Metformin Glycinate on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes
NCT01386671 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 203
Last updated 2018-01-30
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.
Conditions
Interventions
- DRUG
-
Metformin glycinate
Drug: Metformin glycinate 12 months: 1 month,one tablet 1050.6 mg once daily + 11 months, one tablet 1050.6 mg twice daily
- DRUG
-
Metformin hydrochloride
12 months: 1 month, once daily dose of 850 mg (before dinner) and 11 months, twice daily dose 850 mg (before breakfast) + 850 mg (before dinner).
Sponsors & Collaborators
-
Laboratorios Silanes S.A. de C.V.
lead INDUSTRY
Principal Investigators
-
Niels H Wacher, PhD · IMSS
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-06-30
- Primary Completion
- 2016-02-29
- Completion
- 2018-01-31
Countries
- Mexico
Study Locations
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