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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00621868
First received: February 13, 2008
Last updated: April 7, 2009
Last verified: April 2009
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: 1
Lowest dose
 Drug: ASP1941
Oral
Experimental: 2
Low-middle dose
 Drug: ASP1941
Oral
Experimental: 3
High-middle dose
 Drug: ASP1941
Oral
Experimental: 4
Highest dose
 Drug: ASP1941
Oral
Placebo Comparator: 5 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
Chubu, Japan
Chugoku, Japan
Hokkaidou, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Shikoku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc
  More Information

No publications provided

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

Keywords provided by Astellas Pharma Inc:
Diabetes Mellitus, Type 2
ASP1941

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013