A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment

• Sponsor: Astellas Pharma Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01097681
• Collaborator: (none)
• Enrollment: 25
• Locations: 2
• Arms: 3
• Actual Duration (Months): 4
• Patients Per Site: 12.5
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: ASP1941	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: An Open-Label Study to Assess the Effect of Different Grades of Renal Impairment in Japanese Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus Patients With Normal Renal Function
• Actual Study Start Date: Feb 16, 2010
• Actual Primary Completion Date: Jun 18, 2010
• Actual Study Completion Date: Jun 18, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal renal function group oral	Drug: ASP1941; oral
Experimental: Mild renal impairment group oral	Drug: ASP1941; oral
Experimental: Moderate renal impairment group oral	Drug: ASP1941; oral

Outcome Measures

Primary Outcome Measures

1. Plasma concentration of ASP1941 [For 72 hours after dosing]

Secondary Outcome Measures

1. Urinary levels of ASP1941 [For 72 hours after dosing]

2. Urinary glucose excretion [For 72 hours after dosing]

3. Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs [For 72 hours after dosing]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type 2 diabetic patients for at least 12 weeks

• Fasting plasma glucose level of < 240 mg/dL

• Body Mass Index ( BMI )20.0 - 35.0kg/m2

• GFR value based on the Japanese GFR estimation equation at screening, of ≥ 30 ml/min/1.73m2

Exclusion Criteria:

• Type 1 diabetes mellitus patients

• Receiving insulin within 12 weeks before screening

• Diabetic ketoacidosis

• Dysuria and/or urinary tract infection, genital infection

• Significant renal, hepatic or cardiovascular diseases

• Severe gastrointestinal diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Kansai		Japan
2		Kantou		Japan

Sponsors and Collaborators

• Astellas Pharma Inc

Investigators

• Study Chair: Use Central Contact, Astellas Pharma Inc

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Link to results on Astellas Clinical Study Results Web site

Publications

None provided.

• Responsible Party: Astellas Pharma Inc
• ClinicalTrials.gov Identifier: NCT01097681
• Other Study ID Numbers: 1941-CL-0073
• First Posted: Apr 2, 2010
• Last Update Posted: Oct 12, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Astellas Pharma Inc: Urinary glucose excretion; Diabetes mellitus; ASP1941
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Ipragliflozin

Study Results

No Results Posted as of Oct 12, 2018