JRCT ID: jRCTs051180018
Registered date:28/12/2018
SUMS-ADDIT-2
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Type 2 Diabetes Mellitus |
Date of first enrollment | 28/03/2016 |
Target sample size | 52 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | *Dapagliflozin group Drug used: Dapagliflozin 5 mg Administration: oral; once a day after breakfast Decrease SU dosage at the start of administration according to treatment guidelines. The study physician can change antidiabetic drug to be administered according to treatment guidelines so that HbA1c less than 7.0%can be reached without causing hypoglycemia. *Non-administered group Drug used: Antidiabetic drugs except insulin or GLP-1 receptor agonists Antidiabetic drugs can be changed to reach HbA1c less than 7.0% without causing hypoglycemia according to treatment guidelines. |
Outcome(s)
Primary Outcome | Difference in the changes in body weight from start of treatment to week 24 between the two groups |
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Secondary Outcome | Differences in the change from baseline to 24 weeks between the two groups among body composition, fatty liver, dietary preference, oxidative stress, metabolome, gene expression of PBMC, and symptoms of dehydration. |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | < 75age old |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | Morino Katsutaro |
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Secondary Sponsor | |
Source(s) of Monetary Support | AstraZeneca K.K.,ONO PHARMACEUTICAL CO., LTD |
Secondary ID(s) | UMIN000020239 |
Contact
Public contact | |
Name | Katsutaro Morino |
Address | Seta Tsukinowa-cho, Otsu, Shiga, JAPAN Shiga Japan 520-2192 |
Telephone | +81-77-548-2641 |
morino@belle.shiga-med.ac.jp | |
Affiliation | Shiga University of Medical Science |
Scientific contact | |
Name | Katsutaro Morino |
Address | Seta Tsukinowa-cho, Otsu, Shiga, JAPAN Shiga Japan 520-2192 |
Telephone | +81-77-548-2641 |
morino@belle.shiga-med.ac.jp | |
Affiliation | Shiga University of Medical Science |