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A Study of ASP1941 in Combination With Insulin in Patients With Type 1 Diabetes Mellitus

NCT02897219 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2024-11-12

No results posted yet for this study

Summary

The objective of this study is to confirm efficacy of ASP1941 based on the changes in HbA1c and to assess its safety in subjects with type 1 diabetes mellitus receiving ASP1941 once daily in combination with insulin for 24 weeks. This study will also assess the safety/efficacy of long-term treatment (52 weeks).

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

ipragliflozin

Oral administration once daily

DRUG

Placebo

Oral administration once daily

OTHER

Insulin Therapy

Continuous subcutaneous insulin infusion or multiple daily injections as standard of care

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-29
Primary Completion
2017-07-22
Completion
2018-03-15

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

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 NCT02897219 on ClinicalTrials.gov