Clinical trial NCT02317484: Investigation for Clinical Efficacy and Safety of Ipragliflozin 50mg and 100mg on Type II Diabetes
Official title: Investigation for Clinical Efficacy and Safety of Ipragliflozin 50mg and 100mg on Type II Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Osaka Saiseikai Nakatsu Hospital
name: Astellas Pharma Inc
First posted: 2014-12-16
Enrollment: 231
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic and hospital

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.


Eligibility criteria: 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

Primary outcomes:
measure: HbA1c change level
timeFrame: After 52 weeks from the time of treatment initiation
Secondary outcomes:
measure: Sugar metabolism and body composition change levels
timeFrame: After 12, 24, 36, 52 weeks from the time of the start of treatment
measure: HbA1c achievement rate
timeFrame: After 12, 24, 36, 52 weeks from the time of treatment initiation
measure: Body composition and visceral fat change levels
timeFrame: After 24 and 52 weeks from the time of treatment initiation
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka Saiseikai Nakatsu Hospital
Study officials:
affiliation: Osaka Saiseikai Nakatsu Hospital
name: Haruo Nishimura
role: PRINCIPAL_INVESTIGATOR
References: