A Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy

August 15, 2011 updated by: Kowa Research Institute, Inc.

A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Controlled Phase 2 Dose Finding Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy

The purpose of this study is to evaluate the safety and efficacy of a range of doses of SK-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

620

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
      • Huntsville, Alabama, United States
      • Muscle Shoals, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Encinitas, California, United States
      • Huntington Park, California, United States
      • Los Angeles, California, United States
      • San Mateo, California, United States
      • Spring Valley, California, United States
      • Walnut Creek, California, United States
    • Florida
      • Miami, Florida, United States
      • Palm Harbour, Florida, United States
      • Pembroke Pines, Florida, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Paducah, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Minnesota
      • St. Paul, Minnesota, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Greenville, North Carolina, United States
      • Statesville, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Marion, Ohio, United States
      • Mount Giliad, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Eugene, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Beaver, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Greensboro, South Carolina, United States
    • Texas
      • Corpus Christi, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
      • Sandy, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States

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:

  • Male and female subjects with type 2 diabetes between 18 and 75 years of age, inclusive
  • Screening HbA1c between 7.0% to 10.0% for metformin stable subjects, 6.5% to 9.0% for subjects on metformin and 1 other antidiabetic agent (excluding thiazolidinediones, insulin, or incretin therapies [DPP-4 inhibitors and GLP-1 analogues]), or 7.5% to 11.0% for subjects on no antidiabetic medication or, if taking metformin, not on a stable dose of 1500 mg/day or maximum tolerated dose.
  • No antidiabetic medication other than metformin for 3 months prior to randomization.
  • Fasting plasma glucose less than 270 mg/dL (15 mmol/L) at screening.
  • Body mass index between 20 kg/m2 and 45 kg/m2 inclusive at screening.

Exclusion Criteria:

  • History of type 1 diabetes.
  • Received treatment with insulin within 30 days of the screening visit or for more than 1 week within 3 months of the screening visit.
  • Use of 3 or more oral antidiabetic medications at the time of the screening visit.

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
Sham Comparator: Placebo
Drug: Placebo
Placebo
Experimental: SK-0403 100 mg QD
Drug: SK-0403
SK-0403
Experimental: SK-0403 200 mg QD
Drug: SK-0403
SK-0403
Experimental: SK-0403 400 mg QD
Drug: SK-0403
SK-0403
Experimental: SK-0403 200 mg BID
Drug: SK-0403
SK-0403
Active Comparator: Sitagliptin 100 mg QD
Drug: Sitagliptin
Sitagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c from baseline to Week 16.
Time Frame: Baseline, 16 weeks
Change in HbA1c from baseline to Week 16 with last observation carried forward (LOCF).
Baseline, 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Fasting Plasma Glucose (FPG)
Time Frame: Baseline, 16 weeks
Baseline, 16 weeks

Collaborators and Investigators

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

Sponsor

Kowa Research Institute, 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

July 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 22, 2010

First Submitted That Met QC Criteria

July 22, 2010

First Posted (Estimate)

July 23, 2010

Study Record Updates

Last Update Posted (Estimate)

August 17, 2011

Last Update Submitted That Met QC Criteria

August 15, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SK-0403-2.01US

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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