NCT04943692

Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Phase III study to evaluate the efficacy and safety of the treatment. Two-arm, prospective, longitudinal, double-blind, multicenter randomized clinical trial.

Detailed description

Study to evaluate the efficacy and safety of treatment at 6 and 12 months with metformin glycinate at a dose of 2100 mg / day compared to metformin hydrochloride at a dose of 1700 mg / day on the progression of type 2 diabetes. To assess the change in HbA1c from baseline to 6 and 12 months of treatment (primary endpoint) in both groups. As secondary objectives, changes in fasting glucose levels from baseline, changes in results of the oral glucose tolerance test 2h from baseline, changes in HOMA-IR from baseline, changes in insulin levels, leptin, adipokines and proinflammatory cytokines, MCP-1, nitric oxide and PCr from baseline, changes in BMI from baseline and changes in lipid profile from baseline will be evaluated. A blinded interim analysis will be performed at 6 months of patient follow-up and a final analysis. Demographic data will be analyzed with mean, standard deviation, minimum and maximum. Efficacy analyzes will be carried out in the treated population (all treated patients, ATP), made up of all randomized patients who received at least one dose of the study treatment and who have a baseline measurement and at least one subsequent measurement.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Metformin glycinate	1050 mg, tablets Administered orally, twice a day, for 12 months.
DRUG	Metformin Hydrochloride	850 mg, tablets. Administered orally, twice a day, for 12 months.

Timeline

• Start date: 2021-08-01
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2021-06-29
• Last updated: 2021-06-29

Locations

1 site across 1 country: Mexico