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NCT00698230 Clinical Trial

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

Type 2 Diabetes Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00698230
Other study ID # INCB 13739-202
Secondary ID
Status Completed
Phase Phase 2
First received June 13, 2008
Last updated February 12, 2018
Start date May 2008
Est. completion date May 2009

Study information
Verified date February 2018
Source Incyte Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 302
Est. completion date May 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• INCB013739
INCB013739 5 mg QD tablet
• INCB013739
INCB013739 15 mg QD tablet
• INCB013739
INCB013739 50 mg QD tablet
• INCB013739
INCB013739 100 mg QD tablet
• INCB013739
INCB013739 200 mg QD
• Placebo comparator matching INCB013739
Orally once daily tablet
• Metformin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline to Week 12 in hemoglobin A1c (HbA1c) Baseline and Week 12 (or early termination study visit)
Secondary Change from Baseline to Week 12 in fasting plasma glucose (FPG). Baseline and Week 12 (or early termination study visit)
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