Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

Comparison of Empaglifozin and Vildagliptin in Efficacy and Safety in Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05359432
• Other study ID #: AK_01
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: August 18, 2021

Study information

• Verified date: April 2022
• Source: Getz Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background: Diabetes is a rampant disease that keeps on getting more and more people affected each year. Over 200 million people have been affected worldwide due to this disorder, and many have contracted various cardiovascular complications due to uncontrolled diabetes. Though an easily manageable disease, if left untreated, diabetes can be fatal. Therefore, it is necessary to have drugs available which control diabetes and also limit the progression of complications that could arise due to it. Objective: 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 Methods: open labelled, multi-centric, parallel, randomized control trial to be conducted at the Department of Diabetes & Endocrinology of two tertiary care hospitals in Karachi, Pakistan. The Participants will undergo screening and then were randomized into two groups. The first group received empagliflozin (10 mg once or twice daily), and the second group received vildagliptin (50 mg once or twice daily. HbA1c, High-density lipoprotein (HDL) levels., Systolic blood pressure, fasting blood glucose, and body weight will be measured at both the baseline and 24-week visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 18, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

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 Exclusion Criteria: 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Empagliflozin
Receiving allocated drug dosage as per clinical needs
• Vildagliptin
Receiving allocated drug dosage as per clinical needs

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Getz Pharma

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2005 Jan;28 Suppl 1:S37-42. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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, 9(th) edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10. — View Citation

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. Epub 2006 Apr 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated hemoglobin A1c (HbA1c)		24 weeks
Primary	High-density lipoprotein (HDL) levels		24 weeks
Primary	Systolic blood pressure		24 weeks
Primary	Fasting blood sugars		24 weeks
Primary	Bodyweight		24 weeks
Primary	Serum creatinine		24 weeks
Primary	Serum glutamic-pyruvic transaminase (SGPT)		24 weeks
Primary	Low-density lipoprotein cholesterol		24 weeks
Primary	Total cholesterols		24 weeks
Primary	Serum triglycerides		24 weeks