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Clinical Trial Details

Trial ID: L2659
Source ID: NCT06417489
Associated Drug: Combination Therapy
Title: Evaluation of Efficacy and Safety of Combination Therapy of Henagliflozin Proline, Retagliptin and Metformin in New Diagnosed Type 2 Diabetes Patients
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Combination therapy|DRUG: Sequential treatment group
Outcome Measures: Primary: Proportion of subjects with HbA1c<7% at 12w, From enrollment to the end of treatment at 12 weeks | Secondary: The proportion of subjects with HbA1c<7% at week 24, From enrollment to the end of treatment at 24 weeks|The proportion of subjects with HbA1c<6.5% at 12 week, From enrollment to the end of treatment at 12 weeks|The proportion of subjects with HbA1c<6.5% at 24 week, From enrollment to the end of treatment at 24 weeks|Changes in HbA1c compared to baseline at 12 weeks, From enrollment to the end of treatment at 12 weeks|Changes in HbA1c compared to baseline at 24 weeks, From enrollment to the end of treatment at 24 weeks|Changes in fingertip blood glucose (seven point blood glucose spectrum) compared to baseline at 4w, 8w, 12w, and 24w, From enrollment to the end of treatment at 4/8/12/24 weeks|Changes in 2hPPG compared to baseline at 4w, 8w, 12w, and 24w, From enrollment to the end of treatment at 4/8/12/24 weeks|Changes in FBG compared to baseline at 4w, 8w, 12w, and 24w, From enrollment to the end of treatment at 4/8/12/24 weeks|Changes in systolic pressure compared to baseline at 4w, 8w, 12w, and 24w, From enrollment to the end of treatment at 4/8/12/24 weeks|Changes in diastolic pressure compared to baseline at 4w, 8w, 12w, and 24w, From enrollment to the end of treatment at 4/8/12/24 weeks|Changes in body weight compared to baseline at 4w, 8w, 12w, and 24w, From enrollment to the end of treatment at 4/8/12/24 weeks|Changes in waist circumference compared to baseline at 4w, 8w, 12w, and 24w, From enrollment to the end of treatment at 4/8/12/24 weeks|Changes in eGFR compared to baseline at 4w, 8w, 12w, and 24w, From enrollment to the end of treatment at 4/8/12/24 weeks|Changes in C-peptide levels during the 12 and 24 weeks compared to baseline during abdominal and 2-hour postprandial periods, From enrollment to the end of treatment at 12 and 24 weeks|Changes in insulin levels during the 12 and 24 weeks compared to baseline during abdominal and 2-hour postprandial periods, From enrollment to the end of treatment at 12 and 24 weeks
Sponsor/Collaborators: Sponsor: Peking University First Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 160
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-31
Completion Date: 2026-12-31
Results First Posted:
Last Update Posted: 2024-05-16
Locations:
URL: https://clinicaltrials.gov/show/NCT06417489