A Study to Assess the Safety and Efficacy of ASP1941 in Combination With Dipeptidyl Peptidase-4 (DPP-4) Inhibitor in Type 2 Diabetic Patients

Phase III Study of ASP1941 - Open-label, Non-comparative Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Combination With a Dipeptidyl Peptidase-4 Inhibitor in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With a Dipeptidyl Peptidase-4 Inhibitor Alone

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01242228

Enrollment

106

Registered

2010-11-16

Start date

2010-10-21

Completion date

2012-06-06

Last updated

2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Dipeptidyl peptidase-4 inhibitor, ASP1941, DPP-4 inhibitor, long-term safety, Diabetes mellitus

Brief summary

This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and DPP-4 inhibitor in Japanese patients with type 2 diabetes mellitus.

Detailed description

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 a DPP-4 inhibitor alone. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Interventions

DRUGipragliflozin

oral

DRUGDPP-4 inhibitor

oral

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 2 diabetic patients receiving with DPP-4 inhibitor 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

Design outcomes

Primary

Measure	Time frame
Change from baseline in HbA1c	baseline and 52 weeks

Secondary

Measure	Time frame
Change from baseline in fasting plasma glucose	baseline and 52 weeks
Change from baseline in fasting serum insulin	baseline and 52 weeks
Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)	for 52 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026