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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01169090
• Other study ID #: SK-0403-2.01US
• Status: Completed
• Phase: Phase 2
• First received: July 22, 2010
• Last updated: August 15, 2011
• Start date: July 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• SK-0403
SK-0403
• Placebo
Placebo
• Sitagliptin
Sitagliptin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from baseline in Fasting Plasma Glucose (FPG)		Baseline, 16 weeks	No