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

Type 2 Diabetes Clinical Trial

— COMETII  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04943692
• Other study ID #: SIL-30000-III-19(1)
• Status: Suspended
• Phase: Phase 3
• Start date: August 2021
• Est. completion date: August 2021

Study information

• Verified date: June 2021
• Source: Laboratorios Silanes S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 500
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Metformin glycinate
1050 mg, tablets Administered orally, twice a day, for 12 months.
• Metformin Hydrochloride
850 mg, tablets. Administered orally, twice a day, for 12 months.

Locations

Country	Name	City	State
Mexico	Laboratorio Silanes, S.A. de C.V.	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Silanes S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Assess change in HbA1c	Baseline, 6 and 12 months
Secondary	Changes in fasting glucose	Determine the change in fasting glucose levels	Baseline, 6 and 12 months
Secondary	Change in the 2-hour oral glucose tolerance curve	Determine the change from baseline in the results of the 2-hour oral glucose tolerance curve	Baseline, 6 and 12 months
Secondary	Changes to HOMA-IR (Homeostatic model assessment and Insulin resistance	Determine change in HOMA-IR	Baseline, 6 and 12 months
Secondary	Changes in insulin levels	Determine the changes in insulin levels	Baseline, 6 and 12 months
Secondary	Changes in leptin levels	Determine the changes in leptin levels	Baseline, 6 and 12 months
Secondary	Changes in adipokine levels	Determine the changes in adipokine levels	Baseline, 6 and 12 months
Secondary	Changes in proinflammatory cytokine	Determine the changes in proinflammatory cytokine	Baseline, 6 and 12 months
Secondary	Changes in levels of MCP-1 (monocyte chemoattractant protein 1)	Determine the changes in levels of MCP-	Baseline, 6 and 12 months
Secondary	Changes in nitric oxide levels	Determine changes in nitric oxide levels	Baseline, 6 and 12 months
Secondary	Changes in C-reactive protein levels	Determine changes in C-reactive protein levels	Baseline, 6 and 12 months
Secondary	Changes in body mass index	Determine changes in body mass index	Baseline, 6 and 12 months
Secondary	Incidence of adverse events	Determine the incidence of adverse events that occurred during the study.	Baseline, 6 and 12 months