NCT02064881

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes

Timeline
Completed

Started Oct 2015

Longer than P75 for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

4.5 years

First QC Date

February 14, 2014

Last Update Submit

January 26, 2018

Conditions

Type 2 Diabetes

Keywords

Postprandial lipemiaDiabetesMetformin glycinateoxidized LDL

Outcome Measures

Primary Outcomes (1)

  • Change in postprandial lipemia at 4 months

    baseline, 4 months

Secondary Outcomes (6)

  • Change in oxidized LDL at 4 months

    baseline, 4 months

  • Change in FGF-21 levels at 4 months

    baseline, 4 months

  • Change in A1C at 4 months

    baseline, 4 months

  • Change in alanine aminotransferase at 4 months

    baseline, 4 months

  • Change in uric acid at 4 months

    baseline, 4 months

  • +1 more secondary outcomes

Study Arms (2)

metformin glycinate

EXPERIMENTAL

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.

Drug: Metformin glycinate

metformin hydrochloride

ACTIVE COMPARATOR

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.

Drug: Metformin Hydrochloride

Interventions

Metformin glycinateDRUG

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) .

Also known as: DMMET-01
metformin glycinate
Metformin HydrochlorideDRUG

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)

Also known as: HCL MET
metformin hydrochloride

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán

Mexico City, Mexico City, 14000, Mexico

RECRUITING

Related Publications (5)

  • 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.

    PMID: 22517736BACKGROUND

  • 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.

    PMID: 9742977BACKGROUND

  • 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.

    PMID: 21471135BACKGROUND

  • 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.

    PMID: 15699279BACKGROUND

  • 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.

    PMID: 21098347BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Francisco J Gómez, Doctor

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 17, 2014

Study Start

October 1, 2015

Primary Completion

April 1, 2020

Study Completion

August 1, 2020

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

ME(1)