Clinical trial NCT00698230: Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline to Week 12 in hemoglobin A1c (HbA1c)
timeFrame: Baseline and Week 12 (or early termination study visit)
Secondary outcomes:
measure: Change from Baseline to Week 12 in fasting plasma glucose (FPG).
timeFrame: Baseline and Week 12 (or early termination study visit)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Artesia
country: United States
state: California
city: Calabasas
country: United States
state: California
city: Fresno
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Gatos
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Chiefland
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Longwood
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Dunwoody
country: United States
state: Georgia
city: Rome
country: United States
state: Georgia
city: Belleville
country: United States
state: Illinois
city: Shawnee Mission
country: United States
state: Kansas
city: Bangor
country: United States
state: Maine
city: Columbia
country: United States
state: Maryland
city: Sterling Heights
country: United States
state: Michigan
city: Florissant
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: New York
country: United States
state: New York
city: Springfield Gardens
country: United States
state: New York
city: West Seneca
country: United States
state: New York
city: Calabash
country: United States
state: North Carolina
city: Mooresville
country: United States
state: North Carolina
city: New Bern
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Kettering
country: United States
state: Ohio
city: Norton
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Altoona
country: United States
state: Pennsylvania
city: Harleysville
country: United States
state: Pennsylvania
city: Jenkintown
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: North Myrtle Beach
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Georgetown
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: North Richland Hills
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Waco
country: United States
state: Texas
city: Burke
country: United States
state: Virginia
city: Hampton
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Carolina
country: Puerto Rico
city: Fajardo
country: Puerto Rico
city: Ponce
country: Puerto Rico
city: Rio Grande
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Incyte Corporation
name: Bill Williams, MD
role: STUDY_DIRECTOR
References:
citation: Rosenstock J, Banarer S, Fonseca VA, Inzucchi SE, Sun W, Yao W, Hollis G, Flores R, Levy R, Williams WV, Seckl JR, Huber R; INCB13739-202 Principal Investigators. The 11-beta-hydroxysteroid dehydrogenase type 1 inhibitor INCB13739 improves hyperglycemia in patients with type 2 diabetes inadequately controlled by metformin monotherapy. Diabetes Care. 2010 Jul;33(7):1516-22. doi: 10.2337/dc09-2315. Epub 2010 Apr 22.