A Phase 2 Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus - Full Text View

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 ]

Estimated Enrollment:	310
Study Start Date:	February 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 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

Contacts

Contact: Clinical Development Administration Dep. Astellas Pharma Inc.

clinicaltrials_info@jp.astellas.com

Locations

Japan
	Recruiting
Hokkaidou, Japan
	Recruiting
Touhoku, Japan
	Recruiting
Kantou, Japan
	Recruiting
Chubu, Japan
	Recruiting
Kyushu, Japan
	Recruiting
Chugoku, Japan
	Recruiting
Shikoku, Japan
	Recruiting
Kansai, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Central Contact

Astellas Pharma Inc

More Information

Responsible Party:	Astellas Pharma Inc. ( Director )
Study ID Numbers:	1941-CL-0103
Study First Received:	February 13, 2008
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00621868
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
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009