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Completed

NCT Number: NCT01169090

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SK-0403

Drug

SK-0403

Placebo

Drug

Placebo

Sitagliptin

Drug

Sitagliptin

Primary outcomes

  1. Change in HbA1c from baseline to Week 16.

    Time frame: Baseline, 16 weeks

    Change in HbA1c from baseline to Week 16 with last observation carried forward (LOCF).

Secondary outcomes

  1. Change from baseline in Fasting Plasma Glucose (FPG)

    Time frame: Baseline, 16 weeks

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 23, 2010
Registry last updated
Aug 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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