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A Study to Assess the Efficacy and Safety of Ipragliflozin in Combination With Insulin in Subjects With Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

ipragliflozin

placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Blood glucose, insulin, ipragliflozin, SGLT2 inhibitor

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject has been diagnosed with type 2 diabetes mellitus for at least 12 weeks (84 days) at signing of informed consent.
Subject takes constant dosage and administration of insulin preparation for more than 6 weeks (42 days)
Subject has an HbA1C value between 7.5 and 10.0% at Visit 2 and the difference of HbA1C value within ± 1.0% between Visit 1 and Visit 2
Subject has a body mass index (BMI) 20.0 - 45.0 kg/m2

Exclusion Criteria:

Subject has type 1 diabetes mellitus
Subject has proliferative diabetic retinopathy
Subject has a history of clinically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant
Subject has a history of recurrent urinary tract infection (more than three times within before 24 weeks of obtaining informed consent)
Subject has a symptomatic urinary tract infection or symptomatic genital infection
Subject has chronic disease which requires the continuous use of adrenocortical steroids and immunosuppressant (oral medication, injection, or inhalation)
Subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, and heart disease (NYHA Class III-IV) within 1 year (52 weeks) prior to Visit 1
Subject has unstable psychiatric disorder
Female subject who is currently pregnant or lactating, or who is possibly pregnant
Male and pre-menopausal female subject who cannot use an appropriate contraception during the study
Subject has severe infection, perioperative, or serious trauma
Subject has drug addiction or alcohol abuse
Subject has a history of malignant tumors (except for those who have not received treatment for malignant tumors for at least 5 years before informed consent acquisition and was not considered to have recurrence)
Subject has a history of an allergy with ipragliflozin and/or similar drugs (study drugs possessing SGLT 2 inhibitory action)
Subject has participated in another clinical study, post marketing study, or medical equipment study within 12 weeks (84 days) before providing written informed consent, or who is currently participating in any of those studies
Subject is unable, unwilling to adhere to compliances such as hospital visits and dose instruction specified in this study

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ipragliflozin group

placebo group

Arm Description

oral

Outcomes

Primary Outcome Measures

Change in HbA1C from baseline

Secondary Outcome Measures

Fasting plasma glucose

Leptin concentration

Fructosamine concentration

Adiponectin concentration

Body weight

Waist circumference

Blood glucose values of self monitoring

written in a diary

Safety assessed by the adverse events, vital signs. and laboratory tests

Full Information

NCT ID

NCT02175784

First Posted

June 25, 2014

Last Updated

April 23, 2019

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT02175784

Brief Title

A Study to Assess the Efficacy and Safety of Ipragliflozin in Combination With Insulin in Subjects With Type 2 Diabetes Mellitus

Official Title

Postmarketing Clinical Study of Ipragliflozin - Double-blind, Parallel-group Study in Combination With Insulin in Patients With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

March 31, 2014 (Actual)

Primary Completion Date

March 31, 2015 (Actual)

Study Completion Date

December 7, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess the efficacy (superiority to placebo) of ipragliflozin based on the changes in HbA1C, as well as its safety, in patients with type 2 diabetes mellitus in combination with an insulin preparation once daily for 16 weeks. The long-term (52 weeks) safety and the persistence of the efficacy will also be evaluated.

Detailed Description

This study consists of two parts. First part is a placebo-controlled multicenter, double-blind, parallel group study, in which subjects will receive ipragliflozin or placebo once daily in combination with an insulin preparation for 16 weeks. Second part is a multicenter, open-label period (36 weeks) with no placebo group. The dose of ipragliflozin can be doubled in combination with an insulin preparation during the second part.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

Blood glucose, insulin, ipragliflozin, SGLT2 inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

262 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ipragliflozin group

Arm Type

Experimental

Arm Description

oral

Arm Title

placebo group

Arm Type

Experimental

Arm Description

oral

Intervention Type

Drug

Intervention Name(s)

ipragliflozin

Other Intervention Name(s)

