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Type 2 DiabetesPhase 3NCT04841096

Oral Combination of Glimepiride/Vildagliptin/Metformin in Patients With T2D and Dual Treatment Failure

A Phase 3 study testing A1=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg), B2=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg) and (A2) Glimepiride/Vildagliptin/Metformin in people with Type 2 Diabetes, run by Laboratorios Silanes S.A. de C.V. at 5 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

Phase IIIb, randomized, multicenter, double-blind, prospective study to evaluate the efficacy and safety of a daily fixed-dose combination of glimepiride / vildagliptin / metformin in patients with type 2 diabetes with a history of dual treatment failure and combined or individual oral antidiabetics with SGLT2 /… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes
What is being tested?
A1=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg), B2=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg) and (A2) Glimepiride/Vildagliptin/Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
5 sitesMexico
Study dates
21 Mar 2023to 15 May 2024
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or Female.
  • Age >18 years old at the beginning of the study.
  • Diagnosis of type 2 diabetes prior to the start of the study.
  • Therapeutic failure to a dual treatment with SGLT2 / Metformin, Biguanide / Sulfonylurea, Sulfonylurea / iDPP4, Biguanide / iDPP4.
  • HbA1c ≥ 7.5% and ≤ 11% during screening tests.
  • Women of childbearing potential using a contraceptive method (barrier, oral hormonal, injectable, subdermal) or naturally or surgically sterile in menopause.
  • Subject agree to participate in the study and give informed consent in writing.

Who cannot join

  • The drug is contraindicated for medical reasons.
  • History of Type 1 Diabetes Mellitus.
  • History of metabolic complications such as ketoacidosis or nonketotic hyperosmolar state.
  • History of gastric bariatric surgery or gastric band in the last year.
  • History of drug or alcohol abuse in the past year.
  • Body Mass Index <20 kg/m2 and >40 kg/m2.
Show all 12Show fewer
  • Acute or severe renal dysfunction (glomerular filtration <30 ml / min / 1.72 m2).
  • History of chronic liver disease or ALT and / or AST ≥3 times the normal upper limit and / or Total Bilirubin> 2.5 times the upper limit of normal, or GGT ≥3 times the upper limit of normal.
  • Pregnant and / or lactating women.
  • The patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.
  • At medical criteria, a disease that affects the prognosis and prevents outpatient management, for example, but not restricted to: end-stage cancer, kidney, heart, respiratory or liver failure, mental illness, with scheduled surgical or hospital procedures.
  • Be a patient with a working relationship with the main researcher or the research center or deprived of liberty.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Mexico5 sites

  • Centro de Investigación Médica Aguascalientes

    Aguascalientes, 20116

  • Centro de Investigación y Avances Médicos Especializados

    Cancún, Quintana Roo, 77506

  • Mérida Investigación Clínica

    Mérida, Yucatán, 97125

  • Oaxaca Site Management Organization SC.

    Oaxaca City, 68000

  • Oncológico Potosino

    San Luis Potosí City, 78250

Other trials in Mexico

About this study

Official title: Efficacy and Safety of the Oral Combined Therapy Glimepiride / Vildagliptin / Metformin in Patients With Type 2 Diabetes With Dual Treatment Failure

Phase IIIb, randomized, multicenter, double-blind, prospective study to evaluate the efficacy and safety of a daily fixed-dose combination of glimepiride / vildagliptin / metformin in patients with type 2 diabetes with a history of dual treatment failure and combined or individual oral antidiabetics with SGLT2 / Metformin, Biguanide / Sulfonylurea, Sulfonylurea / iDPP4 or Biguanide / iDPP4. To evaluate the changes in the percentage of HbA1c at 3 and 6 months with regard to their baseline measurement.

Read the detailed description

To achieve glycemic control goals, a combination of medications with complementary mechanisms of action, with fasting and postprandial effects, may be required to achieve and maintain clinically acceptable glycemic control in some patients. A fixed combination of two or more therapeutic agents with complementary mechanisms of action makes it possible to optimize compliance and adherence to treatment among patients with T2D because it is administered once a day with the same efficacy of the separate components, but with fewer gastrointestinal effects. This is reflected in a reduction in HA1c and a lower evolution to long-term complications of T2D. Phase IIIb, randomized, multicenter, double-blind, prospective study to evaluate the efficacy and safety of a daily fixed-dose combination of glimepiride / vildagliptin / metformin in patients with type 2 diabetes with a history of dual treatment failure and combined or individual oral antidiabetics with SGLT2 / Metformin, Biguanide / Sulfonylurea, Sulfonylurea / iDPP4 or Biguanide / iDPP4.

