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

Kowa

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Sitagliptin; Drug: Placebo; Drug: SK-0403

Study type: Interventional

Funder types: Industry

Identifiers

NCT01169090

SK-0403-2.01US

Details and patient eligibility

About

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.

Enrollment: 620 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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620 participants in 6 patient groups

SK-0403 100 mg QD

Experimental group

Treatment:

Drug: SK-0403

SK-0403 200 mg QD

Experimental group

Treatment:

Drug: SK-0403

SK-0403 400 mg QD

Experimental group

Treatment:

Drug: SK-0403

SK-0403 200 mg BID

Experimental group

Treatment:

Drug: SK-0403

Placebo

Sham Comparator group

Treatment:

Drug: Placebo

Sitagliptin 100 mg QD

Active Comparator group

Treatment:

Drug: Sitagliptin