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CompletedNCT01386671COMETUpdated Jan 30, 2018

Metformin Glycinate on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes

A Phase 3 interventional study of Metformin glycinate and Metformin hydrochloride in Type 2 Diabetes, sponsored by Laboratorios Silanes S.A. de C.V.. Completed at 4 sites in Mexico. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by Laboratorios Silanes S.A. de C.V. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
203
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The aim of this study is to compare the efficacy and safety of Metformin Glycinate versus Metformin Hydrochloride in metabolic control and inflammatory mediators in Mexican type 2 diabetes patients, in a 12 months follow up.

Read the detailed description

Metformin glycinate salt is a new drug , which has better pharmacokinetic characteristics (better bioavailability and absorption) making a proper antihyperglycemic power without increasing the frequency of adverse effects. The drug has been tested in preclinical test with animals, in healthy subjects and in patients with type 2 diabetes; which showed that it has adequate antihyperglycemic effect. Now, its important to compare metformin glycinate and metformin hydrochloride for evaluate the relative antihyperglicemic power. In addition, a study with a larger number of patients improve the statistical power of the test to investigate the effects of these drugs on possible weight loss and lipid profile improve. Additionally, it will also explore the relative power of the two medications tested to modify inflammatory response mediators and oxidative stress have been associated with the incidence of cardiovascular disease in diabetes. This project was designed with the intent to answer the next question: What are the efficacy and safety of metformin glycinate dose of 2101.2 mg/day (equivalent to 1700 mg/day metformin hydrochloride), compared with metformin hydrochloride in doses of 1700 mg/day for 12 months of treatment in patients with Type 2 diabetes.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Type 2 Diabetes
  • metformin glycinate
  • metabolic control
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 203 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Laboratorios Silanes S.A. de C.V. is the lead sponsor of 43 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 diabetes according ADA
  • Less than a year of evolution since diagnosis
  • Without antihyperglycemic pharmacological treatment
  • HbA1c between 6.5% and 9.5%
  • Stable weight during the last 6 months
  • Body Mass Index ≥ 25 kg/m2 and \<35kg/m2.
  • Blood pressure ≤ 130/80 mmHg
  • Childbearing women under contraceptive treatment
  • Signed Informed Consent Form
  • Age from 18 to 70 years old

Exclusion criteria

Exclusion Criteria:

  • Non-fulfilment treatment in the screening period
  • Smoking up to 1 year before the initial examination
  • Drugs or alcohol abuse
  • Creatinine depuration estimated with MDRD formula using serum creatinine \< 90 ml/min/1.72m2
  • History of chronic liver disease, ALT or AST ≥ 2 times from the normal superior limit, or GGT ≥ 3 times from the normal superior limit.
  • Chronic lung disease, that causes dyspnea equivalent to a functional class ≥3 (NYHA)or that requires oxygen supplementation.
  • History or symptoms of coronary artery disease (CAD) or cerebrovascular disease (CVD).
  • Drug treatment that interact with biguanides.
  • Another chronic diseases that restricts survival or associated with chronic inflammation like: cancer, leukemia, lymphoma, erythematosus lupus, asthma, rheumatoid arthritis or infection for HIV.
  • Pregnancy or positive pregnancy test in women under 50 years old or breastfeeding.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
203 participants (actual)

Study arms

  • Experimental
    Metformin glycinate

    Metformin glycinate is a new biguanide, for this study the dose administrated will be 1050.6 mg OD for a month, and 1050.6 mg BID for 11 moths.

    Drug: Metformin glycinate

  • Active comparator
    Metformin Hydrochloride

    Metformin Hydrochloride is the biguanide most used, for this study the dose administrated will be 850 mg OD for a month, and 850 mg BID for 11 months.

    Drug: Metformin hydrochloride

Interventions

  • DrugMetformin glycinate

    Drug: Metformin glycinate 12 months: 1 month,one tablet 1050.6 mg once daily + 11 months, one tablet 1050.6 mg twice daily

  • DrugMetformin hydrochloride

    12 months: 1 month, once daily dose of 850 mg (before dinner) and 11 months, twice daily dose 850 mg (before breakfast) + 850 mg (before dinner).

