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Study of Ipragliflozin in Patients With Type 2 Diabetes Mellitus Receiving Insulin Therapy

NCT02847091 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2024-11-12

No results posted yet for this study

Summary

The objective of this study is to assess the reduction in insulin dose from baseline at Week 24 while keeping the blood glucose levels controlled (maintaining HbA1c values) when ipragliflozin is administered once daily for 24 weeks in patients with type 2 diabetes mellitus receiving insulin therapy.

Conditions

Interventions

DRUG

Ipragliflozin

Oral administration, 50mg once daily

DRUG

Insulin

Patients are receiving insulin therapy from at least 12 weeks before Visit 1 (is allowed ±10% dose modification if clinically needed, and is reduced within a 20% to 40% range at Visit 1 and then is controlled up to Visit 8 based on criteria of this study).

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-29
Primary Completion
2017-11-09
Completion
2017-11-09

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02847091 on ClinicalTrials.gov