Effect of Imeglimin on Blood Glucose Variability

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2022
INTERVENTION: If the patient is taking oral hypoglycemic agents other than DPP‐4 inhibitors, washout for at least 8 weeks, and oral imeglimin (1000 mg twice daily) or metformin (250 mg twice daily for the first 8 weeks, increasing to 500 mg twice daily after the first 8 weeks) for 20 weeks. CONDITION: Type 2 diabetes mellitus PRIMARY OUTCOME: Change in glycemic index (Time in Range [TIR]) by CGM from 0‐2 weeks to 16‐18 weeks after randomization in the imeglimine group SECONDARY OUTCOME: (Efficacy endpoints); Change in glycemic indices and glycemic variability indices by CGM from 0‐2 weeks to 16‐18 weeks after randomization and change in HbA1c, 8‐OHd G, HOMA‐IR, HOMA‐beta, adiponection and lipid metabolism indices (TC, HDL‐C, LDL‐C, TG, FFA) and weight from baseline to each measurement point in the imegurimine and metformin groups; ; (Safety endpoints) ; 1) Adverse events; 2) Side effects; 3) Serious adverse events; 4) Noteworthy adverse events INCLUSION CRITERIA: 1) Patients who have been diagnosed with type 2 diabetes at the time of obtaining consent 2) Patients who are between 20 and 75 years of age at the time of consent. 3) Patients whose HbA1c level measured at the time of eligibility test is between 6.5% and 9.5%. 4) Patients with a body mass inde X(BMI) of 18.5 k g/m2 or higher at the time of the eligibility test. 5) Patients who have given written consent to participate in this clinical study.
Epistemonikos ID: f1f05b9603aa0ce1b146f23c62d5f8bf0edbcf86
First added on: Aug 26, 2024