NCT02847091

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

15 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 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

July 29, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2017

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

1.3 years

First QC Date

July 25, 2016

Last Update Submit

November 8, 2024

Conditions

Type 2 Diabetes Mellitus

Keywords

IpragliflozinSGLT2 inhibitorType 2 diabetes mellitusASP1941

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in insulin dose

    Baseline and Week 24

  • Percent change from baseline in insulin dose

    Baseline and Week 24

Secondary Outcomes (21)

  • Change from baseline in insulin dose

    Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and the last assessment during the treatment period (up to Week 24)

  • Percent change from baseline in insulin dose

    Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and the last assessment during the treatment period (up to Week 24)

  • Change from baseline in HbA1c

    Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)

  • Change from baseline in fasting plasma glucose

    Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)

  • Change from baseline in cholesterol

    Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)

  • +16 more secondary outcomes

Study Arms (1)

Ipragliflozin Group

EXPERIMENTAL

Ipragliflozin will be administered orally for 24 weeks.

Drug: IpragliflozinDrug: Insulin

Interventions

IpragliflozinDRUG

Oral administration, 50mg once daily

Also known as: ASP1941, Suglat
Ipragliflozin Group
InsulinDRUG

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).

Ipragliflozin Group

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject has been receiving insulin therapy for the treatment of diabetes mellitus.
  • The subject has type 2 diabetes mellitus and has been receiving insulin monotherapy or insulin therapy in combination with one or two oral hypoglycemic agents.
  • The subject has not modified diet or exercise therapies or dosage regimen of oral hypoglycemic agents, or has not switched to another pharmacotherapy for 12 weeks before Visit 1.
  • The subject has an HbA1c value between 6.5% and \<8.0%.
  • The subject has a body mass index (BMI) of \>23.0 kg/m2.
  • If the subject is a female, she must satisfy the following criteria. The subject is not of childbearing potential and satisfies any of the following criteria.
  • The subject is post-menopausal (absence of menses for at least 1 year).
  • The subject is surgically sterile.
  • The subject is of childbearing potential but satisfies all of the following criteria:
  • The subject agrees not to get pregnant to 28 days after the last dose of the study drug.
  • The subject has a negative pregnancy test. The subject agrees to use two of the established contraceptive methods listed below to 28 days after the last dose of the study drug when having heterosexual intercourse.
  • If the subject is a female, she must agree not to breastfeed to 28 days after the last dose of the study drug.
  • If the subject is a female, she must agree not to donate their eggs during the period from the assessment to 28 days after the last dose of the study drug.
  • In case a male subject's spouse or partner is of childbearing potential, the subject must agree to use two of the established contraceptive methods to 28 days after the last dose of the study drug.
  • If the subject is a male, he must agree not to donate their sperm to 28 days after the last dose of the study drug.

You may not qualify if:

  • The subject has type 1 diabetes mellitus.
  • The subject has any symptom of dysuria, anuria, oliguria or urinary retention.
  • The subject has proliferative retinopathy.
  • The subject has diabetic ketoacidosis.
  • The subject has a history or complication of medically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant.
  • The subject has a history of recurrent urinary tract infection.
  • The subject has symptomatic urinary tract infection or symptomatic genital infection.
  • The subject has chronic disease(s) that require the continuous use of corticosteroids, immunosuppressants, etc.
  • The subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, and serious heart disease within 1 year (52 weeks) before signing of the informed consent.
  • The subject has a complication or surgical history of serious gastrointestinal disorder.
  • The subject has severe hepatic dysfunction.
  • The subject has uncontrolled blood pressure.
  • The subject has unstable psychiatric disorder.
  • The subject has severe infection or serious trauma, or perioperative.
  • The subject has drug addiction or alcohol abuse.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Site JP00007

Gunma, Japan

Location

Site JP00008

Hiroshima, Japan

Location

Site JP00009

Hyōgo, Japan

Location

Site JP00010

Kanagawa, Japan

Location

Site JP00003

Mie, Japan

Location

Site JP00004

Osaka, Japan

Location

Site JP00015

Shiga, Japan

Location

Site JP00002

Tochigi, Japan

Location

Site JP00005

Tochigi, Japan

Location

Site JP00013

Tochigi, Japan

Location

Site JP00001

Tokyo, Japan

Location

Site JP00006

Tokyo, Japan

Location

Site JP00011

Tokyo, Japan

Location

Site JP00012

Tokyo, Japan

Location

Site JP00014

Tokyo, Japan

Location

Related Publications (1)

  • Ishihara H, Yamaguchi S, Sugitani T, Kosakai Y. Open-Label Study to Assess the Efficacy of Ipragliflozin for Reducing Insulin Dose in Patients with Type 2 Diabetes Mellitus Receiving Insulin Therapy. Clin Drug Investig. 2019 Dec;39(12):1213-1221. doi: 10.1007/s40261-019-00851-z.

    PMID: 31552641DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ipragliflozinInsulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Medical Director

    Astellas Pharma Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 28, 2016

Study Start

July 29, 2016

Primary Completion

November 9, 2017

Study Completion

November 9, 2017

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(15)