metformin|DRUG: Metformin|DRUG: Metformin
Outcome Measures: Primary: Change in glycosylated haemoglobin (HbA1c), Change in glycosylated haemoglobin (HbA1c) from baseline to 16 weeks, 16 weeks | Secondary: Change in fasting plasma glucose, Change in fasting plasma glucose from baseline to 16 weeks, 16 weeks|Change in cholesterol, Change in fasting total cholesterol, LDL-cholesterol and HDL-cholesterol from baseline to 16 weeks, 16 weeks|Change in triglycerides, Change in fasting triglycerides from baseline to 16 weeks, 16 weeks|Change in blood pressure, Change in systolic and diastolic blood pressure from baseline to 16 weeks, 16 weeks|Change in weight in kilograms, Change in weight from baseline to 16 weeks, 16 weeks|Medication adherence, Medication adherence throughout the trial. Adherence will be assessed by self-report surveys entered directly into the ePRO platform (eCRF)., 16 weeks|Medication tolerability, Medication tolerability throughout the trial (based on permanent drug cessation due to side effects and incidence of reported side effects). Tolerability will be assessed by recording of adverse effects into self-report surveys, and adverse events identified by the Investigator during study contacts, entered directly into the ePRO platform (eCRF)., 16 weeks
Sponsor/Collaborators: Sponsor: George Medicines PTY Limited | Collaborators: Brandon Biocatalyst|The George Institute
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-09
Results First Posted:
Last Update Posted: 2024-09-19
Locations:
URL: https://clinicaltrials.gov/show/NCT05833958