Diabetes Mellitus, Type 2
Conditions
Keywords
GRIP, DM
Brief 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.
Interventions
DRUGMetformin/Vildagliptin
Vildagliptin belongs to dipeptidyl peptidase-4 (DPP-4) inhibitor. Inhibition of dipeptidyl peptidase-4 (DPP-4) and metformin is a Biguanides.
Sponsors
Clinision
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Random blood sugar (RBS) and fasting blood sugar (FBS) levels at week 12 in participants receiving Vildagliptin combination with Metformin | Week 12 | 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. \[Designated as safety issue: No \] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in HbA1c Levels at Week 12 in participants receiving Vildagliptin combination with Metformin | Week 12 | To determine the efficacy of vildagliptin/metformin changes from baseline in HbA1c levels after 12 weeks of therapy. \[ Designated as safety issue: No \] |
| Number of participants experiencing hypoglycemic episodes in the 12 weeks receiving Vildagliptin combination with Metformin. | Week 12 | To evaluate the number of participants experiencing hypoglycemic episodes in the 12 weeks \[ Designated as safety issue: Yes \] |
| Number of participants who experienced an Adverse Event | 12 weeks | To evaluate the number of participants who experienced an adverse event after 12 weeks of therapy. \[ Designated as safety issue: Yes \] |
Outcome results
None listed