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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: February 13, 2008
Last updated: January 18, 2016
Last verified: January 2016
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • HbA1c level [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Blood glucose level [ Time Frame: 12 Weeks ]
  • Safety [ Time Frame: 12 Weeks ]

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
Experimental: 2
Low-middle dose
Drug: ASP1941
Experimental: 3
High-middle dose
Drug: ASP1941
Experimental: 4
Highest dose
Drug: ASP1941
Placebo Comparator: 5 Drug: Placebo


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00621868

Chubu, Japan
Chugoku, Japan
Hokkaidou, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Shikoku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Central Contact Astellas Pharma Inc
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc Identifier: NCT00621868     History of Changes
Other Study ID Numbers: 1941-CL-0103
Study First Received: February 13, 2008
Last Updated: January 18, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on May 25, 2017