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

NCT ID: NCT02897219

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-29
• Study Completion Date: 2018-03-15

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).

Detailed Description

This study consists of two parts. In Part 1, ASP1941 or placebo will be administered orally in a blind manner. In Part 2, the long-term safety and efficacy of ASP1941 will be evaluated in patients who have participated in the study and completed the Part 1.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part 1 ASP1941

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

Group Type: EXPERIMENTAL

ipragliflozin

Intervention Type: DRUG

Oral administration once daily

Insulin Therapy

Intervention Type: OTHER

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

Part 1 Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral administration once daily

Insulin Therapy

Intervention Type: OTHER

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

Part 2 ASP1941

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

Group Type: EXPERIMENTAL

ipragliflozin

Intervention Type: DRUG

Oral administration once daily

Insulin Therapy

Intervention Type: OTHER

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

Interventions

ipragliflozin

Oral administration once daily

Intervention Type: DRUG

Placebo

Oral administration once daily

Intervention Type: DRUG

Insulin Therapy

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

Intervention Type: OTHER

Other Intervention Names

ASP1941

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• The subject has drug addiction or alcohol abuse.
• The subject has severe infection or serious trauma, or is perioperative.
• The subject has a history of medically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant.
• The subject has any symptoms of dysuria, anuria, oliguria, or urinary retention.
• The subject has severe renal impairment or end-stage renal failure requiring dialysis.
• The subject has an Aspartate Aminotransferase and/or Alanine Aminotransferase value that exceeds 2 times, or a total bilirubin value that exceeds 1.5 times the upper limit of the reference range.
• The subject has uncontrolled severe hypertension.
• The subject has serious gastrointestinal disease or a history of operation for serious gastrointestinal disease.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Site JP00005

Aichi, , Japan

Site JP00028

Aichi, , Japan

Site JP00003

Chiba, , Japan

Site JP00013

Chiba, , Japan

Site JP00035

Chiba, , Japan

Site JP00022

Fukuoka, , Japan

Site JP00023

Fukuoka, , Japan

Site JP00031

Fukuoka, , Japan

Site JP00002

Gunma, , Japan

Site JP00011

Gunma, , Japan

Site JP00006

Hiroshima, , Japan

Site JP00033

Hokkaido, , Japan

Site JP00034

Hokkaido, , Japan

Site JP00021

Hyōgo, , Japan

Site JP00009

Ibaraki, , Japan

Site JP00010

Ibaraki, , Japan

Site JP00004

Kanagawa, , Japan

Site JP00015

Kanagawa, , Japan

Site JP00016

Kanagawa, , Japan

Site JP00019

Mie, , Japan

Site JP00008

Nagasaki, , Japan

Site JP00024

Nagasaki, , Japan

Site JP00025

Nagasaki, , Japan

Site JP00032

Nagasaki, , Japan

Site JP00026

Niigata, , Japan

Site JP00020

Osaka, , Japan

Site JP00029

Osaka, , Japan

Site JP00036

Osaka, , Japan

Site JP00012

Saitama, , Japan

Site JP00017

Shizuoka, , Japan

Site JP00018

Shizuoka, , Japan

Site JP00001

Tochigi, , Japan

Site JP00030

Tokushima, , Japan

Site JP00014

Tokyo, , Japan

Site JP00027

Toyama, , Japan

Site JP00007

Yamaguchi, , Japan

Countries

Japan

Related Links

https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=308

Link to results on the Astellas Clinical Study Results website

Other Identifiers

1941-CL-6002

Identifier Type: -

Identifier Source: org_study_id