ASP1941, Suglat

Intervention Description

oral

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

oral

Primary Outcome Measure Information:

Title

Change in HbA1C from baseline

Time Frame

Baseline and Week 16

Secondary Outcome Measure Information:

Title

Fasting plasma glucose

Time Frame

Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Title

Leptin concentration

Time Frame

Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52

Title

Fructosamine concentration

Time Frame

Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52

Title

Adiponectin concentration

Time Frame

Baseline, Week 2, 4, 8, 12, 16, 24, 36, 52

Title

Body weight

Time Frame

Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Title

Waist circumference

Time Frame

Baseline, Week 16, 24, 52

Title

Blood glucose values of self monitoring

Description

written in a diary

Time Frame

Baseline, Week 8, 16, 24, 52

Title

Safety assessed by the adverse events, vital signs. and laboratory tests

Time Frame

Up to 52 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject has been diagnosed with type 2 diabetes mellitus for at least 12 weeks (84 days) at signing of informed consent. Subject takes constant dosage and administration of insulin preparation for more than 6 weeks (42 days) Subject has an HbA1C value between 7.5 and 10.0% at Visit 2 and the difference of HbA1C value within ± 1.0% between Visit 1 and Visit 2 Subject has a body mass index (BMI) 20.0 - 45.0 kg/m2 Exclusion Criteria: Subject has type 1 diabetes mellitus Subject has proliferative diabetic retinopathy Subject has a history of clinically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant Subject has a history of recurrent urinary tract infection (more than three times within before 24 weeks of obtaining informed consent) Subject has a symptomatic urinary tract infection or symptomatic genital infection Subject has chronic disease which requires the continuous use of adrenocortical steroids and immunosuppressant (oral medication, injection, or inhalation) Subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, and heart disease (NYHA Class III-IV) within 1 year (52 weeks) prior to Visit 1 Subject has unstable psychiatric disorder Female subject who is currently pregnant or lactating, or who is possibly pregnant Male and pre-menopausal female subject who cannot use an appropriate contraception during the study Subject has severe infection, perioperative, or serious trauma Subject has drug addiction or alcohol abuse Subject has a history of malignant tumors (except for those who have not received treatment for malignant tumors for at least 5 years before informed consent acquisition and was not considered to have recurrence) Subject has a history of an allergy with ipragliflozin and/or similar drugs (study drugs possessing SGLT 2 inhibitory action) Subject has participated in another clinical study, post marketing study, or medical equipment study within 12 weeks (84 days) before providing written informed consent, or who is currently participating in any of those studies Subject is unable, unwilling to adhere to compliances such as hospital visits and dose instruction specified in this study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Astellas Pharma Inc

Official's Role

Study Director

Facility Information:

City

Chubu

Country

Japan

City

Chugoku

Country

Japan

City

Hokkaido

Country

Japan

City

Kansai

Country

Japan

City

Kanto

Country

Japan

City

Kyushu

Country

Japan

City

Shikoku

Country

Japan

City

Touhoku

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing URL

https://www.clinicalstudydatarequest.com/

Citations:

PubMed Identifier

31606880

Citation

Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.

Results Reference

derived

PubMed Identifier

30800562

Citation

Ishihara H, Yamaguchi S, Nakao I, Asahina S, Sakatani T. Efficacy and safety of ipragliflozin as add-on therapy to insulin in Japanese patients with type 2 diabetes mellitus (IOLITE): a 36-week, open-label extension of a 16-week, randomized, placebo-controlled, double-blind study. Diabetol Int. 2018 Jul 16;10(1):37-50. doi: 10.1007/s13340-018-0359-x. eCollection 2019 Jan.

Results Reference

derived

Links:

URL

https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=171

Description

Link to results on Astellas Clinical Study Results website

Learn more about this trial

A Study to Assess the Efficacy and Safety of Ipragliflozin in Combination With Insulin in Subjects With Type 2 Diabetes Mellitus

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