AzTrials
AzTrials

Type 2 DiabetesPhase 3COMETNCT01386671

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

A Phase 3 study testing Metformin glycinate and Metformin hydrochloride in people with Type 2 Diabetes, run by Laboratorios Silanes S.A. de C.V. at 4 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Metformin glycinate and Metformin hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
4 sitesMexico
Study dates
Jun 2014to Jan 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • Blood pressure ≤ 130/80 mmHg
  • Childbearing women under contraceptive treatment
  • Signed Informed Consent Form
  • Age from 18 to 70 years old

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

Mexico4 sites

  • Instituto de terapéutica experimental y clínica (INTEC)

    Guadalajara, Jalisco, 44600

  • Paracelsus S.A. de C.V.

    Mexico City, AA, 03800

  • Unidad Antidiabética Integral

    Mexico City, AA, 06600

  • Unidad de Investigacion en Epidemiologia Clinica. UMAE Hospital de Especialidades Centro Medico Nacional Siglo XXI. Instituto Mexicano del Seguro Social

    Mexico City, Mexico City, 06720

Other trials in Mexico

About this study

Official title: Safety and Efficacy of Metformin Glycinate vs Metformin Hydrochloride on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes Patients

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.

Conditions
Type 2 Diabetes
Being tested
Metformin glycinate, Metformin hydrochloride
Keywords
Type 2 Diabetes, metformin glycinate, metabolic control
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metformin glycinateDrug

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

  • Metformin hydrochlorideDrug

    Also called Predial

    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).

Study groups in NCT01386671
Study groupRoleWhat they receive
Metformin glycinateExperimentalMetformin 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.
Receives: Drug: Metformin glycinate
Metformin HydrochlorideActive comparatorMetformin 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.
Receives: Drug: Metformin hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (12)

  1. Fasting glucose

    Measured: 12 months

  2. Total cholesterol

    Measured: 12 months

  3. High-density lipoprotein (HDL)

    Measured: 12 months

  4. Low-density lipoprotein (LDL)

    Measured: 12 months

  5. Triglycerides

    Measured: 12 months

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

    Measured: 12 months

  7. Adiponectin

    Measured: 12 months

  8. Resistin

    Measured: 12 months

  9. Interleukin-1 beta (IL-1β)

    Measured: 12 months

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

    Measured: 12 months

  11. Malonylaldehyde

    Measured: 12 months

  12. Dismutase superoxide

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2011 (estimated)
  2. Study startJun 2014
  3. Primary completionFeb 2016
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01386671
Sponsor's protocol ID
GlyMet01_13062011
Acronym
COMET
Status last verified
Jan 2018
First submitted
29 Jun 2011
Last updated
30 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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.

    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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin glycinate and Metformin hydrochloride in people with Type 2 Diabetes, run by Laboratorios Silanes S.A. de C.V. at 4 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycosylated hemoglobin (HbA1c) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01386671, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in