NCT03076112

Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are 1) to compare the effect of ipragliflozin 50 mg on glucose-lowering effect with sitagliptin 100 mg in patients with type 2 diabetes mellitus, whose HbA1c level is ≥ 7.5% with sulfonylurea and metformin, 2) to investigate changes of other metabolic and cardiovascular risk factors such as triglyceride, HDL-cholesterol, uric acid, blood pressure, and inflammatory markers, 3) to examine changes of body composition including fat and muscle mass with volume status.

Detailed description

The objectives of this study are to compare the effect of 50mg of ipragliflozin, a SGLT2 inhibitor, on glucose-lowering effect with 100mg of sitagliptin, a DPP4 inhibitor in patients with type 2 diabetes mellitus, whose HbA1c level is ≥ 7.5% with sulfonylurea and metformin. We are also going to investigate changes of other metabolic and cardiovascular risk factors such as triglyceride, HDL-cholesterol, uric acid, blood pressure, and inflammatory markers. Changes of body composition including fat and muscle mass with volume status will be also examined.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Ipragliflozin	Ipragliflozin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes
DRUG	Sitagliptin	Sitagliptin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes

Timeline

• Start date: 2017-04-25
• Primary completion: 2022-06-30
• Completion: 2022-08-31
• First posted: 2017-03-09
• Last updated: 2022-10-04

Locations

1 site across 1 country: South Korea