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

NCT02317484 | Completed

• 1 other identifier: TRIEND1413
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c change level

  After 52 weeks from the time of treatment initiation

Secondary Outcomes (3)

• Sugar metabolism and body composition change levels

  After 12, 24, 36, 52 weeks from the time of the start of treatment

• HbA1c achievement rate

  After 12, 24, 36, 52 weeks from the time of treatment initiation

• Body composition and visceral fat change levels

  After 24 and 52 weeks from the time of treatment initiation

Study Arms (1)

Ipragliflozin (SGLT2 inhibitor)

Drug: Ipragliflozin (SGLT2 inhibitor)

Interventions

Ipragliflozin (SGLT2 inhibitor) DRUG

Ipragliflozin (SGLT2 inhibitor)

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic and hospital

You may qualify if:

• Diabetes Mellitus, Type 2 patients poorly-controlled by diet and exercise therapies or additional treatment with various diabetic drugs
• Patients with changes within +- 0.5% of HbA1c
• Patients with the variation of 6.5% =\< HbA1C =\<10%
• Patients with written informed consents
• Patients whose BMI is =\>20kg/m2

You may not qualify if:

• Patients with Diabetes Mellitus, Type 1, other types of diabetes or pregnancy diabetes
• Patients with history of severe ketoacidosis, diabetic coma or profound coma for the last 6 months
• Patients with severe infection, in the perioperative period or severe trauma
• 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)
• Patients with severe hepatic impairment (judged by the attending doctor)
• Patients with history of requirement of hospitalization for severe cardiovascular event for the last 6 months of consent
• Patients in pregnancy, breast-feeding, with childbearing potential or plan of pregnancy
• Patients with neuropathic bladder or dysuria
• Patients under treatment with diuretic
• Patients under SGLT2 treatment at the kickoff point of the study
• Patients with a history of hypersensitivity to SGLT2 inhibitors
• Patients who are judged ineligible by the principal investigator

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• Osaka Saiseikai Nakatsu Hospital: collaborator
• Astellas Pharma Inc: collaborator

Study Sites (1)

Osaka Saiseikai Nakatsu Hospital

Osaka, 530-0012, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ipragliflozin; Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Haruo Nishimura

  Osaka Saiseikai Nakatsu Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 16, 2014
• Study Start: November 1, 2014
• Primary Completion: November 21, 2017
• Study Completion: February 28, 2018
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

JP (1)