Type 2 Diabetes Clinical Trial
Official title:
Comparison of Empaglifozin and Vildagliptin in Efficacy and Safety in Type 2 Diabetes Mellitus
NCT number | NCT05359432 |
Other study ID # | AK_01 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | July 1, 2020 |
Est. completion date | August 18, 2021 |
Verified date | April 2022 |
Source | Getz Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Getz Pharma |
Pakistan,
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
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 |
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