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OpenTrials
Completed

NCT Number: NCT00698230

Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics

Determine the effect of treatment with INCB013739 administered as an 'add-on' to metformin therapy in type 2 diabetic subjects on safety and tolerability and glycemic control.

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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

Carolina, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Established diagnosis of Type 2 Diabetes
  • Stable dose of metformin for more than 8 weeks

Exclusion criteria

  • Subjects with Addison's disease or Cushing's Syndrome
  • Type 1 diabetes mellitus or secondary forms of diabetes
  • Subjects with uncontrolled thyroid disease
  • History of renal impairment

Treatment and study plan

INCB013739

Drug

INCB013739 5 mg QD tablet

Placebo comparator matching INCB013739

Drug

Orally once daily tablet

metformin

Drug

Primary outcomes

  1. Change from Baseline to Week 12 in hemoglobin A1c (HbA1c)

    Time frame: Baseline and Week 12 (or early termination study visit)

Secondary outcomes

  1. Change from Baseline to Week 12 in fasting plasma glucose (FPG).

    Time frame: Baseline and Week 12 (or early termination study visit)

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

Randomized Study to Evaluate the Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetic Subjects

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 17, 2008
Registry last updated
Feb 14, 2018

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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