Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes

NCT04943692 | Suspended Phase 3

• 1 other identifier: SIL-30000-III-19(1)
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Phase III study to evaluate the efficacy and safety of the treatment. Two-arm, prospective, longitudinal, double-blind, multicenter randomized clinical trial.

Conditions

Type 2 Diabetes

Keywords

Diabetes; Metformin glycinate; Metformin hydrochloride; fasting glucose

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Assess change in HbA1c

  Baseline, 6 and 12 months

Secondary Outcomes (12)

• Changes in fasting glucose

  Baseline, 6 and 12 months

• Change in the 2-hour oral glucose tolerance curve

  Baseline, 6 and 12 months

• Changes to HOMA-IR (Homeostatic model assessment and Insulin resistance

  Baseline, 6 and 12 months

• Changes in insulin levels

  Baseline, 6 and 12 months

• Changes in leptin levels

  Baseline, 6 and 12 months

Study Arms (2)

Group A: Metformin glycinate 1050 mg

EXPERIMENTAL

Metformin glycinate 1050 mg Orally twice a day.

Drug: Metformin glycinate

Group B: Metformin hydrochloride 850 mg

ACTIVE COMPARATOR

Metformin hydrochloride 850mg Orally twice a day.

Drug: Metformin Hydrochloride

Interventions

Metformin glycinate DRUG

1050 mg, tablets Administered orally, twice a day, for 12 months.

Also known as: MET GLY

Group A: Metformin glycinate 1050 mg

Metformin Hydrochloride DRUG

850 mg, tablets. Administered orally, twice a day, for 12 months.

Also known as: MET HYD

Group B: Metformin hydrochloride 850 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Laboratorio Silanes, S.A. de C.V.

Mexico City, 11000, Mexico

Location

Related Publications (28)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

methionylglycine; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Guillermo Fanghänel Salmón, M.D

  Clinica integral del paciente diabético y obeso

  PRINCIPAL INVESTIGATOR

• Manuel González Ortiz, M.D

  Instituto de terapéutica experimental y clínica (INTEC)

  PRINCIPAL INVESTIGATOR

• Joel Rodríguez Saldaña, M.D

  Resultados médicos, desarrollo e investigación SC. (REMEDI)

  PRINCIPAL INVESTIGATOR

• María L Sánchez Aldana Robles, M.D

  Investigación Biomédica para el Desarrollo de Fármacos, S.A de C.V. (IBIOMED-GDL)

  PRINCIPAL INVESTIGATOR

• Francisco G Padilla Padilla, M.D

  Independent

  PRINCIPAL INVESTIGATOR

• Jorge V Yamamoto Cuevas, M.D

  Clínica Villa Coapa La Vereda S.C.

  PRINCIPAL INVESTIGATOR

• Edmundo D Ríos Mejía, M.D

  Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (IBIOMED-AGS)

  PRINCIPAL INVESTIGATOR

• Luis M Román Pintos, M.D

  Hospital Hispanos S.A. de C.V.

  PRINCIPAL INVESTIGATOR

• Víctor Bohórquez López, M.D

  Oaxaca Site Management Organization SC. (Red OSMO)

  PRINCIPAL INVESTIGATOR

• Santiago P Ramírez Díaz, M..D

  Centro de Investigación Médica Aguascalientes (Red OSMO)

  PRINCIPAL INVESTIGATOR

• José De la Cruz Tun Pech, M.D

  Mérida Investigación Clínica (Red OSMO)

  PRINCIPAL INVESTIGATOR

• Fernando J Lavalle González, M.D

  Servicio de endocrinología Hospital Univertsitario, UANL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)