A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.

• Sponsor: Astellas Pharma Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00790660
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arms: 5
• Actual Duration (Months): 4.4
• Patients Per Site Per Month: 13.9

Study Details

Study Description

Brief Summary

This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: ASP1941; Drug: Placebo	Phase 2

Detailed Description

Trial includes a two week washout period before entering the treatment period for subjects on oral anti-diabetic medication.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Multiple Dose Study to Assess the Safety and Tolerability of ASP1941 in Adult Subjects With Type 2 Diabetes Mellitus
• Actual Study Start Date: Oct 23, 2008
• Actual Primary Completion Date: Mar 6, 2009
• Actual Study Completion Date: Mar 6, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP1941 Lowest Dose Oral	Drug: ASP1941; Oral
Experimental: ASP1941 Low Dose Oral	Drug: ASP1941; Oral
Experimental: ASP1941 Medium Dose Oral	Drug: ASP1941; Oral
Experimental: ASP1941 High Dose Oral	Drug: ASP1941; Oral
Placebo Comparator: Placebo Oral	Drug: Placebo; Oral

Outcome Measures

Primary Outcome Measures

1. Evaluation of safety through clinical safety labs and adverse events [6 Weeks]

Secondary Outcome Measures

1. Evaluation of routine PK and PD parameters [6 Weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Established diagnosis of type 2 diabetes mellitus

• HbA1c value between 7.0 and 10.0%

• Body mass index between 20 and 45 kg/m2

Exclusion Criteria:

• Established diagnosis of type 1 diabetes mellitus

• Serum creatinine > upper limit of normal range

• Proteinuria (microalbumin/creatinine ratio > 300 mg/g)

• Urinary tract infection

• Severe uncontrolled Hypertension

• Significant renal, hepatic or cardiovascular disease

• HIV Positive

• History of drug or alcohol abuse/dependency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Astellas Pharma Inc

Investigators

• Study Director: use Central Contact, Astellas Pharma Global Development

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Link to results on the Astellas Clinical Study Results website.

Publications

None provided.

• Responsible Party: Astellas Pharma Inc
• ClinicalTrials.gov Identifier: NCT00790660
• Other Study ID Numbers: 1941-CL-0016
• First Posted: Nov 13, 2008
• Last Update Posted: Apr 2, 2018
• Last Verified: Mar 1, 2018

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

Study Results

No Results Posted as of Apr 2, 2018