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

October 30, 2023 updated by: Laboratorios Silanes S.A. de C.V.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Aguascalientes, Mexico, 20116
        • Recruiting
        • Centro de Investigacion Medica Aguascalientes
        • Contact:
          • Salvador Pérez Jaime, M.D
          • Phone Number: 449 994 9458
      • Oaxaca, Mexico, 68000
        • Not yet recruiting
        • Oaxaca Site Management Organization SC.
        • Contact:
          • Ana L Flores Barranco, M.D
          • Phone Number: 951 514 7056
      • San Luis Potosí, Mexico, 78250
        • Not yet recruiting
        • Oncológico Potosino
        • Contact:
          • Abraham S Álvarez, M.D
          • Phone Number: 444 139 7700
    • Quintana Roo
      • Cancún, Quintana Roo, Mexico, 77506
        • Not yet recruiting
        • Centro de Investigación y Avances Médicos Especializados
        • Contact:
          • Juan A Becerra Hernández, M.D
          • Phone Number: 998 138 2821
    • Yucatan
      • Merida, Yucatan, Mexico, 97125
        • Not yet recruiting
        • Mérida Investigación Clínica
        • Contact:
          • Victor C Bohórquez López, M.D
          • Phone Number: 999 688 9735

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A1: Glimepiride (1mg) / Vildagliptin (50mg) / Metformin (500mg).
Tablets, orally, once a day. Initial dose for the first 45 days of intervention.
Drug: 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.
Other Names:
  • (A1) Glimepiride/Vildagliptin/Metformin
Experimental: Group B1: Glimepiride (1mg) / Vildagliptin (50mg) / Metformin (500mg)
Tablets, orally, once a day. Initial dose for the first 45 days of intervention.
Drug: 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.
Other Names:
  • (B1) Glimepiride/Vildagliptin/Metformin
Experimental: Group A2: Glimepiride (2mg) / Vildagliptin (50mg) / Metformin (1000mg)
Tablets, orally, once a day. Dose escalation if the patients meets established criteria.
Drug: (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.
Other Names:
  • A2=Glimepiride / Vildagliptin / Metformin (2 mg/ 50 mg/ 1000 mg)
Experimental: Group B2: Glimepiride (4mg) / Vildagliptin (50mg) / Metformin (1000mg)
Tablets, orally, once a day. Dose escalation if the patients meets established criteria.
Drug: (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 Names:
  • B2=Glimepiride / Vildagliptin / Metformin (4 mg/ 50 mg/ 1000 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare changes in HbA1
Time Frame: baseline, 3 and 6 months of treatment
Mean change in HbA1c
baseline, 3 and 6 months of treatment
Proportion of patients who change their HbA1c concentration
Time Frame: baseline, 3 and 6 months of treatment
Proportion of patients who change their HbA1c by at least 1 percent
baseline, 3 and 6 months of treatment
Mean difference change between groups in HbA1c concentration
Time Frame: baseline, 3 and 6 months of treatment
Difference greater than 0.3 between group A and B HbA1c concentration
baseline, 3 and 6 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean glucose change
Time Frame: baseline, 3 and 6 months of treatment
Compare changes in glucose between baseline, 3 and 6 months of treatment
baseline, 3 and 6 months of treatment
Incidence of adverse events and reactions
Time Frame: baseline, 3 and 6 months of treatment
Description of al the adverse events and reactions presented during the study
baseline, 3 and 6 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Silanes S.A. de C.V.

Investigators

  • Principal Investigator: Salvador Pérez Jaime, M.D, Centro de Investigación Médica Aguascalientes (Red OSMO)
  • Principal Investigator: Juan A Becerra Hernández, M.D, Centro de Investigación y Avances Médicos Especializados (Red OSMO)
  • Principal Investigator: Ana L Flores Barranco, M.D, Oaxaca Site Management Organization SC. (Red OSMOS)
  • Principal Investigator: Abraham S Álvarez, M.D, Oncológico Potosino (Red OSMO)
  • Principal Investigator: Victor C Bohórquez López, M.D, Mérida Investigación Clínica (Red OSMO)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIL-30013-III-20(1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on A1=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe