A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.

March 29, 2018 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Trial includes a two week washout period before entering the treatment period for subjects on oral anti-diabetic medication.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Oral
Drug: Placebo
Oral
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of safety through clinical safety labs and adverse events
Time Frame: 6 Weeks
6 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of routine PK and PD parameters
Time Frame: 6 Weeks
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2008

Primary Completion (Actual)

March 6, 2009

Study Completion (Actual)

March 6, 2009

Study Registration Dates

First Submitted

November 11, 2008

First Submitted That Met QC Criteria

November 11, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Actual)

April 2, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1941-CL-0016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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