Correlation Between Change of HbA1c, Urinary Glucose Excretion and Other Factors in Patients Treated With Ipragliflozin

NCT02791035 | Completed Phase 4

• 1 other identifier: AMC 2016-0100
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the correlation between change of HbA1c, urinary glucose excretion and other factors when ipragliflozin is added to preexisting therapy in subjects with type 2 diabetes.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Correlation between change of HbA1c and urinary glucose excretion

  Baseline and week 12

Secondary Outcomes (6)

• Correlation between reduction in HbA1c and various parameters (HOMA-IR, HOMA-ß, insulinogenic index)

  Baseline and week 12

• Correlation between increase in urinary glucose excretion and various parameters (HOMA-IR, HOMA-ß, insulinogenic index)

  Baseline and week 12

• Change of HbA1c

  Baseline and week 12

• Chang e of fasting glucose

  Baseline and week 12

• Change of waist circumference

  Baseline and week 12

Study Arms (1)

Ipragliflozin

EXPERIMENTAL

Ipragliflozin 50 mg/tablet, orally, 1 tablet once daily for 12 weeks

Drug: Oral administration of Ipragliflozin

Interventions

Oral administration of Ipragliflozin DRUG

Ipragliflozin

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject who has written informed consent
• Subjects who are diagnosed as type 2 diabetes mellitus
• Subjects who are 20 to 70 years old
• Subjects on a stable diet and exercise at least 8 weeks prior to the study participation
• Stable doses of the following medications for 8 weeks or more but, HbA1c level of 7.0 to 9.5% (Metformin, Metformin + SU, Metformin + DPP-4 inhibitor, Metformin + TZD, TZD, TZD + SU, TZD + DPP-4 inhibitor, SU, SU + DPP-4 inhibitor, DPP-4 inhibitor)

You may not qualify if:

• Type 1 DM
• Gestational DM
• Diabetic ketoacidosis
• CKD stage 3B-5 (eGFR 45)
• Severe infection, serious trauma, or perioperative period
• Known or suspected hypersensitivity to ipragliflozin
• Symptomatic urogenital infection
• Chemotherapy or radiation therapy for malignant tumor or diagnosis of malignant tumor within 5 years (except for thyroid cancer)
• Under the therapeutic intervention and/or another clinical study using IP drug
• Hepatic disease ( 3 times of upper normal limit of AST or ALT)
• Serious voiding difficulty due to neurogenic bladder or prostate hyperplasia
• Drugs not allowed for concomitant use
• Alpha glucosidase inhibitor or meglitinide within 60 days prior to screening
• Insulin within 60 days prior to screening
• Systemic steroid use (PO, IV or IM) over 2 weeks within 3 months prior to screening

Sponsors & Collaborators

• Asan Medical Center: lead
• Severance Hospital: collaborator
• Samsung Medical Center: collaborator
• Kyung Hee University Hospital at Gangdong: collaborator
• Astellas Pharma Korea, Inc.: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 6, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 5, 2017

Record last verified: 2017-07

Locations

KR (1)