SUMS-ADDIT-2

Phase 4

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: JPRN-jRCTs051180018
• Lead Sponsor: Morino Katsutaro

Brief Summary

Twenty-four weeks of dapagliflozin add-on treatment effectively reduces body mass, mainly by reducing fat mass, in inadequately controlled patients with type 2 diabetes who are treated with oral anti-diabetic agents. Whole-body muscle mass is maintained, but IHTG content is reduced by dapagliflozin treatment. Although there was a small difference in the change of plasma serine concentrations between the two groups in this study, most amino acids showed subtle changes after treatment of dapagliflozin for 24

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-01-20
• Study Start: 2018-12-28
• Results First Posted: 2022-02-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Ambulatory type 2 diabetes mellitus patients on oral therapy who are obese and have not achieved target blood glucose levels.
Patients who satisfy all of the following criteria:
1)Over 20 and less than 75 years of age at the time of informed consent acquisition
2)Type 2 diabetes mellitus patient on oral therapy
3)Patients whose HbA1c is more than 7.0% and less than 10.0%
4)Patients whose BMI is more than 23 kg/m2
5)Patients whose eGFR more than 45 ml/min/1.73 m2
6)Patients who are ambulatory
7)Patients who received explanation of the research using an informed consent form and gave written consent on research participation

Exclusion Criteria

1)Patients who have taken SGLT2 inhibitors
2)Patients treated with insulin, GLP-1 receptor agonists
3)Patients with severe ketosis, diabetic coma or precoma
4)Patients corresponding to the contraindication of dapagliflozin (hypersensitivity, pregnant women etc.)
5)Patients with a history of hospitalization within six months for trauma, surgery and infectious diseases
6)Patients with past history of cerebral infarction, transient ischemic attack
7)Patients with past history of unstable angina, myocardial infarction within six months
8)Patients treated with loop diuretics
9)Patients with orthostatic hypotension
10)Patients deemed inappropriate to participate in the research by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified