Overview

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

Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborator:
Astellas Pharma Korea, Inc.
Treatments:
Ipragliflozin
Metformin
Sitagliptin Phosphate
Criteria
Inclusion Criteria:

- Type 2 diabetes with HbA1c 7.5% - 9.0% at screening visit

- Male or female between 20 and 75 years of age

- Patients taking sulfonylurea (glimepiride 1~8mg or gliclazide 30~120 mg or equivalent
dose) and metformin (≥ 1000 mg or maximum tolerated dose) for more than 3 months

- BMI ≥23 kg/m²

- Estimated GFR ≥ 60 ml/min/1.73m²

- Women of child bearing potential must take precautions to avoid pregnancy throughout
the study and for 4 weeks after intake of the last dose and must have a negative
urinary pregnancy test.

Exclusion Criteria:

- Type 1 diabetes, gestational diabetes, or diabetes with secondary cause

- Patients with acute coronary syndrome within 3 months prior to screening visit

- Patients with acute coronary syndrome within 3 months prior to screening visit

- Pregnant or breastfeeding women or reproductive-age women who refuse contraception

- Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT >
3-fold the upper limit of normal)

- Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer
with appropriate treatment) except thyroid cancer or carcinoma in situ

- Other clinical trials within 30 days

- Alcohol abuse

- Contraindication to SGLT2 inhibitors or Dipeptidyl-peptidase 4 inhibitors

- Taking insulin, oral hypoglycemic agents other than metformin, sulfonylurea, and the
study drugs.