    Also known as: Predial

06

What researchers measure

Primary outcomes

  1. Glycosylated hemoglobin (HbA1c)

    HbA1c: Measured by electrophoresis of lacked total blood using Paragon system and Appraise reader 44800 (Beckman Instruments de Mexico). Fasting Glucose: in serum using glucose oxidase technique with BM/Hitachi 704/911 automated analyzer

    Time frame: 12 months

Secondary outcomes

  1. Fasting glucose

    Time frame: 12 months

  2. Total cholesterol

    Time frame: 12 months

  3. High-density lipoprotein (HDL)

    Time frame: 12 months

  4. Low-density lipoprotein (LDL)

    Time frame: 12 months

  5. Triglycerides

    Time frame: 12 months

  6. Tumor necrosis factor-alpha (TNF-α)

    Time frame: 12 months

  7. Adiponectin

    Time frame: 12 months

  8. Resistin

    Time frame: 12 months

  9. Interleukin-1 beta (IL-1β)

    Time frame: 12 months

  10. Number of Adverse Events as a Measure of Safety and Tolerability

    Time frame: 12 months

  11. Malonylaldehyde

    Time frame: 12 months

  12. Dismutase superoxide

    Time frame: 12 months

07

Study locations

4 sites
  • Unidad Antidiabética Integral
    Mexico City, AA 06600, Mexico
  • Paracelsus S.A. de C.V.
    Mexico, city, AA 03800, Mexico
  • Unidad de Investigacion en Epidemiologia Clinica. UMAE Hospital de Especialidades Centro Medico Nacional Siglo XXI. Instituto Mexicano del Seguro Social
    Mexico City, Distrito Federal 06720, Mexico
  • Instituto de terapéutica experimental y clínica (INTEC)
    Guadalajara, Jalisco 44600, Mexico
08

References and documents

Publications

  • Hermann LS, Schersten B, Melander A. Antihyperglycaemic efficacy, response prediction and dose-response relations of treatment with metformin and sulphonylurea, alone and in primary combination. Diabet Med. 1994 Dec;11(10):953-60. doi: 10.1111/j.1464-5491.1994.tb00253.x. PubMed 7895460 ↗
  • Johnson JA, Simpson SH, Toth EL, Majumdar SR. Reduced cardiovascular morbidity and mortality associated with metformin use in subjects with Type 2 diabetes. Diabet Med. 2005 Apr;22(4):497-502. doi: 10.1111/j.1464-5491.2005.01448.x. PubMed 15787679 ↗
  • Phung OJ, Scholle JM, Talwar M, Coleman CI. Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. JAMA. 2010 Apr 14;303(14):1410-8. doi: 10.1001/jama.2010.405. PubMed 20388897 ↗
  • 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. PubMed 9742977 ↗
  • Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10. PubMed 18784090 ↗
  • Tzoulaki I, Molokhia M, Curcin V, Little MP, Millett CJ, Ng A, Hughes RI, Khunti K, Wilkins MR, Majeed A, Elliott P. Risk of cardiovascular disease and all cause mortality among patients with type 2 diabetes prescribed oral antidiabetes drugs: retrospective cohort study using UK general practice research database. BMJ. 2009 Dec 3;339:b4731. doi: 10.1136/bmj.b4731. PubMed 19959591 ↗
  • Selvin E, Bolen S, Yeh HC, Wiley C, Wilson LM, Marinopoulos SS, Feldman L, Vassy J, Wilson R, Bass EB, Brancati FL. Cardiovascular outcomes in trials of oral diabetes medications: a systematic review. Arch Intern Med. 2008 Oct 27;168(19):2070-80. doi: 10.1001/archinte.168.19.2070. PubMed 18955635 ↗
  • Alexander GC, Sehgal NL, Moloney RM, Stafford RS. National trends in treatment of type 2 diabetes mellitus, 1994-2007. Arch Intern Med. 2008 Oct 27;168(19):2088-94. doi: 10.1001/archinte.168.19.2088. PubMed 18955637 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01386671
Lead sponsor
Laboratorios Silanes S.A. de C.V.
Responsible party
Sponsor
First posted
Jul 1, 2011
Start date
Jun 2014
Primary completion
Feb 2016
Completion
Jan 2018
Last update
Jan 30, 2018

Study contacts

Niels H Wacher, PhD
principal investigator · IMSS

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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