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

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: SK-0403; Drug: Placebo; Drug: Sitagliptin

• Registration Number: NCT01169090
• Lead Sponsor: Kowa Research Institute, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-22
• Study First Posted: 2010-07-23
• Primary Completion: 2011-07
• Status Verified: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-08-15
• Last Update Posted: 2011-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 620

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SK-0403 100 mg QD	SK-0403	-
SK-0403 200 mg QD	SK-0403	-
SK-0403 400 mg QD	SK-0403	-
SK-0403 200 mg BID	SK-0403	-
Placebo	Placebo	-
Sitagliptin 100 mg QD	Sitagliptin	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline to Week 16.	Baseline, 16 weeks	Change in HbA1c from baseline to Week 16 with last observation carried forward (LOCF).

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Fasting Plasma Glucose (FPG)	Baseline, 16 weeks