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NCT01316107 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

Official title:
Phase III Study of ASP1941 - Open-label, Non-comparative Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Combination With Nateglinide in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With Nateglinide Alone

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01316107
Other study ID # 1941-CL-0111
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 15, 2011
Est. completion date October 19, 2012

Study information
Verified date April 2019
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility
Status Completed
Enrollment 122
Est. completion date October 19, 2012
Est. primary completion date October 19, 2012
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ipragliflozin
oral
• nateglinide
oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary change from baseline in hemoglobin A1c (HbA1c) baseline and for 24 weeks
Secondary change from baseline in fasting plasma glucose baseline and for 24 weeks
Secondary change from baseline in fasting serum insulin baseline and for 24 weeks
Secondary Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) for 52 weeks
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