|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Incyte Corporation |
| Information provided by: | Incyte Corporation |
| ClinicalTrials.gov Identifier: | NCT00698230 |
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.
| Condition | Intervention | Phase |
|
Type 2 Diabetes |
Drug: INCB013739 Drug: Placebo |
Phase II |
| MedlinePlus related topics: | Diabetes |
| Drug Information available for: | Metformin Metformin hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 300 |
| Study Start Date: | May 2008 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Dose 1 INCB013739
|
Drug: INCB013739
INCB013739 tablet form
|
|
2: Experimental
Dose 2 INCB013739
|
Drug: INCB013739
INCB013739 tablet form
|
|
3: Experimental
Dose 3 INCB013739
|
Drug: INCB013739
INCB013739 tablet form
|
|
4: Experimental
Dose 4 INCB013739
|
Drug: INCB013739
INCB013739 tablet form
|
|
5: Experimental
Dose 5 INCB013739
|
Drug: INCB013739
INCB013739 tablet form
|
| 6: Placebo Comparator |
Drug: Placebo
Placebo Tablet
|
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Robert Flores | 302-498-6949 | rflores@incyte.com |
![]() |
Show 68 Study Locations |
| Incyte Corporation |
More Information
| Responsible Party: | Incyte Corporation ( Pam Murphy, VP Investor Relations and Corporate Communication ) |
| Study ID Numbers: | INCB 13739-202 |
| First Received: | June 13, 2008 |
| Last Updated: | August 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00698230 |
| Health Authority: | United States: Food and Drug Administration |
|
|
|