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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: SK-0403
* Drug: Placebo
* Drug: Sitagliptin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SK-0403 100 mg QD<br> | Drug: SK-0403<br>* SK-0403<br>|
| Experimental: SK-0403 200 mg QD<br> | Drug: SK-0403<br>* SK-0403<br>|
| Experimental: SK-0403 400 mg QD<br> | Drug: SK-0403<br>* SK-0403<br>|
| Experimental: SK-0403 200 mg BID<br> | Drug: SK-0403<br>* SK-0403<br>|
| Sham Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: Sitagliptin 100 mg QD<br> | Drug: Sitagliptin<br>* Sitagliptin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Fasting Plasma Glucose (FPG) |  | Baseline, 16 weeks |