Efficacy Study of Metformin Glycinate on Postprandial Lipemia

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02064881
• Other study ID #: DMMET_LP001
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 14, 2014
• Last updated: January 26, 2018
• Start date: October 2015
• Est. completion date: August 2020

Study information

• Verified date: January 2018
• Source: Laboratorios Silanes S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: August 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Metformin glycinate
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) .
• Metformin Hydrochloride
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)

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán	México	Distrito Federal

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorios Silanes S.A. de C.V.	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

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. — View 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. Review. Erratum in: Diabetes Care. 2013 Feb;36(2):490. — View 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. — View 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. — View Citation

Schramm TK, Gislason GH, Vaag A, Rasmussen JN, Folke F, Hansen ML, Fosbøl EL, Køber 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postprandial lipemia at 4 months		baseline, 4 months
Secondary	Change in oxidized LDL at 4 months		baseline, 4 months
Secondary	Change in FGF-21 levels at 4 months		baseline, 4 months
Secondary	Change in A1C at 4 months		baseline, 4 months
Secondary	Change in alanine aminotransferase at 4 months		baseline, 4 months
Secondary	Change in uric acid at 4 months		baseline, 4 months
Secondary	Number of Participants with Serious and Non-Serious Adverse Events		up to 4 months