A Study to Assess Safety and Efficacy of ASP1941 in Combination With Nateglinide in Type 2 Diabetic Patients

NCT ID: NCT01316107

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-15

Study Completion Date

2012-10-19

Brief Summary

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This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and Nateglinide inhibitor in Japanese patients with type 2 diabetes mellitus.

Detailed Description

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This is a 52-week multi-center, open-label, non-comparative study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on Nateglinide alone more than 4 weeks. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASP group

Concomitant administration of ASP1941 and nateglinide

Group Type EXPERIMENTAL

ipragliflozin

Intervention Type DRUG

oral

nateglinide

Intervention Type DRUG

oral

Interventions

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ipragliflozin

oral

Intervention Type DRUG

nateglinide

oral

Intervention Type DRUG

Other Intervention Names

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ASP1941 Starsis Fastic

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetic patients receiving with Nateglinide mono-therapy for at least 4 weeks
* HbA1c value between 6.5 and 9.5%
* Body Mass Index (BMI) 20.0 - 45.0 kg/m2

Exclusion Criteria

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300mg/g)
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Hokkaido, , Japan

Site Status

Kantou, , Japan

Site Status

Kyushu, , Japan

Site Status

Tōhoku, , Japan

Site Status

Countries

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Japan

Related Links

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https://www.astellasclinicalstudyresults.com/study.aspx?ID=105

Link to results on Astellas Clinical Study Results website

Other Identifiers

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1941-CL-0111

Identifier Type: -

Identifier Source: org_study_id

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