Metformin Glycinate on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to compare the efficacy and safety of Metformin Glycinate versus Metformin Hydrochloride in metabolic control and inflammatory mediators in Mexican type 2 diabetes patients, in a 12 months follow up.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Silanes S.A. de C.V.
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Type 2 diabetes according ADA

• Less than a year of evolution since diagnosis

• Without antihyperglycemic pharmacological treatment

• HbA1c between 6.5% and 9.5%

• Stable weight during the last 6 months

• Body Mass Index ≥ 25 kg/m2 and <35kg/m2.

• Blood pressure ≤ 130/80 mmHg

• Childbearing women under contraceptive treatment

• Signed Informed Consent Form

• Age from 18 to 70 years old

Exclusion Criteria:

• Non-fulfilment treatment in the screening period

• Smoking up to 1 year before the initial examination

• Drugs or alcohol abuse

• Creatinine depuration estimated with MDRD formula using serum creatinine < 90 ml/min/1.72m2

• History of chronic liver disease, ALT or AST ≥ 2 times from the normal superior limit, or GGT ≥ 3 times from the normal superior limit.

• Chronic lung disease, that causes dyspnea equivalent to a functional class ≥3 (NYHA)or that requires oxygen supplementation.

• History or symptoms of coronary artery disease (CAD) or cerebrovascular disease (CVD).

• Drug treatment that interact with biguanides.

• Another chronic diseases that restricts survival or associated with chronic inflammation like: cancer, leukemia, lymphoma, erythematosus lupus, asthma, rheumatoid arthritis or infection for HIV.

• Pregnancy or positive pregnancy test in women under 50 years old or breastfeeding.