Conditions
Type 2 Diabetes
Being tested
A1=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg), B2=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg), (A2) Glimepiride/Vildagliptin/Metformin, (B2) Glimepiride/Vildagliptin/Metformin
Keywords
Type 2 diabetes, Combine therapy, Hypoglycemic agents
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.

  • A1=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg)Drug

    Also called (A1) Glimepiride/Vildagliptin/Metformin

    Take one tablet of the prescribed dose of the investigational drug by mouth, preferably with food and in the morning. Initial dose for the first 45 days of intervention.

  • B2=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg)Drug

    Also called (B1) Glimepiride/Vildagliptin/Metformin

    take one tablet of the prescribed dose of the investigational drug by mouth, preferably with food and in the morning. Initial dose for the first 45 days of intervention.

  • (A2) Glimepiride/Vildagliptin/MetforminDrug

    Also called A2=Glimepiride / Vildagliptin / Metformin (2 mg/ 50 mg/ 1000 mg)

    Take one tablet of the prescribed dose of the investigational drug by mouth, preferably with food and in the morning. Escalation dose in cause the patient meets established criteria.

  • (B2) Glimepiride/Vildagliptin/MetforminDrug

    Also called B2=Glimepiride / Vildagliptin / Metformin (4 mg/ 50 mg/ 1000 mg)

    Take one tablet of the prescribed dose of the investigational drug by mouth, preferably with food and in the morning. Escalation dose in cause the patient meets established criteria.

Study groups in NCT04841096
Study groupRoleWhat they receive
Group A1: Glimepiride (1mg) / Vildagliptin (50mg) / Metformin (500mg).ExperimentalTablets, orally, once a day. Initial dose for the first 45 days of intervention.
Receives: Drug: A1=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg)
Group B1: Glimepiride (1mg) / Vildagliptin (50mg) / Metformin (500mg)ExperimentalTablets, orally, once a day. Initial dose for the first 45 days of intervention.
Receives: Drug: B2=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg)
Group A2: Glimepiride (2mg) / Vildagliptin (50mg) / Metformin (1000mg)ExperimentalTablets, orally, once a day. Dose escalation if the patients meets established criteria.
Receives: Drug: (A2) Glimepiride/Vildagliptin/Metformin
Group B2: Glimepiride (4mg) / Vildagliptin (50mg) / Metformin (1000mg)ExperimentalTablets, orally, once a day. Dose escalation if the patients meets established criteria.
Receives: Drug: (B2) Glimepiride/Vildagliptin/Metformin

What is being measured

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

  1. Compare changes in HbA1

    Mean change in HbA1c

    Measured: baseline, 3 and 6 months of treatment

  2. Proportion of patients who change their HbA1c concentration

    Proportion of patients who change their HbA1c by at least 1 percent

    Measured: baseline, 3 and 6 months of treatment

  3. Mean difference change between groups in HbA1c concentration

    Difference greater than 0.3 between group A and B HbA1c concentration

    Measured: baseline, 3 and 6 months of treatment

Secondary outcomes (2)

  1. Mean glucose change

    Compare changes in glucose between baseline, 3 and 6 months of treatment

    Measured: baseline, 3 and 6 months of treatment

  2. Incidence of adverse events and reactions

    Description of al the adverse events and reactions presented during the study

    Measured: baseline, 3 and 6 months of treatment

Timeline

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

  1. First posted12 Apr 2021
  2. Study start21 Mar 2023
  3. Primary completion15 Mar 2024
  4. Study completion15 May 2024

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
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04841096
Sponsor's protocol ID
SIL-30013-III-20(1)
Status last verified
Jun 2025
First submitted
6 Apr 2021
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S14-S31. doi: 10.2337/dc20-S002.

    PubMed 31862745

  • Cahn A, Raz I, Kleinman Y, Balicer R, Hoshen M, Lieberman N, Brenig N, Del Prato S, Cefalu WT. Clinical Assessment of Individualized Glycemic Goals in Patients With Type 2 Diabetes: Formulation of an Algorithm Based on a Survey Among Leading Worldwide Diabetologists. Diabetes Care. 2015 Dec;38(12):2293-300. doi: 10.2337/dc15-0187. Epub 2015 Oct 30.

    PubMed 26519337

  • Cramer JA. A systematic review of adherence with medications for diabetes. Diabetes Care. 2004 May;27(5):1218-24. doi: 10.2337/diacare.27.5.1218.

    PubMed 15111553

  • Rubin RR. Adherence to pharmacologic therapy in patients with type 2 diabetes mellitus. Am J Med. 2005 May;118 Suppl 5A:27S-34S. doi: 10.1016/j.amjmed.2005.04.012.

