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Safety and Efficacy of Metformin Glycinate vs Metformin Hydrochloride on Metabolic Control and Inflammatory Mediators in DM2 Patients

Phase 3
18 Years
70 Years
Not Enrolling
Type 2 Diabetes

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Trial Information

Safety and Efficacy of Metformin Glycinate vs Metformin Hydrochloride on Metabolic Control and Inflammatory Mediators in DM2 Patients

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 drug
naïve type 2 diabetes patients.

Inclusion Criteria:

- Type 2 diabetes according ADA

- Less than a year of evolution since diagnosis

- Antihyperglycemic pharmacological treatment

- HbA1c between 7.1% and 9.0%

- 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

- Drugs or alcohol abuse

- Creatinine depuration estimated with MDRD formula using serum creatinine < 90

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Glycosylated hemoglobin (HbA1c)

Outcome Description:

HbA1c: Measured by electrophoresis of lacked total blood using Paragon system and Appraise reader 44800 (Beckman Instruments de Mexico). Fasting Glucose: in serum using glucose oxidase technique with BM/Hitachi 704/911 automated analyzer

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Niels H Wacher, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Mexico: Federal Commission for Sanitary Risks Protection

Study ID:




Start Date:

August 2011

Completion Date:

February 2014

Related Keywords:

  • Type 2 Diabetes
  • Type 2 Diabetes
  • metformin glycinate
  • metabolic control
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2