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

• ClinicalTrials.gov Identifier: NCT03577184
• Recruitment Status: Withdrawn
• First Posted: July 5, 2018
• Last Update Posted: October 3, 2019
• Sponsor: Clinision
• Information provided by (Responsible Party): Clinision

Study Description

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.

Condition or disease	Intervention/treatment
Diabetes Mellitus, Type 2	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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Effect of Vildagliptin & Metformin Combination on Glycemic Control and Hypoglycemic Episodes. An Observational Real Life Trial
• Estimated Study Start Date: July 2018
• Estimated Primary Completion Date: December 2018
• Estimated Study Completion Date: March 2019

Groups and Cohorts

Intervention Details:

• Drug: Metformin/Vildagliptin
  Vildagliptin belongs to dipeptidyl peptidase-4 (DPP-4) inhibitor. Inhibition of dipeptidyl peptidase-4 (DPP-4) and metformin is a Biguanides.
  Other Name: Galvecta Plus

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in Random blood sugar (RBS) and fasting blood sugar (FBS) levels at week 12 in participants receiving Vildagliptin combination with Metformin [ Time Frame: 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 Outcome Measures :

1. Changes from baseline in HbA1c Levels at Week 12 in participants receiving Vildagliptin combination with Metformin [ Time Frame: 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 ]

2. Number of participants experiencing hypoglycemic episodes in the 12 weeks receiving Vildagliptin combination with Metformin. [ Time Frame: Week 12 ]
   To evaluate the number of participants experiencing hypoglycemic episodes in the 12 weeks [ Designated as safety issue: Yes ]
3. Number of participants who experienced an Adverse Event [ Time Frame: 12 weeks ]

   To evaluate the number of participants who experienced an adverse event after 12 weeks of therapy.

   [ Designated as safety issue: Yes ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Diabetes Mellitus patients

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Clinision
• ClinicalTrials.gov Identifier: NCT03577184
• Other Study ID Numbers: CN/PK/GRIP/SP/2017-01
• First Posted: July 5, 2018
• Last Update Posted: October 3, 2019
• Last Verified: January 2018

• 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

Keywords provided by Clinision:

GRIP, DM

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Metformin; Vildagliptin; Hypoglycemic Agents; Physiological Effects of Drugs; Dipeptidyl-Peptidase IV Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action