    PubMed 15850551

  • Khunti K, Kosiborod M, Ray KK. Legacy benefits of blood glucose, blood pressure and lipid control in individuals with diabetes and cardiovascular disease: Time to overcome multifactorial therapeutic inertia? Diabetes Obes Metab. 2018 Jun;20(6):1337-1341. doi: 10.1111/dom.13243. Epub 2018 Mar 11.

    PubMed 29405543

  • Orozco-Beltran D, Mata-Cases M, Artola S, Conthe P, Mediavilla J, Miranda C. [Adherence of Type 2 Diabetes Mellitus approach: Current situation and possible solutions]. Aten Primaria. 2016 Jun-Jul;48(6):406-20. doi: 10.1016/j.aprim.2015.09.001. Epub 2016 Jan 13. Spanish.

    PubMed 26775266

  • Garber AJ, Handelsman Y, Grunberger G, Einhorn D, Abrahamson MJ, Barzilay JI, Blonde L, Bush MA, DeFronzo RA, Garber JR, Garvey WT, Hirsch IB, Jellinger PS, McGill JB, Mechanick JI, Perreault L, Rosenblit PD, Samson S, Umpierrez GE. CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM - 2020 EXECUTIVE SUMMARY. Endocr Pract. 2020 Jan;26(1):107-139. doi: 10.4158/CS-2019-0472. No abstract available.

    PubMed 32022600

  • Lukashevich V, Del Prato S, Araga M, Kothny W. Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea. Diabetes Obes Metab. 2014 May;16(5):403-9. doi: 10.1111/dom.12229. Epub 2013 Dec 2.

    PubMed 24199686

  • Maruthur NM, Tseng E, Hutfless S, Wilson LM, Suarez-Cuervo C, Berger Z, Chu Y, Iyoha E, Segal JB, Bolen S. Diabetes Medications as Monotherapy or Metformin-Based Combination Therapy for Type 2 Diabetes: A Systematic Review and Meta-analysis. Ann Intern Med. 2016 Jun 7;164(11):740-51. doi: 10.7326/M15-2650. Epub 2016 Apr 19.

    PubMed 27088241

  • Dennis JM, Henley WE, Weedon MN, Lonergan M, Rodgers LR, Jones AG, Hamilton WT, Sattar N, Janmohamed S, Holman RR, Pearson ER, Shields BM, Hattersley AT; MASTERMIND Consortium. Sex and BMI Alter the Benefits and Risks of Sulfonylureas and Thiazolidinediones in Type 2 Diabetes: A Framework for Evaluating Stratification Using Routine Clinical and Individual Trial Data. Diabetes Care. 2018 Sep;41(9):1844-1853. doi: 10.2337/dc18-0344. Epub 2018 Aug 2.

    PubMed 30072404

  • Bianchi C, Daniele G, Dardano A, Miccoli R, Del Prato S. Early Combination Therapy with Oral Glucose-Lowering Agents in Type 2 Diabetes. Drugs. 2017 Mar;77(3):247-264. doi: 10.1007/s40265-017-0694-4.

    PubMed 28155046

  • U.K. prospective diabetes study 16. Overview of 6 years' therapy of type II diabetes: a progressive disease. U.K. Prospective Diabetes Study Group. Diabetes. 1995 Nov;44(11):1249-58.

    PubMed 7589820

  • Levy J, Atkinson AB, Bell PM, McCance DR, Hadden DR. Beta-cell deterioration determines the onset and rate of progression of secondary dietary failure in type 2 diabetes mellitus: the 10-year follow-up of the Belfast Diet Study. Diabet Med. 1998 Apr;15(4):290-6. doi: 10.1002/(SICI)1096-9136(199804)15:43.0.CO;2-M.

    PubMed 9585393

  • Benford M, Milligan G, Pike J, Anderson P, Piercy J, Fermer S. Fixed-dose combination antidiabetic therapy: real-world factors associated with prescribing choices and relationship with patient satisfaction and compliance. Adv Ther. 2012 Jan;29(1):26-40. doi: 10.1007/s12325-011-0096-z. Epub 2012 Jan 12.

    PubMed 22246944

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing A1=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg), B2=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg) and (A2) Glimepiride/Vildagliptin/Metformin in people with Type 2 Diabetes, run by Laboratorios Silanes S.A. de C.V. at 5 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 7 inclusion and 12 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 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Compare changes in HbA1 (time frame: baseline, 3 and 6 months of treatment). The study lists 3 primary outcomes in all. 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 NCT04841096, which also lists 14 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 10 Jun 2025.

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