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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT01169090

Run by

Kowa Research Institute, Inc.

People needed

620

Starts

2010-07-01

Expected to finish

2011-08-01

Last updated by the study team

2011-08-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Muscle Shoals, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Encinitas, California, United States
• Study site — Huntington Park, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Mateo, California, United States
• Study site — Spring Valley, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Miami, Florida, United States
• Study site — Palm Harbour, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Paducah, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Greenville, North Carolina, United States
• Study site — Statesville, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Marion, Ohio, United States

Full record on ClinicalTrials.gov

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