A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal Impairment

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Long-term Study of ASP1941 — Long-term Study in Patients With Type 2 Diabetes Mellitus With Decreased Renal Function (Japanese)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316094
• Other study ID #: 1941-CL-0072
• Status: Completed
• Phase: Phase 3
• Start date: January 18, 2011
• Est. completion date: November 28, 2012

Study information

• Verified date: April 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to assess the effect of renal function on the efficacy and safety of ASP1941 in type 2 diabetic patients with mild to moderate renal impairment.

Description:

This study will be conducted in patients with type 2 diabetes mellitus and mild to moderate renal impairment who have inadequate glycemic control on an exercise program and stable diet, or one oral hypoglycemic agent.

The severity of the reduction in renal function in each subject will be classified according to the glomerular filtration rate (GFR) estimated using the Japanese GFR estimation equation. Subjects will start with a screening period, followed by a single-blind placebo run-in period, and will be randomized to the ASP1941 groups or the placebo group at a ratio of 2:1. For randomization, subjects will be stratified according to the severity of the reduction in renal function. In a treatment period, subject will receive study drug or placebo for 24 weeks under double-blind conditions.

At 24 week, subjects who are willing to continue participation in the study will receive study drug for another 28 weeks in an open label condition. ASP1941 can be increased. After completion of the study drug administration, a follow-up period will be provided.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: November 28, 2012
• Est. primary completion date: November 28, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

Inclusion Criteria:

• type 2 diabetes mellitus patient

• subject has been on an exercise program and stable diet, or one oral hypoglycemic agent (alpha-glucosidase inhibitor, sulfonylurea agent and pioglitazone)

• estimated GFR value based on the Japanese GFR estimation equation of = 30 mL/min/1.73 m2 and < 90 mL/min/1.73 m2

• HbA1C value between 6.5 and 8.5%

• body mass index (BMI) 29.0 - 45.0 kg/m2

Exclusion Criteria:

• type 1 diabetes mellitus patients

• proliferative diabetic retinopathy

• subject has received insulin within 12 weeks before the study

• subject has a chronic disease which requires the continuous use of adrenocortical steroids, immunosuppressant, and loop diuretic

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• ASP1941
oral
• placebo
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	changes in Hemoglobin A1c (HbA1c)		baseline and 24 weeks
Secondary	changes in fasting plasma glucose		baseline and 24 weeks
Secondary	changes in fasting serum insulin level		baseline and 24 weeks
Secondary	changes in eGFR (estimated glomerular filtration rate)		baseline and 52 weeks
Secondary	safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs		for 52 weeks

External Links

•   Link to results on Astellas Clinical Study Results website