Diabetes
Safety and efficacy of INCB013739 plus metformin compared to metformin alone on glycemic control in type 2 diabetics
Incyte Study ID:
INCB 13739-202
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Clinical Study Purpose
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.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
May 2008 - Apr 2009
TYPE
Interventional
PHASE
Phase 2
SEX
Female & Male
AGE
18 - 75 Years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Location
Status
Location
Birmingham, AL, US, 35242
Status
Completed
Location
Artesia, CA, US
Status
Completed
Location
Calabasas, CA, US, 91307
Status
Completed
Location
Fresno, CA, US, 93720
Status
Completed
Location
Los Angeles, CA, US, 90057
Status
Completed
Location
Los Gatos, CA, US, 95032
Status
Completed
Key Inclusion and Exclusion 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
Protocol Summary
Incyte Study ID:
INCB 13739-202
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Interventions:
Drug
Enrollment:
302
Primary Outcome
Open
Change from Baseline to Week 12 in hemoglobin A1c (HbA1c)
Timeframe: Baseline and Week 12 (or early termination study visit)
Secondary Outcome
Open
Change from Baseline to Week 12 in fasting plasma glucose (FPG).
Timeframe: Baseline and Week 12 (or early termination study visit)