Comparison of the effects of insulin monotherapy and combination therapy with ipragliflozin and insulin on glucose toxicity in type 2 diabetes mellitus : a randomized controlled trial

Not Applicable

• Conditions: Type 2 diabetes

• Registration Number: JPRN-UMIN000018784
• Lead Sponsor: Osaka university medical hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-01
• Study Completion: 2018-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients less than 20 years old or 75 years or older, and without consent 2) BMI<20kg/m2 3) Patients with severe diabetic complication (pre-proliferative retinopathy/proliferative retinopathy, eGFR<45ml/min/1.73m2, cardiovascular/cerebrovascular disease) 4) Patiens severe liver dysfunction (AST or ALT 100 IU/L or more, or T-Bil 2.0 mg/dl or more) 5) Patients who have malignant neoplasm 6) Patients taking glucocorticoid medicine 7) Patines with malnutrition or dehydration 8) Patients who correspond to the administration contraindication of ipragliflozin or insulin 9) Woman who are pregnant, nursing or possibly pregnant 10) Patients who considered not eligible for the study by the attending doctor due to other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Period to achieve target blood glucose levels

Secondary Outcome Measures

Name	Time	Method
1. Changes in parameters of glucose metabolism Total daily insulin dose, daily profile of blood glucose, plasma glucose, serum insulin and C-peptide and plasma glucagon levels during mixed-meal tolerance test 2. Changes in body weight and parameters of body fluid volume Body weight, waist circumstance, serum ketone body fraction, Hematocrit, serum ureanitrogen, uric acid and BNP, urinary ketone body 3. Changes in parameters of lipid metabolism Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride 4. Changes in parameters of renal function Serum creatinine, urinary albumin and beta 2 microglobulin 5. Changes in parameters of bone metabolism Serum Ca, P, Mg, PTH, 25(OH)VD, BAP, TRACP-5b, FGF23, urinary Ca, urinary P, urinary Mg 6. Incidence rate and severity of adverse events