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

Launched by SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL · Mar 6, 2017

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.