Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus

NCT05359432 | Completed Phase 4

• 1 other identifier: AK_01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with Type 2 Diabetes Mellitus open labelled, multi-centric, parallel, randomized control trial In Type 2 Diabetes patients, impact of empagliflozin (10 mg once or twice daily) versus vildagliptin (50 mg once or twice daily) assessed for Efficacy \& safety parameters to be measured at both the baseline and 24-week visits.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes Mellitus; Empagliflozin; Vildagliptin; Efficacy; Safety

Outcome Measures

Primary Outcomes (10)

• Glycosylated hemoglobin A1c (HbA1c)

  24 weeks

• High-density lipoprotein (HDL) levels

  24 weeks

• Systolic blood pressure

  24 weeks

• Fasting blood sugars

  24 weeks

• Bodyweight

  24 weeks

• Serum creatinine

  24 weeks

• Serum glutamic-pyruvic transaminase (SGPT)

  24 weeks

• Low-density lipoprotein cholesterol

  24 weeks

• Total cholesterols

  24 weeks

• Serum triglycerides

  24 weeks

Study Arms (2)

Empagliflozin

EXPERIMENTAL

Drug: Empagliflozin

Vildagliptin

EXPERIMENTAL

Drug: Vildagliptin

Interventions

Empagliflozin DRUG

Receiving allocated drug dosage as per clinical needs

Empagliflozin

Vildagliptin DRUG

Receiving allocated drug dosage as per clinical needs

Vildagliptin

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and Male Patients of age 30-65 years with confirmed diagnosis of "type 2 diabetes mellitus".
• Uncontrolled type 2 diabetes mellitus (\> 7% HbA1c patients on monotherapy of metformin for the past three months on a fixed dose of 1500 mg /day along with lifestyle modifications were included in this study.
• BMI ranges from 18-45 kg/m2 were considered fit for this study. eGFR ≥ 60 ml/min/1.73 m2

You may not qualify if:

• Pregnant female or female patients planning to conceive during the study period were excluded from this study.
• "Type 1 diabetes" or "secondary diabetes" resulting from specific causes Patients with advanced diabetic complications. Patients with any other terminal disease(s) requiring long-term medications. Patients involved in other trials on therapy with SGLT-2i or DPP4-I 3 months before study enrollment Patients on insulin or any other oral hypoglycemic drugs except metformin. Serum creatinine levels ≥ 1.3 mg/dl in women and ≥ 1.4 mg/dl in men

Sponsors & Collaborators

• Getz Pharma: lead

Study Sites (1)

Department of Diabetes and Endocrinology at Sindh Government Hospital New Karachi & Dr. Riasat Medical Center Allah Wala Town, Karachi, Pakistan

Karachi, Sindh, 75330, Pakistan

Location

Related Publications (5)

• Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.

  PMID: 31518657 BACKGROUND

• Deshpande AD, Harris-Hayes M, Schootman M. Epidemiology of diabetes and diabetes-related complications. Phys Ther. 2008 Nov;88(11):1254-64. doi: 10.2522/ptj.20080020. Epub 2008 Sep 18.

  PMID: 18801858 BACKGROUND

• American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2005 Jan;28 Suppl 1:S37-42. doi: 10.2337/diacare.28.suppl_1.s37. No abstract available.

  PMID: 15618111 BACKGROUND

• Strodl E, Kenardy J. Psychosocial and non-psychosocial risk factors for the new diagnosis of diabetes in elderly women. Diabetes Res Clin Pract. 2006 Oct;74(1):57-65. doi: 10.1016/j.diabres.2006.02.011. Epub 2006 Apr 11.

  PMID: 16584801 BACKGROUND

• Lin YK, Gao B, Liu L, Ang L, Mizokami-Stout K, Pop-Busui R, Zhang L. The Prevalence of Diabetic Microvascular Complications in China and the USA. Curr Diab Rep. 2021 Apr 9;21(6):16. doi: 10.1007/s11892-021-01387-3.

  PMID: 33835284 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin; Vildagliptin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Asima Niazi

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 3, 2022
• Study Start: July 1, 2020
• Primary Completion: August 10, 2021
• Study Completion: August 18, 2021
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: In 1 month for 1 year

Locations

PA (1)