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

This study has been completed.
Sponsor:
Information provided by:
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01169090
First received: July 22, 2010
Last updated: August 15, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: SK-0403
Drug: Placebo
Drug: Sitagliptin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Kowa Research Institute, Inc.:

Primary Outcome Measures:
  • Change in HbA1c from baseline to Week 16. [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline to Week 16 with last observation carried forward (LOCF).


Secondary Outcome Measures:
  • Change from baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 620
Study Start Date: July 2010
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SK-0403 100 mg QD Drug: SK-0403
SK-0403
Experimental: SK-0403 200 mg QD Drug: SK-0403
SK-0403
Experimental: SK-0403 400 mg QD Drug: SK-0403
SK-0403
Experimental: SK-0403 200 mg BID Drug: SK-0403
SK-0403
Sham Comparator: Placebo Drug: Placebo
Placebo
Active Comparator: Sitagliptin 100 mg QD Drug: Sitagliptin
Sitagliptin

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169090

  Show 40 Study Locations
Sponsors and Collaborators
Kowa Research Institute, Inc.
  More Information

No publications provided

Responsible Party: Roger Morgan, MD Chief Medical Officer, Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01169090     History of Changes
Other Study ID Numbers: SK-0403-2.01US
Study First Received: July 22, 2010
Last Updated: August 15, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 14, 2014