CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 170 enrolled
Drug / intervention
Ipragliflozin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03076112
NCT03076112Phase 3Completed
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Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin

Seoul National University Bundang Hospital·interventional·Posted Mar 9, 2017·Updated Oct 4, 2022

In Brief

A Phase 3 clinical trial evaluating Ipragliflozin and Sitagliptin for Type 2 Diabetes Mellitus. Completed, enrolled 170 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesSouth Korea
CollaboratorsAstellas Pharma Korea, Inc.

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 9, 2017
Enrollment StartApr 25, 2017
Primary CompletionJun 30, 2022
Study CompletionAug 31, 2022
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 9.3 years ago

Interventions

Ipragliflozindrug

Ipragliflozin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes

Sitagliptindrug

Sitagliptin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes