NCT03577184

Evaluating the Glycemic Control wIth Vildagliptin and Metformin Combination Therapy.

Effect of Vildagliptin & Metformin Combination on Glycemic Control and Hypoglycemic Episodes. An Observational Real Life Trial

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Clinision · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Metformin/Vildagliptin	Vildagliptin belongs to dipeptidyl peptidase-4 (DPP-4) inhibitor. Inhibition of dipeptidyl peptidase-4 (DPP-4) and metformin is a Biguanides.

Timeline

• Start date: 2018-07-01
• Primary completion: 2018-12-01
• Completion: 2019-03-01
• First posted: 2018-07-05
• Last updated: 2019-10-03

Regulatory

• FDA-regulated drug study