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Clinical Trial Details

Trial ID: L4393
Source ID: NCT03794336
Associated Drug: Alogliptin
Title: Efficacy and Safety of Alogliptin vs. Acarbose in Chinese Type 2 Diabetes Mellitus (T2DM) Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive
Acronym: ACADEMIC
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Alogliptin|DRUG: Acarbose|DRUG: Metformin|DRUG: Aspirin
Outcome Measures: Primary: Change in Hemoglobin A1c, Change from baseline in Hemoglobin A1c at the end of study (week 16) between the two drugs, Baseline to week 16|Overall Gastrointestinal tolerability, Incidence of any gastrointestinal adverse events during the whole treatment period., Baseline to week 16 | Secondary: Percentage of patients achieving HbA1c <7%, Percentage of patients achieving HbA1c \<7% at the end of study, Baseline to Week 16|Percentage of patients achieving HbA1c <7% without gastrointestinal effects, Percentage of patients achieving HbA1c \<7% without gastrointestinal effects at the end of study, Baseline to Week 16|Change in Fasting Plasma Glucose (FPG), Change in FPG from baseline to week 16 between the two groups of drugs, Baseline to Week 16|Occurrence of hypoglycemia events, Number of patients reporting hypoglycemia events, Baseline to Week 16|Other Adverse Events (AEs), Number of patients reporting other Adverse Events, Baseline to Week 16|Overall tolerability, Percentage of patients who discontinued study treatment as a result of adverse drug reaction, Baseline to Week 16|Change in Postprandial Plasma Glucose 2-h (PPG), Change in PPG from baseline to week 16 between two groups of drug, Baseline to Week 16|Change in Homeostasis model assessment-β (HOMA- β), Change in HOMA- β from baseline to week 16 between two groups of drug, Baseline to Week 16|Change in Total Cholesterol (TC), Changes from baseline in TC to week 16 between the two groups, Baseline to Week 16|Change in Tri Glycerides (TG), Changes from baseline in TG to week 16 between the two groups, Baseline to Week 16|Change in High Density Lipoprotein-Cholesterol (HDL-C), Changes from baseline in HDL-C to week 16 between the two groups, Baseline to Week 16|Change in Low Density Lipoprotein-Cholesterol (LDL-C), Changes from baseline in LDL-C to week 16 between the two groups., Baseline to Week 16|Change in body weight, Changes from baseline in body weight to week 16 between the two groups, Baseline to Week 16|Overall adherence to Investigational Medicinal Product (IMP), Calculated as overall dosing actually taken IMPs divided by the expected overall dosing as per protocol, Baseline to Week 16|Medication possession ratio (MPR), Calculated as number of days actually taken IMPs divided by the expected number of days as per protocol, Baseline to Week 16
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 1293
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-06-29
Completion Date: 2020-12-14
Results First Posted:
Last Update Posted: 2022-04-25
Locations: CHINA, China, China
URL: https://clinicaltrials.gov/show/NCT03794336