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A 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.
ClinicalTrials.gov Identifier: NCT01023945
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety, tolerability and pharmacokinetics are also evaluated.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: ASP1941 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-blind, Placebo Controlled, Monotherapy Study to Assess the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : November 7, 2009
Actual Primary Completion Date : March 26, 2010
Actual Study Completion Date : March 26, 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ASP1941 high dose group
oral
Drug: ASP1941
oral

Experimental: ASP1941 low dose group
oral
Drug: ASP1941
oral

Placebo Comparator: Placebo group
oral
Drug: Placebo
oral




Primary Outcome Measures :
  1. Change in plasma glucose levels [ Time Frame: On day 14 ]

Secondary Outcome Measures :
  1. Urinary glucose excursion [ Time Frame: On day 14 ]
  2. Pharmacokinetic parameter of ASP1941 [ Time Frame: On day 14 ]
  3. Safety by adverse events, routine safety laboratories and vital signs. [ Time Frame: During treatment ]
  4. Change in serum insulin levels [ Time Frame: On day 14 ]


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
Criteria

Inclusion Criteria:

  • Type 2 diabetic patients for at least 12 weeks
  • HbA1c value between 7.0 and 10.0% at screening
  • Fasting plasma glucose ≥ 126mg/dL and < 240mg/dL at screening
  • Body Mass Index (BMI) 20.0 - 45.0 kg/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
  • Significant renal, hepatic or cardiovascular diseases
  • 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 ClinicalTrials.gov identifier (NCT number): NCT01023945


Locations
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Japan
Kantou, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Chair: Use Central Contact Astellas Pharma Inc

Additional Information:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01023945     History of Changes
Other Study ID Numbers: 1941-CL-0070
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Keywords provided by Astellas Pharma Inc:
ASP1941
Diabetes mellitus
Blood glucose

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