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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014