Evaluating the Glycemic Control wIth Vildagliptin and Metformin Combination Therapy.

Clinision

Overview

To evaluate the changes from baseline in random blood sugar (RBS) and fasting blood sugar (FBS) levels at week 12 in participants receiving Vildagliptin combination with Metformin.

Galvecta Plus is a combination of Vildagliptin and Metformin hydrochloride. Combination drug with complementary mechanisms of action, provides efficacy and allows to reach glycemic targets compared to continuing metformin monotherapy and is used as an oral hypoglycemic in Type II diabetes mellitus that shows potential to achieve better blood glucose without increasing the risk of hypoglycemia, exposing to weight gain and altering common cardiovascular risk factors (hypertension and lipid profile). The fact that Vildagliptin with metformin substantially enhances the incretin effect. Vildagliptin belongs to dipeptidyl peptidase-4 (DPP-4) inhibitor. Inhibition of dipeptidyl peptidase-4 (DPP-4) by Vildagliptin prevents degradation of glucagon-like peptide-1 (GLP-1) and reduces glycaemia in patients with type 2 diabetes mellitus, with low risk for hypoglycemia and no weight gain and metformin is a Biguanides with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycemia.

Study Type

OBSERVATIONAL

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin/VildagliptinDRUG

Vildagliptin belongs to dipeptidyl peptidase-4 (DPP-4) inhibitor. Inhibition of dipeptidyl peptidase-4 (DPP-4) and metformin is a Biguanides.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants diagnosed with type 2 diabetes mellitus (DM). * Patient with HbA1c levels greater than 7.0% who were naïve or were receiving monotherapy with oral hypoglycemic agent were eligible to participate in the study. Exclusion Criteria: * Patient with a history diabetic ketoacidosis, clinically significant liver or renal disease, congestive heart failure requiring pharmacological treatment, coronary artery percutaneous intervention or unstable angina within the past 6 month excluded from study * Participants who are pregnant or with gestational DM * Age over 80 years * Hypersensitivity to any active ingredient.

Outcomes

Primary Outcomes

Change from baseline in Random blood sugar (RBS) and fasting blood sugar (FBS) levels at week 12 in participants receiving Vildagliptin combination with Metformin

To determine the efficacy of vildagliptin/metformin changes from baseline in random blood sugar (RBS) and fasting blood sugar (FBS) levels after 12 weeks of therapy. \[Designated as safety issue: No \]

Time frame: Week 12

Secondary Outcomes

Changes from baseline in HbA1c Levels at Week 12 in participants receiving Vildagliptin combination with Metformin

To determine the efficacy of vildagliptin/metformin changes from baseline in HbA1c levels after 12 weeks of therapy. \[ Designated as safety issue: No \]

Time frame: Week 12

Number of participants experiencing hypoglycemic episodes in the 12 weeks receiving Vildagliptin combination with Metformin.

To evaluate the number of participants experiencing hypoglycemic episodes in the 12 weeks \[ Designated as safety issue: Yes \]

Time frame: Week 12

Number of participants who experienced an Adverse Event

To evaluate the number of participants who experienced an adverse event after 12 weeks of therapy. \[ Designated as safety issue: Yes \]

Time frame: 12 weeks

Data from ClinicalTrials.gov

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