A Phase 2 Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

This study has been completed.

First Received: February 13, 2008 Last Updated: April 7, 2009 History of Changes

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00621868

Purpose

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus

Condition	Intervention	Phase
Diabetes Mellitus	Drug: ASP1941 Drug: Placebo	Phase II

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

HbA1c level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood glucose level [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Safety [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment:	361
Study Start Date:	February 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lowest dose	Drug: ASP1941 Oral
2: Experimental Low-middle dose	Drug: ASP1941 Oral
3: Experimental High-middle dose	Drug: ASP1941 Oral
4: Experimental Highest dose	Drug: ASP1941 Oral
5: Placebo Comparator	Drug: Placebo Oral

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Established diagnosis of type 2 diabetes mellitus
Fasting serum C-peptide level > 0.6 ng/mL
HbA1c between 7.0 and 10.0%
Body Mass Index between 20 and 45 kg/m2

Exclusion Criteria:

Serum creatinine > upper limit of normal
Proteinuria (albumin/creatinine ratio > 300 mg/g)
Dysuria and/or urinary tract infection
Significant renal, hepatic or cardiovascular diseases
Ketosis
Hypertension
Severe gastrointestinal diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621868

Locations

Japan

Hokkaidou, Japan

Touhoku, Japan

Kantou, Japan

Chubu, Japan

Kyushu, Japan

Chugoku, Japan

Shikoku, Japan

Kansai, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Central Contact

Astellas Pharma Inc

More Information

No publications provided

Responsible Party:	Astellas Pharma Inc. ( Director )
Study ID Numbers:	1941-CL-0103
Study First Received:	February 13, 2008
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00621868 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:

Diabetes Mellitus, Type 2
ASP1941

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009