Investigation for Clinical Efficacy and Safety of Ipragliflozin 50mg and 100mg on Type II Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— HARUKAS  

Official title:

Investigation for Clinical Efficacy and Safety of Ipragliflozin 50mg and 100mg on Type II Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317484
• Other study ID #: TRIEND1413
• Status: Completed
• First received: December 11, 2014
• Last updated: April 16, 2018
• Start date: November 2014
• Est. completion date: February 28, 2018

Study information

• Verified date: April 2018
• Source: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate clinical efficacy and safety of Sodium Glucose Co-transporter 2 (SGLT2) inhibitor, ipragliflozin, at doses of 50mg and 100mg, for Type II Diabetes under usual care. It is also to investigate and analyze the exploratory influential factor of ipragliflozin treatment on clinical efficacy and safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: February 28, 2018
• Est. primary completion date: November 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

Inclusion Criteria:

1. Diabetes Mellitus, Type 2 patients poorly-controlled by diet and exercise therapies or additional treatment with various diabetic drugs

2. Patients with changes within +- 0.5% of HbA1c

3. Patients with the variation of 6.5% =< HbA1C =<10%

4. Patients with written informed consents

5. Patients whose BMI is =>20kg/m2

Exclusion Criteria:

1. Patients with Diabetes Mellitus, Type 1, other types of diabetes or pregnancy diabetes

2. Patients with history of severe ketoacidosis, diabetic coma or profound coma for the last 6 months

3. Patients with severe infection, in the perioperative period or severe trauma

4. Patients with moderate renal insufficiency (serum creatinine level: male with greater than or equal to 1.5mg/dL?female with greater than or equal to1.3mg/dL)

5. Patients with severe hepatic impairment (judged by the attending doctor)

6. Patients with history of requirement of hospitalization for severe cardiovascular event for the last 6 months of consent

7. Patients in pregnancy, breast-feeding, with childbearing potential or plan of pregnancy

8. Patients with neuropathic bladder or dysuria

9. Patients under treatment with diuretic

10. Patients under SGLT2 treatment at the kickoff point of the study

11. Patients with a history of hypersensitivity to SGLT2 inhibitors

12. Patients who are judged ineligible by the principal investigator

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Ipragliflozin (SGLT2 inhibitor)

Locations

Country	Name	City	State
Japan	Osaka Saiseikai Nakatsu Hospital	Osaka

Sponsors (3)

Lead Sponsor	Collaborator
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	Astellas Pharma Inc, Osaka Saiseikai Nakatsu Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c change level		After 52 weeks from the time of treatment initiation
Secondary	Sugar metabolism and body composition change levels	Change levels of the followings after 12, 24, 36, 52 weeks from the time of treatment initiation: HbA1c, blood glucose (both at fasting and after eating), glycoalbumin, body weight, BMI, serum lipid (TC?LDL-C?HDL-C?TG), blood pressure (both systolic and diastolic)	After 12, 24, 36, 52 weeks from the time of the start of treatment
Secondary	HbA1c achievement rate	The rate of less than HbA1c7.0% achievement after 12, 24, 36, 52 weeks from the time of treatment initiation	After 12, 24, 36, 52 weeks from the time of treatment initiation
Secondary	Body composition and visceral fat change levels	Changes of the body composition examined by DEXA (Dual-energy X-ray absorptiometry) method and visceral fat examined by CT scan after 24 and 52 weeks from the time of treatment initiation	After 24 and 52 weeks from the time of treatment initiation