Comparison of efficacy of ipraglifrozine and high-dose metformin in patients with type 2 diabetes

JRCT ID: jRCTs011180024

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetes Mellitus, Type 2
• Date of first enrollment: 24/04/2015
• Target sample size: 150
• Study type: Interventional

Intervention(s)

arm metformine:increase the dose of metformine from 750 mg/day to 1500 mg/day or from 500mg/day to 1000mg/day and observe for 52 weeks
arm ipraglyfrozine:add 50 mg of ipraglyfrozine on 750 mg/day of metformine and observe for 52 weeks

Outcome(s)

• Primary Outcome: The amount of change in HbA1c before and after the study
• Secondary Outcome: safety and body weight, blood pressure, changes in various blood / urine tests

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1. age>=20, <75
2. HbA1c>=6.5%, <10%
3. treated by 500-750 mg/day of metformine in addition to diet and exercise therapy
4. no need for additional drug for hypertension or dyslipidemia
5. written informed consent obtained

Exclude criteria

1. treated by insulin injection
2. unstable diabetic retinopathy
3. advanced liver, renal or cardiac disease(s)
4. allergy to metformine or ipraglyfrozine
5. (possible) pregnant or breast-feeding women
6. those with severe ketosis or diabetic (pre)coma
7. those with severe infection or trauma, or before/after sugery
8. those who are inappropriated for the present study

Related Information

• Primary Sponsor: Watanabe Taku
• Source(s) of Monetary Support: Astellas Pharma Inc.
• Secondary ID(s): UMIN000014963