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Efficacy Study of Metformin Glycinate on Postprandial Lipemia

Primary Purpose

Type 2 Diabetes

Status

Unknown status

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

Metformin glycinate

Metformin Hydrochloride

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Postprandial lipemia, Diabetes, Metformin glycinate, oxidized LDL

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients of both sexes
Between 35 and 65 years old
Patients with type 2 diabetes within two years of diagnosis according to the ADA criteria
Overweight patients (BMI between 25.5 and 29.9 kg/m2) or with grade 1 obesity (BMI between 30.0 and 34.9 kg/m2), according to WHO classification
Low HDL levels: <50 in women and <40 mg/dL in men
Hypertriglyceridemia: >150 and less than 300 mg/dL
Patients who had not taken antidiabetes drug treatment or with diet and exercise treatment, or with metformin or DPP4 inhibitor monotherapy
HbA1c between 6.5 and 8.5%.
Creatinine clearance >60 ml/min (calculated by Cockcroft and Gault)
Informed consent form signed.
Women using contraception.

Exclusion Criteria:

Patients with other types of diabetes (type 1, LADA, MODY, etc.).
Patients with primary dyslipidemia.
Patients with poorly substituted hypothyroidism TSH > 5 mU/mL.
Patients hospitalized in the last month.
Patients with a disease of poor short-term prognosis
Patients with autoimmune or rheumatic diseases.
Patients with acute infection or febrile illness.
History of chronic liver disease or ALT or AST ≥ 2.0 times the upper limit of normal, or GGT ≥ 3 times the upper limit of normal.
Patients with any other chronic disease, for example: HIV, rheumatic diseases.
Pregnant or positive pregnancy test.
Women who are breastfeeding.
Patients in another research project.

Sites / Locations

Instituto Nacional de Ciencias Médicas Y Nutrición Salvador ZubiránRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

metformin glycinate

metformin hydrochloride

Arm Description

620mg tablets of metformin glycinate: 1 tablet by mouth at night for 3 days, 1 tablet in the morning and evening for 3 days, 1 tablet in the morning and 2 tablets in the evening for 3 days and 2 tablets in the evening and 2 tablets in the morning until the end of the study. Total study dose: 1240mg every 12 hours.

500mg tablets of metformin hydrochloride:1 tablet by mouth at night for 3 days, 1 tablet in the morning and evening for 3 days, 1 tablet in the morning and 2 tablets in the evening for 3 days and 2 tablets in the evening and 2 tablets in the morning until the end of the study. Total study dose: 1000mg every 12 hours.

Outcomes

Primary Outcome Measures

Change in postprandial lipemia at 4 months

Secondary Outcome Measures

Change in oxidized LDL at 4 months

Change in FGF-21 levels at 4 months

Change in A1C at 4 months

Change in alanine aminotransferase at 4 months

Change in uric acid at 4 months

Number of Participants with Serious and Non-Serious Adverse Events

Full Information

NCT ID

NCT02064881

First Posted

February 14, 2014

Last Updated

January 26, 2018

Sponsor

Laboratorios Silanes S.A. de C.V.

Collaborators

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

1. Study Identification

Unique Protocol Identification Number

NCT02064881

Brief Title

Efficacy Study of Metformin Glycinate on Postprandial Lipemia

Official Title

Effect of Metformin Glycinate on Postprandial Lipemia, Glycemic Control and Oxidation Markers in Type 2 Diabetes Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 2015 (undefined)

Primary Completion Date

April 2020 (Anticipated)

Study Completion Date

August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratorios Silanes S.A. de C.V.

Collaborators

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to evaluate the effect of metformin glycinate vs metformin hydrochloride on postprandial lipemia. 72 patients will be included, they will be randomized and assigned into one of the two treatment groups: metformin glycinate 1240 mg BID or metformin hydrochloride 1000 mg BID (36 patients per group). The patients will be followed for 4 months. Blood count, blood chemistry, liver profile, lipid profile, HbA1c, apolipoprotein B, oxidized LDL, fibroblast growth factor 21, leptin, adiponectin, C-reactive protein, free fatty acids, fibrinogen, Goodpasture Binding Protein (GPBP) and antioxidant activity of plasma will be measured at baseline and 4 months. Additionally, after a structured meal, the following parameters will be measured: glucose, insulin, triglycerides, apolipoprotein B and oxidized LDL. (baseline and 4 months). Throughout the study adverse events will be documented.

Detailed Description

Main objective: To compare the effect of metformin glycinate with metformin hydrochloride postprandial lipemia (area under the curve of triglycerides) Study group Tablets of 620 mg of metformin glycinate. Scaling: 1 tablet at night for 3 days, followed by 1 tablet in the morning and 1 tablet at night for 3 days, followed by 1 tablet in the morning and 2 tablets in the evening for 3 days and finally, 2 tablets in the morning and 2 tablets in the evening to complete the study. Final study dose 1240 mg every 12 hours. Comparative group 500 mg tablets of metformin hydrochloride. Scaling: 1 tablet at night for 3 days, followed by 1 tablet in the morning and 1 tablet at night for 3 days, followed by 1 tablet in the morning and 2 tablets in the evening for 3 days and finally, 2 tablets in the morning and 2 tablets in the evening to complete the study. Final study dose 1000 mg every 12 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Postprandial lipemia, Diabetes, Metformin glycinate, oxidized LDL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

metformin glycinate

Arm Type

Experimental

Arm Description

Arm Title

metformin hydrochloride

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Metformin glycinate

Other Intervention Name(s)

DMMET-01

Intervention Description

All patients are going to begin the treatment with one tablet orally at night, 30 minutes before dinner (1 tablet of 620 mg glycinate metformin or one 500 mg tablet of metformin hydrochloride) and the dose will be administrated every 3 days to complete the dose of 2 tablets in the morning 30 minutes before breakfast and 2 tablets in the evening 30 minutes before dinner (1240 mg metformin glycinate every 12 hours or 1000 mg metformin hydrochloride every 12 hrs) .

