Type 2 Diabetes
Conditions
Keywords
Diabetes, Metformin glycinate, Metformin hydrochloride, fasting glucose
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.
Interventions
1050 mg, tablets Administered orally, twice a day, for 12 months.
DRUGMetformin Hydrochloride
850 mg, tablets. Administered orally, twice a day, for 12 months.
Sponsors
Laboratorios Silanes S.A. de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Baseline, 6 and 12 months | Assess change in HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 fasting glucose | Baseline, 6 and 12 months | Determine the change in fasting glucose levels |
| Changes in levels of MCP-1 (monocyte chemoattractant protein 1) | Baseline, 6 and 12 months | Determine the changes in levels of MCP- |
| Changes in nitric oxide levels | Baseline, 6 and 12 months | Determine changes in nitric oxide levels |
| Changes in C-reactive protein levels | Baseline, 6 and 12 months | Determine changes in C-reactive protein levels |
| 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 |
Countries
Mexico
Outcome results
None listed