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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT01169090

Public ClinicalTrials.gov record NCT01169090. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 11, 2026, 7:12 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01169090
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Kowa Research Institute, Inc.
Industry
Enrollment
620 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2010 (Type not available)
Primary completion
Jul 2011 (Actual)
Completion
Aug 2011 (Actual)
Last update posted
Aug 17, 2011

2010 – 2011

United States locations

U.S. sites
40
U.S. states
19
U.S. cities
40
Facility City State ZIP Site status
Not listed Birmingham Alabama — —
Not listed Huntsville Alabama — —
Not listed Muscle Shoals Alabama — —
Not listed Phoenix Arizona — —
Not listed Encinitas California — —
Not listed Huntington Park California — —
Not listed Los Angeles California — —
Not listed San Mateo California — —
Not listed Spring Valley California — —
Not listed Walnut Creek California — —
Not listed Miami Florida — —
Not listed Palm Harbour Florida — —
Not listed Pembroke Pines Florida — —
Not listed Honolulu Hawaii — —
Not listed Chicago Illinois — —
Not listed Indianapolis Indiana — —
Not listed Lexington Kentucky — —
Not listed Paducah Kentucky — —
Not listed New Orleans Louisiana — —
Not listed Saint Paul Minnesota — —
Not listed Charlotte North Carolina — —
Not listed Greenville North Carolina — —
Not listed Statesville North Carolina — —
Not listed Cincinnati Ohio — —
Not listed Marion Ohio — —
Not listed Mount Giliad Ohio — —
Not listed Oklahoma City Oklahoma — —
Not listed Eugene Oregon — —
Not listed Portland Oregon — —
Not listed Beaver Pennsylvania — —
Not listed Charleston South Carolina — —
Not listed Greensboro South Carolina — —
Not listed Corpus Christi Texas — —
Not listed Dallas Texas — —
Not listed Houston Texas — —
Not listed San Antonio Texas — —
Not listed Salt Lake City Utah — —
Not listed Sandy City Utah — —
Not listed Norfolk Virginia — —
Not listed Richmond Virginia — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01169090, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 17, 2011 · Synced Nov 11, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01169090 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →