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

February 13, 2008
April 7, 2009
February 2008
March 2009   (final data collection date for primary outcome measure)
HbA1c level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00621868 on ClinicalTrials.gov Archive Site
  • Blood glucose level [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Phase 2 Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: ASP1941
    Oral
  • Drug: Placebo
    Oral
  • Experimental: 1
    Lowest dose
    Intervention: Drug: ASP1941
  • Experimental: 2
    Low-middle dose
    Intervention: Drug: ASP1941
  • Experimental: 3
    High-middle dose
    Intervention: Drug: ASP1941
  • Experimental: 4
    Highest dose
    Intervention: Drug: ASP1941
  • Placebo Comparator: 5
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
361
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00621868
1941-CL-0103
No
Director, Astellas Pharma Inc.
Astellas Pharma Inc
Not Provided
Study Chair: Central Contact Astellas Pharma Inc
Astellas Pharma Inc
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP