Evaluating the Glycemic Control wIth Vildagliptin and Metformin Combination Therapy.

NCT03577184 | Withdrawn FDA Drug

• 1 other identifier: CN/PK/GRIP/SP/2017-01
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

GRIP, DM

Outcome Measures

Primary Outcomes (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

  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 Outcomes (3)

• Changes from baseline in HbA1c Levels at Week 12 in participants receiving Vildagliptin combination with Metformin

  Week 12

• Number of participants experiencing hypoglycemic episodes in the 12 weeks receiving Vildagliptin combination with Metformin.

  Week 12

• Number of participants who experienced an Adverse Event

  12 weeks

Interventions

Metformin/Vildagliptin DRUG

Vildagliptin belongs to dipeptidyl peptidase-4 (DPP-4) inhibitor. Inhibition of dipeptidyl peptidase-4 (DPP-4) and metformin is a Biguanides.

Also known as: Galvecta Plus

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetes Mellitus patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinision: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Nitriles; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: July 5, 2018
• Study Start: July 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: October 3, 2019

Record last verified: 2018-01