Brief Summary

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus

Trial Health

On Track

Trial Health Score

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

Enrollment

361

participants targeted

Target at P75+ for phase_2 diabetes-mellitus

Timeline

Completed

Started Mar 2008

Shorter than P25 for phase_2 diabetes-mellitus

Geographic Reach

1 country

8 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

12 months study duration

First Submitted

Initial submission to the registry

February 13, 2008

Completed

9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed

1 month until next milestone

Study Start

First participant enrolled

March 26, 2008

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2009

Completed

Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

12 months

First QC Date

February 13, 2008

Last Update Submit

November 8, 2024

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus, Type 2ASP1941

Outcome Measures

Primary Outcomes (1)

HbA1c level
12 weeks

Secondary Outcomes (2)

Blood glucose level
12 Weeks
Safety
12 Weeks

Study Arms (5)

1

EXPERIMENTAL

Lowest dose

Drug: ipragliflozin

2

EXPERIMENTAL

Low-middle dose

Drug: ipragliflozin

3

EXPERIMENTAL

High-middle dose

Drug: ipragliflozin

4

EXPERIMENTAL

Highest dose

Drug: ipragliflozin

5

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

ipragliflozinDRUG

Oral

Also known as: ASP1941

1234

PlaceboDRUG

Oral

Eligibility Criteria

Age20 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Established diagnosis of type 2 diabetes mellitus
Fasting serum C-peptide level \> 0.6 ng/mL
HbA1c between 7.0 and 10.0%
Body Mass Index between 20 and 45 kg/m2

You may not qualify if:

Serum creatinine \> upper limit of normal
Proteinuria (albumin/creatinine ratio \> 300 mg/g)
Dysuria and/or urinary tract infection
Significant renal, hepatic or cardiovascular diseases
Ketosis
Hypertension
Severe gastrointestinal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Astellas Pharma Inclead

Study Sites (8)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaidou, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

Related Publications (2)

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.
PMID: 31606880DERIVED
Kashiwagi A, Kazuta K, Yoshida S, Nagase I. Randomized, placebo-controlled, double-blind glycemic control trial of novel sodium-dependent glucose cotransporter 2 inhibitor ipragliflozin in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2014 Jul;5(4):382-91. doi: 10.1111/jdi.12156. Epub 2013 Nov 28.
PMID: 25411597DERIVED

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

ipragliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

Central Contact
Astellas Pharma Inc
STUDY CHAIR

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

February 13, 2008

First Posted

February 22, 2008

Study Start

March 26, 2008

Primary Completion

March 14, 2009

Study Completion

March 14, 2009

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing: Will not share

Locations

JP(8)

A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (5)

1

2

3

4

5

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (8)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (5)

1

2

3

4

5

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (8)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations