Pharmacodynamics, Pharmacokinetics, and Safety of ASP1941 in Patients With Type 1 Diabetes Mellitus

NCT02529449 | Completed Phase 2

• 1 other identifier: 1941-CL-6001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 11

Brief Summary

The objective of this study is to assess pharmacodynamics, pharmacokinetics, and safety of ASP1941 in patients with type 1 diabetes mellitus when administered once daily (q.d.) for 2 weeks.

Conditions

Type 1 Diabetes Mellitus

Keywords

ASP1941; type 1 diabetes mellitus; SGLT2 inhibitor

Outcome Measures

Primary Outcomes (30)

• Daily profile of plasma glucose levels

  up to Day 14

• Area under the concentration-time curve (AUC) 0-24hr (AUC0-24h) of plasma glucose levels

  at Day -1, Day 1 and Day 14

• AUC0-3h of plasma glucose levels

  at Day -1, Day 1 and Day 14

• AUC0-4h of plasma glucose levels

  up to Day 14

• AUC0-10h of plasma glucose levels

  up to Day 14

• Fasting plasma glucose levels

  up to Day 21

• Glycoalbumin

  up to Day 21

• Urinary glucose excretion

  up to Day 14

• Urinary glucose excretion rate

  up to Day 14

• Urine volume

  up to Day 14

• Urinary glucose concentration

  up to Day 15

• Body weight

  up to Day 21

• Renal glucose clearance

  up to Day 14

• Plasma concentration of unchanged ASP1941

  up to Day 14

• Urinary concentration of unchanged ASP1941

  up to Day 14

• Pharmacokinetics (PK) parameter of ASP1941 in plasma: AUC from time 0 extrapolated to infinity (AUCinf)

  at Day 1

• PK parameter of ASP1941 in plasma: AUC from the time of dosing to the last measurable concentration (AUClast)

  at Day 1 and Day 14

• PK parameter of ASP1941 in plasma: AUC from the time of dosing to 24 hr (AUC0-24h)

  at Day 1 and Day 14

• PK parameter of ASP1941 in plasma: Oral Clearance (CL/F)

  at Day 1 and Day 14

• PK parameter of ASP1941 in plasma: Maximum concentration (Cmax)

  at Day 1 and Day 14

• PK parameter of ASP1941 in plasma: Terminal Elimination Half-life (t1/2)

  at Day 1 and Day 14

• PK parameter of ASP1941 in plasma: Time of the Maximum Concentration (tmax)

  at Day 1 and Day 14

• PK parameter of ASP1941 in urine: Amount excreted in urine between time (Ae)

  at Day 1 and Day 14

• PK parameter of ASP1941 in urine: % of the dose of excreted in urine (Ae%)

  at Day 1 and Day 14

• PK parameter of ASP1941 in plasma and urine: Renal Clearance (CLr)

  at Day 1 and Day 14

• Safety assessed by vital signs

  Supine blood pressure and supine pulse rate

  up to Day 21

• Safety assessed by 12-lead electrocardiogram

  up to Day 21

• Safety assessed by laboratory tests

  Hematology, biochemistry and urinalysis

  up to Day 21

• Safety assessed by self-monitored blood glucose levels

  up to Day 21

• Safety assessed by Adverse events

  up to Day 21

Study Arms (4)

Placebo

PLACEBO COMPARATOR

once daily

Drug: Placebo

ASP1941 Low dose group

EXPERIMENTAL

once daily

Drug: ASP1941

ASP1941 Middle dose group

EXPERIMENTAL

once daily

Drug: ASP1941

ASP1941 High dose group

EXPERIMENTAL

once daily

Drug: ASP1941

Interventions

Placebo DRUG

Oral

Placebo

ASP1941 DRUG

Oral

Also known as: Suglat, Ipragliflozin

ASP1941 High dose group; ASP1941 Low dose group; ASP1941 Middle dose group

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At the time of obtaining informed consent:
• Subject is diagnosed with type 1 diabetes mellitus and has been treated with insulin therapy for at least 52 weeks (364 days).
• Subject is able to be admitted to the site as scheduled.
• Subject is able to record in Patient's diary from the first study drug dose in observation period until the day before the end of post observation.
• At screening period:
• Subject has an HbA1c (NGSP) value of between 7.5% and 10.0%. If subject has an HbA1c value of between 7.3% and 10.2% (out of the reference range), HbA1c may be re-measured only once within the allowance range in screening period. Re-measured HbA1c (NGSP) value will be adopted for the determination.
• Subject has been receiving insulin therapy at daily doses (instructed by a doctor) within a ±20% range for at least 12weeks (83days) prior to the start of screening.
• Subject has a fasting serum C-peptide level ≤0.5 ng/mL at screening.
• Subject receives treatments for complications (except for transient diseases such as a cold) that, in the investigator's or sub-investigator's opinion, need not to be changed during the period from the start of screening to the end of the treatment period.
• Subject has body mass index (BMI) value of 20.0 to 35.0 kg/m2 at screening.

You may not qualify if:

• At the time of obtaining informed consent:
• Subject has type 2 diabetes mellitus.
• Subject has participated or has been participating in a clinical study or a post marketing study of another drug or medical equipment within 12 weeks (84 days) prior to obtaining informed consent.
• Subject has received ASP1941 (ipragliflozin) with the exception of placebo.
• At screening period:
• Subject has proliferative retinopathy (subjects with stable condition after photocoagulation etc. may be enrolled in the study).
• Subject has developed hypoglycemia unawareness (requires help of a third person) or severe hypoglycemia (diabetic coma, precoma, or convulsion) within 12 weeks (84 days) prior to the start of screening.
• Subject has developed diabetic ketoacidosis within 12 weeks (84 days) prior to the start of screening.
• Subject has chronic disease(s) which require the continuous use of corticosteroids or immunosuppressants (oral administration, injection, inhalation, or suppository).
• Subject has received hypoglycemic agent(s) other than insulin within 12 weeks (83 days) prior to the start of screening.
• Subject with perioperative, severe infection or serious injury.
• Subject whose serum creatinine value exceeds the upper limit of normal range at screening.
• Subject has a urinary albumin/urinary creatinine ratio\>300 mg/g in urinalysis at screening.
• Subject has a history of clinically significant renal disease(s) such as renovascular occlusive disease, nephrectomy, and/or renal transplant.
• Subject has AST and ALT \>2 ×ULN or T-Bil \>1.5 × ULN at screening, or has a history of serious hepatic diseases.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (11)

Site JP00006

Aichi, Japan

Location

Site JP00002

Fukuoka, Japan

Location

Site JP00009

Gunma, Japan

Location

Site JP00001

Ibaraki, Japan

Location

Site JP00005

Kanagawa, Japan

Location

Site JP00008

Kanagawa, Japan

Location

Site JP00003

Okayama, Japan

Location

Site JP00004

Osaka, Japan

Location

Site JP00010

Osaka, Japan

Location

Site JP00011

Osaka, Japan

Location

Site JP00007

Tokyo, Japan

Location

Related Publications (1)

• Toyoshima J, Saito M, Kaibara A, Isaka H, Sakatani T. Comparison of the Pharmacokinetic and Pharmacodynamic Relationship of Ipragliflozin Between Patients With Type 1 and Type 2 Diabetes Mellitus. Clin Ther. 2020 Sep;42(9):1787-1798.e3. doi: 10.1016/j.clinthera.2020.07.009. Epub 2020 Aug 21.

  PMID: 32839028 DERIVED

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

ipragliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 20, 2015
• Study Start: September 1, 2015
• Primary Completion: March 19, 2016
• Study Completion: March 19, 2016
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (11)