A Study to Assess the Long-term Safety and Efficacy of ASP1941 in Japanese Diabetic Patients

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: NCT01054092
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The primary objective of this study is to evaluate the long-term safety of ASP1941 in patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and pharmacokinetics of ASP1941 administered before or after food intake.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: ASP1941 Phase 3

Detailed Description:
Subject will be randomized into either ASP1941 before meal or ASP1941 after meal groups. Subjects will undergo a screening period before entering the long-term treatment. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Uncontrolled, Monotherapy Study to Assess the Long-Term Safety, Tolerability and Efficacy of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
Study Start Date : December 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: before meal group
ASP1941 will be administered before meal
Drug: ASP1941
Experimental: after meal group
ASP1941 will be administered after meal
Drug: ASP1941

Primary Outcome Measures :
  1. HbA1c [ Time Frame: For 52 weeks ]

Secondary Outcome Measures :
  1. Fasting plasma glucose [ Time Frame: For 52 weeks ]
  2. Fasting serum insulin [ Time Frame: For 52 weeks ]
  3. Plasma levels of ASP1941 for population PK analysis [ Time Frame: For 52 weeks ]
  4. Safety assessed by adverse events, vital signs laboratory tests and 12-lead ECGs [ Time Frame: For 52 weeks ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Type 2 diabetic patients for at least 12 weeks
  • HbA1c value between 6.5 and 9.5%
  • Body Mass Index ( BMI )20.0 - 45.0kg/m2

Exclusion Criteria:

  • Type 1 diabetes mellitus patients
  • Serum creatinine > upper limit of normal
  • Proteinuria (albumin/creatinine ratio > 300mg/g)
  • Dysuria and/or urinary tract infection, genital infection
  • Significant renal, hepatic or cardiovascular diseases
  • Severe gastrointestinal diseases
  • Proliferative diabetic retinopathy

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): NCT01054092

Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01054092     History of Changes
Other Study ID Numbers: 1941-CL-0121
First Posted: January 22, 2010    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
Blood glucose
Food effect

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