RISING-STAR study

Not Applicable

• Conditions: type 1 diabetes mellitus

• Registration Number: JPRN-jRCTs051190114
• Lead Sponsor: Yamazaki Masahiro

Brief Summary

This study showed that the instruction to decrease the basal insulin upon the administration of SGLT2i to the patients with T1DM did not change the frequency of hypoglycemia, compared with no instruction to decrease the basal insulin. No severe hypoglycemia was reported in both groups. Time of hyperglycemia significantly decreased in both groups, Time in Range significantly increased in both groups, and HbA1c significantly decreased in both groups, suggesting usefulness of SGLT2i in patients with T1DM.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-02
• Study Completion: 2020-12-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients who meet all of the following criteria are included in this study:
1. Outpatients in the research institutions in this study who are diagnosed as type 1 diabetes mellitus before 6 months or more of giving their consent
2. Patients who have conducted the intensive insulin therapy for 1 year or longer
3. Patients who are well educated in carbohydrate counting, and who can conduct insulin self-titration
4. Patients with good understanding of the disease and capability to recognize DKA (symptoms and use of ketone meter)
5. Male and female aged 20 years or older and younger than 80 years when giving their consent
6. Patients who provide their consent in a written form

Exclusion Criteria

Patients who fall into any of the following criteria are excluded from participating in the study. The clinical laboratory values which are the latest and obtained within 3 months before obtaining their consent are used to judge the exclusion criteria:
1. Patients who use SGLT2 inhibitor at giving their content
2. Patients whose eGFR is less than 45 ml/min/1.73m2
3. Patients whose activities of daily living (ADL) is PS2 or higher
4. Patients with dementia or cognitive impairment
5. Patients whose BMI is less than 18.5 kg/m2
6. Patients with history of ketoacidosis within 3 months before giving their consent
7. Patients with history of Cardiovascular disease (myocardial infarction, heart failure, angina pectoris) within 3 months before giving their consent
8. Patients whose HbA1c is 10.5% or higher
9. Patients who had hypoglycemia 14 times or more within 4 weeks before giving their consent
10. Patients with anemia (male: Hb is 13 g/dL or less, female: Hb is 12 g/dL or less), hypoalbuminemia (serum albumin is 3.5 g/dL or less), or nephrotic syndrome (urinary protein is 3.5 g/day or more, and serum albumin is 3.0 g/dL or less) caused by primary diseases other than diabetic nephropathy
11. Patients who are breastfeeding, pregnant, possibly pregnant, or planning to be pregnant
12. Patients with cancer. However, those who have completed treatment and/or show no redevelopment of cancer, as well as manifest some degree of remission can be considered to be participants of this study
13. Patients who meet the contraindication of the study agent
14. Patients who are conducting diet therapy with carbohydrate of less than 40%
15. Patients with poor adherence judged by the attending physician
16. Patients with other conditions that the responsible investigator/subinvestigator thinks inappropriate to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of hypoglycemia per day confirmed by self-monitoring of blood glucose (SMBG) during intervention period (administration of SGLT2 inhibitor) (number of hypoglycemia/day)