protocolSection identificationModule nctId: NCT06327815, orgStudyIdInfo id: D1690L00149, briefTitle: Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: Study D1690L00149 is a 24-week, multicentre, randomized, parallel, interventional, non-inferiority, open-label study designed to compare the FDC Regimen of Dapagliflozin/Metformin XR with the Dapagliflozin co-administered with Metformin XR in glycemic lowering control, satisfaction and adherence in Chinese patients with T2DM., conditionsModule conditions: Type 2 Diabetes Mellitus (T2DM), designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 632, type: ESTIMATED, armsInterventionsModule interventions name: Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets, interventions name: Dapagliflozin tablets and Metformin HCl extended-release tablets, outcomesModule primaryOutcomes measure: Change in HbA1c from baseline, secondaryOutcomes measure: Proportion of patients achieved HbA1c less than 7.0% from baseline to week 24., secondaryOutcomes measure: Absolute change in FPG from baseline to week 24., secondaryOutcomes measure: Absolute change in PPG from baseline to week 24., secondaryOutcomes measure: The difference in satisfaction scores between 2 groups measured with the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at week 24., secondaryOutcomes measure: The difference in quality of life between 2 groups measured with Diabetes Quality of Life (DQOL) questionnaire at week 12 and week 24., secondaryOutcomes measure: To evaluate the difference in adherence of FDC versus co-administered dual therapy by Morisky Medication Adherence Scale-8 (MMAS-8) questionnaire in Chinese patients with T2DM., otherOutcomes measure: AEs, otherOutcomes measure: SAE, otherOutcomes measure: ADRs, otherOutcomes measure: Temperature, otherOutcomes measure: Systolic and diastolic BP, otherOutcomes measure: Pulse rate, otherOutcomes measure: Respiratory rate, otherOutcomes measure: Weight, otherOutcomes measure: Height, otherOutcomes measure: BMI, otherOutcomes measure: Number of participants with abnormal ECG readings, otherOutcomes measure: Proportion of TITR (Time in Tight Target Range), otherOutcomes measure: TIR (Time In Range), otherOutcomes measure: TBR (Time Below Range), otherOutcomes measure: TAR (Time Above Range), otherOutcomes measure: MAGE (Mean Amplitude of Glycemic Excursion), otherOutcomes measure: SDBG (Standard Deviation of Blood Glucose), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: RECRUITING, city: Beijing, zip: 100020, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wei Fang, zip: 261035, country: China, hasResults: False