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
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
1 other identifier
interventional
620
1 country
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes
Started Jul 2010
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 22, 2010
CompletedFirst Posted
Study publicly available on registry
July 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedAugust 17, 2011
August 1, 2011
1 year
July 22, 2010
August 15, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c from baseline to Week 16.
Change in HbA1c from baseline to Week 16 with last observation carried forward (LOCF).
Baseline, 16 weeks
Secondary Outcomes (1)
Change from baseline in Fasting Plasma Glucose (FPG)
Baseline, 16 weeks
Study Arms (6)
SK-0403 100 mg QD
EXPERIMENTALSK-0403 200 mg QD
EXPERIMENTALSK-0403 400 mg QD
EXPERIMENTALSK-0403 200 mg BID
EXPERIMENTALPlacebo
SHAM COMPARATORSitagliptin 100 mg QD
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Muscle Shoals, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Encinitas, California, United States
Unknown Facility
Huntington Park, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Mateo, California, United States
Unknown Facility
Spring Valley, California, United States
Unknown Facility
Walnut Creek, California, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Palm Harbour, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Honolulu, Hawaii, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Paducah, Kentucky, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Saint Paul, Minnesota, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Greenville, North Carolina, United States
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Statesville, North Carolina, United States
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Cincinnati, Ohio, United States
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Marion, Ohio, United States
Unknown Facility
Mount Giliad, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Beaver, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Greensboro, South Carolina, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
Unknown Facility
Sandy City, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 22, 2010
First Posted
July 23, 2010
Study Start
July 1, 2010
Primary Completion
July 1, 2011
Study Completion
August 1, 2011
Last Updated
August 17, 2011
Record last verified: 2011-08