NCT02897219

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

36 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 29, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

11 months

First QC Date

July 27, 2016

Last Update Submit

November 8, 2024

Conditions

Type 1 Diabetes Mellitus

Keywords

SGLT2 inhibitorASP1941type 1 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c

    Baseline and Week 24 (end of treatment period 1)

Secondary Outcomes (17)

  • Change from baseline in HbA1c

    Baseline and up to Week 56

  • Change from baseline in Fasting plasma glucose

    Baseline and up to Week 56

  • Change from baseline in self-monitored blood glucose level

    Baseline and up to Week 56

  • Change from baseline in leptin

    Baseline and up to Week 52

  • Change from baseline in glycoalbumin

    Baseline and up to Week 52

  • +12 more secondary outcomes

Study Arms (3)

Part 1 ASP1941

EXPERIMENTAL

ASP1941 will be administered for 24 weeks under double blind conditions.

Drug: ipragliflozinOther: Insulin Therapy

Part 1 Placebo

PLACEBO COMPARATOR

Placebo will be administered for 24 weeks under double blind conditions.

Drug: PlaceboOther: Insulin Therapy

Part 2 ASP1941

EXPERIMENTAL

ASP1941 will be administered for 28 weeks under open label conditions.

Drug: ipragliflozinOther: Insulin Therapy

Interventions

ipragliflozinDRUG

Oral administration once daily

Also known as: ASP1941
Part 1 ASP1941Part 2 ASP1941
PlaceboDRUG

Oral administration once daily

Part 1 Placebo
Insulin TherapyOTHER

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

Part 1 ASP1941Part 1 PlaceboPart 2 ASP1941

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject has been diagnosed with type 1 diabetes mellitus
  • The subject has been receiving insulin therapy for the treatment of diabetes mellitus.
  • The subject has not switched from an insulin product to another insulin product or switched between continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI).
  • The subject has an HbA1c value between 7.5% and 11.0% and the difference of HbA1c value is within ± 2.0%.
  • The subject has a fasting blood C-peptide level \< 0.6 ng/mL.
  • The subject has a body mass index (BMI) between 20.0 kg/m2 and 35.0 kg/m2.

You may not qualify if:

  • The subject has type 2 diabetes mellitus.
  • The subject has participated in a clinical study or post marketing study of another drug or medical equipment within 12 weeks (84 days) before providing written informed consent, or is currently participating in such a study.
  • The subject has received treatment with ASP1941 (ipragliflozin) or participated in a clinical study of ASP1941 (excluding subjects who discontinued before the investigational period).
  • The subject participated in this study previously.
  • The subject has received a hypoglycemic agent other than insulin or an α-glucosidase inhibitor.
  • The subject has proliferative retinopathy (except for those who have undergone photocoagulation etc. and whose symptoms are stable).
  • The subject has experienced severe hypoglycemia.
  • The subject has experienced diabetic ketoacidosis.
  • The subject has chronic disease that requires the continuous use of corticosteroids, immunosuppressants, etc.
  • The subject has symptomatic urinary tract infection or symptomatic genital infection.
  • The subject has a history of recurrent urinary tract infection or recurrent genital infection.
  • The subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, or another serious heart disease.
  • The subject has a concomitant malignant tumor or a history of malignant tumor
  • The subject has a history of an allergy to ASP1941 (ipragliflozin) and/or similar drugs (drugs possessing SGLT2 inhibitory action).
  • The subject has psychiatric disorder that is inappropriate for participation in the study.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

Site JP00005

Aichi, Japan

Location

Site JP00028

Aichi, Japan

Location

Site JP00003

Chiba, Japan

Location

Site JP00013

Chiba, Japan

Location

Site JP00035

Chiba, Japan

Location

Site JP00022

Fukuoka, Japan

Location

Site JP00023

Fukuoka, Japan

Location

Site JP00031

Fukuoka, Japan

Location

Site JP00002

Gunma, Japan

Location

Site JP00011

Gunma, Japan

Location

Site JP00006

Hiroshima, Japan

Location

Site JP00033

Hokkaido, Japan

Location

Site JP00034

Hokkaido, Japan

Location

Site JP00021

Hyōgo, Japan

Location

Site JP00009

Ibaraki, Japan

Location

Site JP00010

Ibaraki, Japan

Location

Site JP00004

Kanagawa, Japan

Location

Site JP00015

Kanagawa, Japan

Location

Site JP00016

Kanagawa, Japan

Location

Site JP00019

Mie, Japan

Location

Site JP00008

Nagasaki, Japan

Location

Site JP00024

Nagasaki, Japan

Location

Site JP00025

Nagasaki, Japan

Location

Site JP00032

Nagasaki, Japan

Location

Site JP00026

Niigata, Japan

Location

Site JP00020

Osaka, Japan

Location

Site JP00029

Osaka, Japan

Location

Site JP00036

Osaka, Japan

Location

Site JP00012

Saitama, Japan

Location

Site JP00017

Shizuoka, Japan

Location

Site JP00018

Shizuoka, Japan

Location

Site JP00001

Tochigi, Japan

Location

Site JP00030

Tokushima, Japan

Location

Site JP00014

Tokyo, Japan

Location

Site JP00027

Toyama, Japan

Location

Site JP00007

Yamaguchi, Japan

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

ipragliflozinConvulsive Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Psychiatric Somatic TherapiesBehavioral Disciplines and Activities

Study Officials

  • Medical Director

    Astellas Pharma Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2016

First Posted

September 13, 2016

Study Start

August 29, 2016

Primary Completion

July 22, 2017

Study Completion

March 15, 2018

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
More information

Locations

JP(36)