Clinical trial NCT00698789: Evaluate the Safety and Tolerability of INCB019602 When Administered With Metformin in Patients With Type 2 Diabetes
Official title: A Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety and Tolerability of INCB019602 Plus Metformin Compared to Metformin Alone in Type 2 Diabetic Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 INCB019602 administered as an add-on to stable dose metformin therapy in type 2 diabetic subjects on safety and glycemic control.


Eligibility criteria: Inclusion Criteria:

* Established diagnosis of T2D
* Currently taking metformin monotherapy at a stable dose level
* FPG between 150 and 270 mg/dL

Exclusion Criteria:

* History or clinical manifestations of renal impairment
* Hyperglycemia \> 270 mg/dL
* Receiving thiazolidenediones, Exenatide or sulfonylureas within 90 days prior to screening
* Prior use of Acipimox which is known under the name Olbetam within 90 days prior to screening.
* Diagnosed major depression within the last 2 years requiring hospitalization
* History of chronic insulin therapy for glycemic control

Primary outcomes:
measure: Safety and tolerability as determined by monitoring of AEs, vital signs, ECGs, physical examinations, and clinical laboratory blood and urine parameters.
timeFrame: End of Study
Secondary outcomes:
measure: Change from Baseline in fasting plasma glucose and population pharmacokinetics of INCB019602 in type 2 diabetic patients.
timeFrame: End of Study
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Chula Vista
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Orange
country: United States
state: California
city: Paramount
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Tustin
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: St. Petersburg
country: United States
state: Florida
city: Shawnee Mission
country: United States
state: Kansas
city: Shreveport
country: United States
state: Louisiana
city: Dearborn
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Elizabeth
country: United States
state: New Jersey
city: Charlotte
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: East Providence
country: United States
state: Rhode Island
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Incyte Corporation
name: William V Williams, MD
role: STUDY_DIRECTOR
References: