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A Study to Assess the Safety and Tolerability of ASP1941 in Adults 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: NCT00790660
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Brief Summary:
This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus

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

Detailed Description:
Trial includes a two week washout period before entering the treatment period for subjects on oral anti-diabetic medication.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Multiple Dose Study to Assess the Safety and Tolerability of ASP1941 in Adult Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date : October 23, 2008
Actual Primary Completion Date : March 6, 2009
Actual Study Completion Date : March 6, 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ASP1941 Lowest Dose
Oral
 Drug: ASP1941
Oral
Experimental: ASP1941 Low Dose
Oral
 Drug: ASP1941
Oral
Experimental: ASP1941 Medium Dose
Oral
 Drug: ASP1941
Oral
Experimental: ASP1941 High Dose
Oral
 Drug: ASP1941
Oral
Placebo Comparator: Placebo
Oral
 Drug: Placebo
Oral


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of safety through clinical safety labs and adverse events [ Time Frame: 6 Weeks ]

Secondary Outcome Measures :
  1. Evaluation of routine PK and PD parameters [ Time Frame: 6 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Established diagnosis of type 2 diabetes mellitus
  • HbA1c value between 7.0 and 10.0%
  • Body mass index between 20 and 45 kg/m2

Exclusion Criteria:

  • Established diagnosis of type 1 diabetes mellitus
  • Serum creatinine > upper limit of normal range
  • Proteinuria (microalbumin/creatinine ratio > 300 mg/g)
  • Urinary tract infection
  • Severe uncontrolled Hypertension
  • Significant renal, hepatic or cardiovascular disease
  • HIV Positive
  • History of drug or alcohol abuse/dependency
Contacts and Locations
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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): NCT00790660


Locations
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United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: use Central Contact Astellas Pharma Global Development
More Information
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Additional Information:

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00790660    
Other Study ID Numbers: 1941-CL-0016
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Astellas Pharma Inc:
ASP1941
Type 2 Diabetes Mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Ipragliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs