Clinical trial NCT03577184: Evaluating the Glycemic Control wIth Vildagliptin and Metformin Combination Therapy.
Official title: Effect of Vildagliptin & Metformin Combination on Glycemic Control and Hypoglycemic Episodes. An Observational Real Life Trial
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes Mellitus, Type 2
Keywords: GRIP, DM
Lead sponsor: Clinision
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetes Mellitus patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Random blood sugar (RBS) and fasting blood sugar (FBS) levels at week 12 in participants receiving Vildagliptin combination with Metformin
timeFrame: Week 12
Secondary outcomes:
measure: Changes from baseline in HbA1c Levels at Week 12 in participants receiving Vildagliptin combination with Metformin
timeFrame: Week 12
measure: Number of participants experiencing hypoglycemic episodes in the 12 weeks receiving Vildagliptin combination with Metformin.
timeFrame: Week 12
measure: Number of participants who experienced an Adverse Event
timeFrame: 12 weeks
Other outcomes:
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