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Completed

NCT Number: NCT02317484

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka Saiseikai Nakatsu Hospital

Osaka, 530-0012, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Ipragliflozin (SGLT2 inhibitor)

Drug

Primary outcomes

  1. HbA1c change level

    Time frame: After 52 weeks from the time of treatment initiation

Secondary outcomes

  1. Sugar metabolism and body composition change levels

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

    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)

  2. HbA1c achievement rate

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

    The rate of less than HbA1c7.0% achievement after 12, 24, 36, 52 weeks from the time of treatment initiation

  3. Body composition and visceral fat change levels

    Time frame: After 24 and 52 weeks from the time of treatment initiation

    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

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Astellas Pharma Inc
  • Osaka Saiseikai Nakatsu Hospital

Registry information

Acronym: HARUKAS

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Dec 16, 2014
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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