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Clinical Trial Details

Trial ID: L2335
Source ID: NCT05268926
Associated Drug: Dapagliflozin 10mg Tab
Title: TreatIng Microalbuminuria Over 24 Weeks in Subjects With or Without Type 2 Diabetes or HYpertension
Acronym: TIMOTHY
Status: TERMINATED
Study Results: NO
Results:
Conditions: Albuminuria
Interventions: DRUG: Dapagliflozin 10Mg Tab|DRUG: Placebo
Outcome Measures: Primary: urinary albumin/creatinine ratio, Change in albuminuria defined as urinary albumin/creatinine ratio: UACR) with dapagliflozin 10mg/d for 24 weeks relative to placebo, 24 weeks | Secondary: systolic and diastolic blood pressure, Change in systolic and diastolic blood pressure: effect of dapagliflozin 10mg/d compared to placebo on change in systolic and diastolic blood pressure, 24 weeks|body weight, change in body weight: effect of dapagliflozin 10mg/d compared to placebo on change in body, 24 weeks|HbA1c, change in HbA1c: effect of dapagliflozin 10mg/day compared to placebo on change in HbA1c, 24 weeks|eGFR, change in eGFR: effect of dapagliflozin 10mg/day compared to placebo on change in eGFR, 24 weeks|change in UACR, difference in proportion of patients with ≥30%, 40%, 50% change in UACR from baseline at week 24.: effect of dapagliflozin 10mg/day compared to placebo on the proportion of patients with ≥30%, 40%, 50% change in UACR, 24 weeks|number of SAE's and AE's, Safety of dapagliflozin vs Placebo: number of SAE's and AE's reported by the subject or investigator if qualified as: reason for discontinuation, volume depletion, fracture, diabetic ketoacidosis, amputation and adverse events leading to amputation, urinary tract infection, genital infections and hypoglycemia, 24 weeks
Sponsor/Collaborators: Sponsor: University Medical Center Groningen | Collaborators: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 9
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-02-03
Completion Date: 2023-02-02
Results First Posted:
Last Update Posted: 2024-04-17
Locations: UMCG, Groningen, Netherlands
URL: https://clinicaltrials.gov/show/NCT05268926