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

Phase 4

• Conditions: D003924; Diabetes Mellitus, Type 2

• Registration Number: JPRN-jRCTs011180024
• Lead Sponsor: Watanabe Taku

Brief Summary

Regarding glycemic control, improvement was observed in both the ipragliflozin combination group and the metformin double dose group, but no significant difference was observed between the two groups. However, with regard to the antiobesity effect and favorable changes in metabolic parameters, it was suggested that the combination of ipragliflozin may be more effective than increasing the amount of metformin.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-25
• Study Completion: 2019-08-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 140

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The amount of change in HbA1c before and after the study

Secondary Outcome Measures

Name	Time	Method
safety and body weight, blood pressure, changes in various blood / urine tests