Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT04943692
- Lead Sponsor
- Laboratorios Silanes S.A. de C.V.
- Brief 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 500
- Subjects ≥18 years old.
- Type 2 diabetes according to ADA diagnostic criteria.
- Naive to treatment or who have previously been under oral hypoglycemic treatment (whatever it may be), as long as it has been suspended for a period of ≥6 weeks prior to the start of the study. - HbA1c ≥7.5% and <10.0%.
- In the case of women of childbearing age and with an active sexual life, the use of birth control methods is required; any of the following are accepted: barrier (male or female condom), non-hormonal intrauterine device, or bilateral tubal obstruction.
- That you agree to participate in the study and give written informed consent.
- Patients with known current abuse or dependence (last 2 months) to substances such as alcohol (weekly consumption> 21 units of alcohol in men or> 14 units of alcohol in women) or recreational drugs.
- Body Mass Index <20 kg / m2 and> 35 kg / m2.
- Glomerular filtration estimated with the MDRD (Modification of Diet in Renal Disease) procedure through serum creatinine <60 ml / min / 1.72 m2.
- History of chronic liver disease or ALT (alanine aminotransferase) and / or AST (aspartate aminotransferase) ≥ 2 times the upper limit of normal, or GGT (Gamma glutamyl transpeptidase) ≥3 times the upper limit of normal.
- Chronic lung disease, causing dyspnea equivalent to a functional class ≥3 (NYHA) or requiring oxygen supplementation.
- Use of drugs that interact with biguanides.
- Other chronic diseases that limit survival or are associated with chronic inflammation such as: cancer, leukemia, lymphoma, lupus erythematosus, asthma, rheumatoid arthritis, or HIV (human immunodeficiency virus) infection.
- Pregnancy or positive pregnancy test, as well as women who are breastfeeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B: Metformin hydrochloride 850 mg Metformin Hydrochloride Metformin hydrochloride 850mg Orally twice a day. Group A: Metformin glycinate 1050 mg Metformin glycinate Metformin glycinate 1050 mg Orally twice a day.
- Primary Outcome Measures
Name Time Method Change in HbA1c Baseline, 6 and 12 months Assess change in HbA1c
- Secondary Outcome Measures
Name Time Method Changes in fasting glucose Baseline, 6 and 12 months Determine the change in fasting glucose levels
Changes in insulin levels Baseline, 6 and 12 months Determine the changes in insulin levels
Changes in leptin levels Baseline, 6 and 12 months Determine the changes in leptin levels
Changes in adipokine levels Baseline, 6 and 12 months Determine the changes in adipokine levels
Changes in nitric oxide levels Baseline, 6 and 12 months Determine changes in nitric oxide levels
Change in the 2-hour oral glucose tolerance curve Baseline, 6 and 12 months Determine the change from baseline in the results of the 2-hour oral glucose tolerance curve
Changes to HOMA-IR (Homeostatic model assessment and Insulin resistance Baseline, 6 and 12 months Determine change in HOMA-IR
Changes in body mass index Baseline, 6 and 12 months Determine changes in body mass index
Incidence of adverse events Baseline, 6 and 12 months Determine the incidence of adverse events that occurred during the study.
Changes in proinflammatory cytokine Baseline, 6 and 12 months Determine the changes in proinflammatory cytokine
Changes in levels of MCP-1 (monocyte chemoattractant protein 1) Baseline, 6 and 12 months Determine the changes in levels of MCP-
Changes in C-reactive protein levels Baseline, 6 and 12 months Determine changes in C-reactive protein levels
Trial Locations
- Locations (1)
Laboratorio Silanes, S.A. de C.V.
🇲🇽Mexico City, Mexico