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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00621868
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Drug: ASP1941 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 361 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : February 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Blood glucose level [ Time Frame: 12 Weeks ]
  2. Safety [ Time Frame: 12 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
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