Clinical trial NCT04943692: Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes
Official title: Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Diabetes
Metformin glycinate
Metformin hydrochloride
fasting glucose
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2021-06-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: Baseline, 6 and 12 months
Secondary outcomes:
measure: Changes in fasting glucose
timeFrame: Baseline, 6 and 12 months
measure: Change in the 2-hour oral glucose tolerance curve
timeFrame: Baseline, 6 and 12 months
measure: Changes to HOMA-IR (Homeostatic model assessment and Insulin resistance
timeFrame: Baseline, 6 and 12 months
measure: Changes in insulin levels
timeFrame: Baseline, 6 and 12 months
measure: Changes in leptin levels
timeFrame: Baseline, 6 and 12 months
measure: Changes in adipokine levels
timeFrame: Baseline, 6 and 12 months
measure: Changes in proinflammatory cytokine
timeFrame: Baseline, 6 and 12 months
measure: Changes in levels of MCP-1 (monocyte chemoattractant protein 1)
timeFrame: Baseline, 6 and 12 months
measure: Changes in nitric oxide levels
timeFrame: Baseline, 6 and 12 months
measure: Changes in C-reactive protein levels
timeFrame: Baseline, 6 and 12 months
measure: Changes in body mass index
timeFrame: Baseline, 6 and 12 months
measure: Incidence of adverse events
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Laboratorio Silanes, S.A. de C.V.
Study officials:
affiliation: Clinica integral del paciente diabético y obeso
name: Guillermo Fanghänel Salmón, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de terapéutica experimental y clínica (INTEC)
name: Manuel González Ortiz, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Resultados médicos, desarrollo e investigación SC. (REMEDI)
name: Joel Rodríguez Saldaña, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigación Biomédica para el Desarrollo de Fármacos, S.A de C.V. (IBIOMED-GDL)
name: María L Sánchez Aldana Robles, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Independent
name: Francisco G Padilla Padilla, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Villa Coapa La Vereda S.C.
name: Jorge V Yamamoto Cuevas, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (IBIOMED-AGS)
name: Edmundo D Ríos Mejía, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Hispanos S.A. de C.V.
name: Luis M Román Pintos, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Oaxaca Site Management Organization SC. (Red OSMO)
name: Víctor Bohórquez López, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Investigación Médica Aguascalientes (Red OSMO)
name: Santiago P Ramírez Díaz, M..D
role: PRINCIPAL_INVESTIGATOR
affiliation: Mérida Investigación Clínica (Red OSMO)
name: José De la Cruz Tun Pech, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de endocrinología Hospital Univertsitario, UANL
name: Fernando J Lavalle González, M.D
role: PRINCIPAL_INVESTIGATOR
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