Oral Combination of Glimepiride/Vildagliptin/Metformin in Patients With T2D and Dual Treatment Failure
NCT ID: NCT04841096
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
162 participants
INTERVENTIONAL
2023-03-21
2024-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A1: Glimepiride (1mg) / Vildagliptin (50mg) / Metformin (500mg).
Tablets, orally, once a day. Initial dose for the first 45 days of intervention.
A1=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg)
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.
Group B1: Glimepiride (1mg) / Vildagliptin (50mg) / Metformin (500mg)
Tablets, orally, once a day. Initial dose for the first 45 days of intervention.
B2=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg)
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.
Group A2: Glimepiride (2mg) / Vildagliptin (50mg) / Metformin (1000mg)
Tablets, orally, once a day. Dose escalation if the patients meets established criteria.
(A2) Glimepiride/Vildagliptin/Metformin
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.
Group B2: Glimepiride (4mg) / Vildagliptin (50mg) / Metformin (1000mg)
Tablets, orally, once a day. Dose escalation if the patients meets established criteria.
(B2) Glimepiride/Vildagliptin/Metformin
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.
Interventions
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A1=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg)
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)
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/Metformin
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/Metformin
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
Yes
Sponsors
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Laboratorios Silanes S.A. de C.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Salvador Pérez Jaime, M.D
Role: PRINCIPAL_INVESTIGATOR
Centro de Investigación Médica Aguascalientes (Red OSMO)
Juan A Becerra Hernández, M.D
Role: PRINCIPAL_INVESTIGATOR
Centro de Investigación y Avances Médicos Especializados (Red OSMO)
Ana L Flores Barranco, M.D
Role: PRINCIPAL_INVESTIGATOR
Oaxaca Site Management Organization SC. (Red OSMOS)
Abraham S Álvarez, M.D
Role: PRINCIPAL_INVESTIGATOR
Oncológico Potosino (Red OSMO)
Victor C Bohórquez López, M.D
Role: PRINCIPAL_INVESTIGATOR
Mérida Investigación Clínica (Red OSMO)
Locations
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Centro de Investigación y Avances Médicos Especializados
Cancún, Quintana Roo, Mexico
Mérida Investigación Clínica
Mérida, Yucatán, Mexico
Centro de Investigación Médica Aguascalientes
Aguascalientes, , Mexico
Oaxaca Site Management Organization SC.
Oaxaca City, , Mexico
Oncológico Potosino
San Luis Potosí City, , Mexico
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SIL-30013-III-20(1)
Identifier Type: -
Identifier Source: org_study_id
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