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

Laboratorios Silanes

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: (B2) Glimepiride/Vildagliptin/Metformin; Drug: (A2) Glimepiride/Vildagliptin/Metformin; Drug: B2=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg); Drug: A1=Glimepiride / Vildagliptin / Metformin (1 mg/ 50 mg/ 500 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04841096

SIL-30013-III-20(1)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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172 participants in 4 patient groups

Group A1: Glimepiride (1mg) / Vildagliptin (50mg) / Metformin (500mg).

Experimental group

Description:

Tablets, orally, once a day. Initial dose for the first 45 days of intervention.

Treatment:

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

Group B1: Glimepiride (1mg) / Vildagliptin (50mg) / Metformin (500mg)

Experimental group

Description:

Tablets, orally, once a day. Initial dose for the first 45 days of intervention.

Treatment:

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

Group A2: Glimepiride (2mg) / Vildagliptin (50mg) / Metformin (1000mg)

Experimental group

Description:

Tablets, orally, once a day. Dose escalation if the patients meets established criteria.

Treatment:

Drug: (A2) Glimepiride/Vildagliptin/Metformin

Group B2: Glimepiride (4mg) / Vildagliptin (50mg) / Metformin (1000mg)

Experimental group

Description:

Tablets, orally, once a day. Dose escalation if the patients meets established criteria.

Treatment:

Drug: (B2) Glimepiride/Vildagliptin/Metformin