ROAD-EURASIA

Not Applicable

• Conditions: type 2 diabetes

• Registration Number: JPRN-jRCTs031180272
• Lead Sponsor: Issiki Masashi

Brief Summary

Regarding the primary outcome, i.e., the difference of the change in the PRA after 24 weeks of dapagliflozin treatment from the control group, the statistical power for this detection was too small to reach the conclusion. Among the secondary outcomes, the PAC after 24 weeks of dapagliflozin treatment did not show clinically meaningful difference from the control group in hypertensive type 2 diabetes patients on angiotensin-converting enzyme inhibitors or angiotensin receptor blockers.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-02-26
• Study Start: 2019-03-14
• Results First Posted: 2020-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

1)Type 2 diabetic patients
2)Patients with HbA1c of 6.5% to 8.4%
3)Patients whose HbA1c is within 1% during the last 3 months
4)Hypertension patients who are treated with renin-angiotensin system inhibitor (referred as RAS inhibitor) from 8 weeks before screening or earlier (concomitant use of a direct renin inhibitor, an angiotensin-converting enzyme inhibitor or an angiotensin II receptor antagonist is to be prohibited)
5)Patients with BMI of 22.0 kg/m2 or higher
6)Patients from 20 years old but less than 75 years old at obtaining consent
7)Patients with eGFRcys of 45 mL/min/1.73m2 or higher
8)Patients having no dosing history of SGLT2 inhibitor within 4 months

Exclusion Criteria

1)Type 1 diabetes,
2)Class III hypertension (SBP180 mmHg or more and/or DBP110 mmHg or more),
3)Clinical history (CH) of hypersensitivity to SGLT2 inhibitors,
4)Severe ketosis, diabetic coma or precoma,
5)Severe infectious disease, pre/post-surgery or serious trauma,
6)Severe renal dysfunction or end-stage renal failure under dialysis,
7)Pulmonary embolus or severe pulmonary function impediment,
8)Pituitary or adrenal gland dysfunction,
9)Status of dystrophy/starvation, irregular meal intake,dietary intake deficiency or hyposthenia.
10)Excessive alcohol intake.
11)CH of the following severe liver dysfunctions: AST and/or ALT100 U/L or more, total bilirubin 2.0 mg/dL (34.2 micromol/L)or more,
12)Dehydrated patients including those with non-functioning GIT such as diarrhea, vomiting or malignancy,
13) Complicated with malignancies,
14)Pregnant/ possible pregnant, breast-feeding,
15)Inappropriate patients for study participation judged by principal or clinical investigator,
16)Dosing of direct renin inhibitor,
17)Combined use of angiotensin-convertase inhibitor/ angiotensin II receptor antagonists,
18)Dosing of beta- or alpha,beta-blocking agent or its dosing history (DH) within 4 months,
19)Dosing of diuretic drugs or its DH within 2 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
plasma renin activity (PRA)

Secondary Outcome Measures

Name	Time	Method
Group comparison of the following parameters before and after treatment <br>1)Physical examination Body weight, BMI, blood pressure, and pulse rate <br>2)Electrocardiogram <br>3)Hematology <br>WBC, RBC, Hb, Ht, PLT <br>4)Biochemistry <br>TC, HDL-C, TG, Cys-C, eGFRcys, Cr, BUN, UA,Na, K, Cl, HbA1c, and fasting blood sugar <br>5)Plasma aldosterone concentration (PAC) <br>6)AVP, BNP <br>7)Urinalysis <br>Urine protein, urine sugar, specific gravity urine, urine sodium, urine potassium and urine chromium <br>8)Adverse events