Evaluating the Glycemic Control wIth Vildagliptin and Metformin Combination Therapy. (GRIP)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Metformin/Vildagliptin

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diabetes Mellitus patients

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 ]	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 ]	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 ]	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 ]	12 weeks

Collaborators and Investigators

• Sponsor: Clinision

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (ACTUAL): July 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: GRIP, DM
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Vildagliptin
• Other Study ID Numbers: CN/PK/GRIP/SP/2017-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No