Status:
UNKNOWN
Co-administration of Thiamine Pyrophosphate and Metformin in Type 2 Diabetes
Lead Sponsor:
Laboratorios Manuell SA
Collaborating Sponsors:
Universidad Nacional Autonoma de Mexico
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chronic non-infectious diseases have a bigger impact and a higher prevalence every day world-wide. Among them, diabetes stands out being the number one cause of death from degenerative chronic illness...
Eligibility Criteria
Inclusion
- signed informed consent
- diagnosed type 2 diabetes mellitus
- HbA1c between 7.5 and 11%
- monotherapy treatment with metformin at tolerated successful dose
Exclusion
- glomerular filtration rate \<60 ml/min/1.73m2
- cardiac o respiratory insufficiency
- liver enzymes 3 times higher than normal parameters
- known allergy to metformin or thiamine pyrophosphate
- pregnancy, lactation or fertile age without a contraceptive method
- participation in another study in the last 6 months
- programmed surgery for the next 4 months
- treatment with any other hypoglycemic agents
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04053621
Start Date
January 1 2021
End Date
March 1 2022
Last Update
October 22 2020
Active Locations (1)
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1
Centro Especializado en Diabetes, Obesidad, Prevención y Enfermedades Cardiovasculares, S.C.
Mexico City, Mexico City, Mexico, 11650