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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Ipragliflozin (SGLT2 inhibitor)

• Study Type: Observational
• Enrollment (Actual): 231

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan, 530-0012
    • Osaka Saiseikai Nakatsu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic and hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ipragliflozin (SGLT2 inhibitor)	Drug: Ipragliflozin (SGLT2 inhibitor)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c change level	After 52 weeks from the time of treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Collaborators: Astellas Pharma Inc; Osaka Saiseikai Nakatsu Hospital
• Investigators: Principal Investigator: Haruo Nishimura, Osaka Saiseikai Nakatsu Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): November 21, 2017
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimate): December 16, 2014

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Ipragliflozin
• Other Study ID Numbers: TRIEND1413