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Clinical Trial Details

Trial ID: L2845
Source ID: NCT04564872
Associated Drug: Hsk7653 10 Mg Q2w
Title: HSK7653 Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: HSK7653 10 mg Q2W|DRUG: HSK7653 25 mg Q2W|DRUG: Linagliptin 5 mg QD
Outcome Measures: Primary: HbA1c Change From Baseline at Week 24, Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24, Baseline and week 24 | Secondary: Incidence of Treatment-Emergent Adverse Events, The incidence of Treatment-Emergent Adverse Events over time (at week 24 and week 52), Baseline, week 24 and week 52|Percentage of Patients With HbA1c <7.0%, Baseline, week 24 and week 52|Percentage of Patients With HbA1c <6.5%, Baseline, week 24 and week 52|FPG Change From Baseline at Week 24 and Week 52, Baseline , week 24 and week 52|2h-PPG Change From Baseline at Week 24 and Week 52, Baseline, week 24 and week 52|Weight Change From Baseline at Week 24 and Week 52, Baseline, week 24 and week 52|Fasting C-peptide Change From Baseline at Week 24 and Week 52, Baseline, week 24 and week 52|Insulin Sensitivity Change (Calculated by HOMA-IS) From Baseline at Week 24 and Week 52, Baseline, week 24 and week 52|Pancreatic β-cell function Change (Calculated by HOMA-β) From Baseline at Week 24 and Week 52, Baseline, week 24 and week 52|Percentage of Patients Required Use of Rescue Therapy or Dropout due to Hyperglycemia and Week 52, Baseline, week 24 and week 52
Sponsor/Collaborators: Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 465
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2020-11-13
Completion Date: 2022-08-29
Results First Posted:
Last Update Posted: 2022-12-12
Locations: Peking University People's Hospital, Beijing, Beijing, 100044, China|Inner Mongolia Baogang Hospital, Baotou, Inner Mongolia, China
URL: https://clinicaltrials.gov/show/NCT04564872