Comparing Enavogliflozin and Pioglitazone as Add-ons to Metformin With/Without Dipeptidyl Peptidase-4 Inhibitors in Type 2 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The current study aimed to thoroughly compare a thiazolidinedione and an sodium-glucose cotransporter-2 (SGLT2) inhibitor regarding various clinical issues including atherosclerosis. Enavogliflozin is compared to Pioglitazone in the glucose-lowering effects of adding to the treatment of patients with type 2 diabetes whose HbA1c levels are not controlled by Metformin with or without DPP-4 inhibitors. Additionally, the study will compare changes in other metabolic or cardiovascular risk factors, such as triglycerides, high density lipoprotein cholesterol (HDLc), uric acid, blood pressure, and inflammatory markers, between the two drugs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• Type 2 diabetes patients with a glycated hemoglobin (HbA1c) level of 7.0 - 10.5% at screening

• Males or females aged 20-80 years

• Individuals who have been taking Metformin (≥ 500mg) with or without a DPP-4 inhibitor (such as Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Gemigliptin, Alogliptin, Teneligliptin, Anagliptin, Evogliptin) for at least the past 3 months

• Body mass index ≥ 23 kg/m²

• Estimated glomerular filtration ratio (eGFR) ≥ 60 ml/min/1.73m²

Locations
Other Locations
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Contact Information
Primary
Soo Lim, M.D. Ph.D.
limsoo@snu.ac.kr
+82317877035
Backup
Minji Sohn, Ph.D.
rainbowmjs@naver.com
+82317878443
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 120
Treatments
Experimental: Enavogliflozin
Enavogliflozin 0.3 mg
Active_comparator: Pioglitazone
Pioglitazone 15 mg
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Bundang Hospital
Collaborators: Daewoong Pharmaceutical Co. LTD.

This content was sourced from clinicaltrials.gov