Intervention Type

Drug

Intervention Name(s)

Metformin Hydrochloride

Other Intervention Name(s)

HCL MET

Intervention Description

Primary Outcome Measure Information:

Title

Change in postprandial lipemia at 4 months

Time Frame

baseline, 4 months

Secondary Outcome Measure Information:

Title

Change in oxidized LDL at 4 months

Time Frame

baseline, 4 months

Title

Change in FGF-21 levels at 4 months

Time Frame

baseline, 4 months

Title

Change in A1C at 4 months

Time Frame

baseline, 4 months

Title

Change in alanine aminotransferase at 4 months

Time Frame

baseline, 4 months

Title

Change in uric acid at 4 months

Time Frame

baseline, 4 months

Title

Number of Participants with Serious and Non-Serious Adverse Events

Time Frame

up to 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients of both sexes Between 35 and 65 years old Patients with type 2 diabetes within two years of diagnosis according to the ADA criteria Overweight patients (BMI between 25.5 and 29.9 kg/m2) or with grade 1 obesity (BMI between 30.0 and 34.9 kg/m2), according to WHO classification Low HDL levels: <50 in women and <40 mg/dL in men Hypertriglyceridemia: >150 and less than 300 mg/dL Patients who had not taken antidiabetes drug treatment or with diet and exercise treatment, or with metformin or DPP4 inhibitor monotherapy HbA1c between 6.5 and 8.5%. Creatinine clearance >60 ml/min (calculated by Cockcroft and Gault) Informed consent form signed. Women using contraception. Exclusion Criteria: Patients with other types of diabetes (type 1, LADA, MODY, etc.). Patients with primary dyslipidemia. Patients with poorly substituted hypothyroidism TSH > 5 mU/mL. Patients hospitalized in the last month. Patients with a disease of poor short-term prognosis Patients with autoimmune or rheumatic diseases. Patients with acute infection or febrile illness. History of chronic liver disease or ALT or AST ≥ 2.0 times the upper limit of normal, or GGT ≥ 3 times the upper limit of normal. Patients with any other chronic disease, for example: HIV, rheumatic diseases. Pregnant or positive pregnancy test. Women who are breastfeeding. Patients in another research project.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francisco J Gómez, Doctor

Organizational Affiliation

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán

City

México

State/Province

Distrito Federal

ZIP/Postal Code

14000

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francisco Gómez, Doctor

Phone

55133891

gomezperezfco@gmail.com

First Name & Middle Initial & Last Name & Degree

Paloma Almeda, Doctor

Phone

56554523

palomaalmeda@yahoo.com

First Name & Middle Initial & Last Name & Degree

Francisco J Gómez, Doctor

12. IPD Sharing Statement

Citations:

PubMed Identifier

22517736

Citation

Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012 Jun;35(6):1364-79. doi: 10.2337/dc12-0413. Epub 2012 Apr 19. No abstract available. Erratum In: Diabetes Care. 2013 Feb;36(2):490.

Results Reference

background

PubMed Identifier

9742977

Citation

Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):854-65. Erratum In: Lancet 1998 Nov 7;352(9139):1558.

Results Reference

background

PubMed Identifier

21471135

Citation

Schramm TK, Gislason GH, Vaag A, Rasmussen JN, Folke F, Hansen ML, Fosbol EL, Kober L, Norgaard ML, Madsen M, Hansen PR, Torp-Pedersen C. Mortality and cardiovascular risk associated with different insulin secretagogues compared with metformin in type 2 diabetes, with or without a previous myocardial infarction: a nationwide study. Eur Heart J. 2011 Aug;32(15):1900-8. doi: 10.1093/eurheartj/ehr077. Epub 2011 Apr 6. Erratum In: Eur Heart J. 2012 May;33(10):1183.

Results Reference

background

PubMed Identifier

15699279

Citation

Masoudi FA, Inzucchi SE, Wang Y, Havranek EP, Foody JM, Krumholz HM. Thiazolidinediones, metformin, and outcomes in older patients with diabetes and heart failure: an observational study. Circulation. 2005 Feb 8;111(5):583-90. doi: 10.1161/01.CIR.0000154542.13412.B1.

Results Reference

background

PubMed Identifier

21098347

Citation

Roussel R, Travert F, Pasquet B, Wilson PW, Smith SC Jr, Goto S, Ravaud P, Marre M, Porath A, Bhatt DL, Steg PG; Reduction of Atherothrombosis for Continued Health (REACH) Registry Investigators. Metformin use and mortality among patients with diabetes and atherothrombosis. Arch Intern Med. 2010 Nov 22;170(21):1892-9. doi: 10.1001/archinternmed.2010.409.

Results Reference

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Efficacy Study of Metformin Glycinate on Postprandial Lipemia

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