Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917

September 10, 2007 updated by: Daiichi Sankyo, Inc.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of CS-917 as Monotherapy for Type 2 Diabetes

This study will compare glucose lowering with CS-917 compared to placebo after 3 months of treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
      • Northport, Alabama, United States, 35476
    • Arizona
      • Mesa, Arizona, United States, 85201
      • Phoenix, Arizona, United States, 85014
      • Tempe, Arizona, United States, 85282
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
    • California
      • Cudahy, California, United States, 90201
      • Long Beach, California, United States, 90806
      • Roseville, California, United States, 95661
      • Sacramento, California, United States, 95841
      • Spring Valley, California, United States, 91978
      • Studio City, California, United States, 91604
      • Vista, California, United States, 92083
      • Walnut Creek, California, United States, 94598
      • West Hills, California, United States, 91307
    • Delaware
      • Wilmington, Delaware, United States, 19805
    • Florida
      • Brooksville, Florida, United States, 34613
      • Fort Lauderdale, Florida, United States, 33308
      • Kissimmee, Florida, United States, 34741
      • Miami, Florida, United States, 33156
      • Pembroke Pines, Florida, United States, 33028
      • Sebastian, Florida, United States
      • St. Petersburg, Florida, United States, 33709
      • Tallahassee, Florida, United States, 32308
      • West Palm Beach, Florida, United States, 33401
    • Georgia
      • Rome, Georgia, United States
      • Warner Robins, Georgia, United States, 31093
    • Kansas
      • Shawnee Mission, Kansas, United States, 66216
      • Topeka, Kansas, United States
      • Topeka, Kansas, United States, 66614
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
    • Michigan
      • Cadillac, Michigan, United States, 49601
      • Detroit, Michigan, United States, 48235
      • Interlochen, Michigan, United States, 49643
      • Livonia, Michigan, United States, 48152
    • Mississippi
      • Port Gibson, Mississippi, United States, 39150
      • Rolling Fork, Mississippi, United States, 39159
    • Missouri
      • Excelsior Springs, Missouri, United States, 64024
    • Nevada
      • Henderson, Nevada, United States, 89052
      • Las Vegas, Nevada, United States, 89103
    • New Jersey
      • Elizabeth, New Jersey, United States, 07202
      • Toms River, New Jersey, United States, 08755
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
      • Lenoir, North Carolina, United States, 28645
      • Raleigh, North Carolina, United States, 27612
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Delaware, Ohio, United States, 43015
      • Marion, Ohio, United States, 43302
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
      • Bensalem, Pennsylvania, United States, 19020
      • Pittsburgh, Pennsylvania, United States, 15206
      • Reading, Pennsylvania, United States, 19696
    • South Carolina
      • Anderson, South Carolina, United States, 29621
      • Charleston, South Carolina, United States
      • Greer, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Corpus Christi, Texas, United States, 78404
      • Houston, Texas, United States, 77024
      • Lake Jackson, Texas, United States, 77566
      • North Richland Hills, Texas, United States
      • San Antonio, Texas, United States, 78229
    • Virginia
      • Burke, Virginia, United States
    • Washington
      • Olympia, Washington, United States, 98502
    • Wisconsin
      • Madison, Wisconsin, United States, 53719

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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Drug naive or newly diagnosed type 2 diabetic subjects:
  • Never received oral antihyperglycemic or insulin therapy or
  • No oral antihyperglycemic or insulin therapy for more than 6 months since original diagnosis and
  • No insulin therapy within one year of screening, with the exception of use during hospitalization or for use in gestational diabetes and
  • No antihyperglycemic therapy for more than three consecutive days, or a total of of seven non-consecutive days, during the 8 weeks prior to screening.
  • HbA1C>6.7% and < or = to 10% at screening

Exclusion Criteria:

  • Current insulin therapy
  • Symptoms of poorly controlled diabetes
  • History of diabetic ketoacidosis or hyperosmolar, nonketonic coma within one year of screening
  • Serum bicarbonate < or = to 19 meq/L
  • Serum creatinine (Scr) > 1.4 mg/dL (females) or 1.5 mg/dL (males)
  • Contraindication to metformin

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean change from baseline in HbA1C after 12 weeks compared to placebo

Secondary Outcome Measures

Outcome Measure
Onset of efficacy of CS-917
Safety and tolerability of CS-917
Changes in other relevant glycemic and metabolic measures
Proportion of subjects achieving therapeutic response
Proportion of subjects discontinuing or requiring rescue for continued or worsening hyperglycemia

Collaborators and Investigators

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

Sponsor

Daiichi Sankyo, Inc.

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

January 1, 2006

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

February 10, 2006

First Submitted That Met QC Criteria

February 10, 2006

First Posted (Estimate)

February 13, 2006

Study Record Updates

Last Update Posted (Estimate)

September 11, 2007

Last Update Submitted That Met QC Criteria

September 10, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS0917-A-U205

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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