Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics
Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00698230
Collaborator
(none)
302
68
6
12
4.4
0.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
302 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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 Start Date
:
May 1, 2008
Actual Primary Completion Date
:
Apr 1, 2009
Actual Study Completion Date
:
May 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment A - INCB013739 & Metformin INCB013739 5 mg QD and Metformin |
Drug: INCB013739
INCB013739 5 mg QD tablet
Drug: Metformin
|
| Experimental: Treatment B - INCB013739 & Metformin INCB013739 15 mg QD and Metformin |
Drug: INCB013739
INCB013739 15 mg QD tablet
Drug: Metformin
|
| Experimental: Treatment C - INCB013739 & Metformin INCB013739 50 mg QD and Metformin |
Drug: INCB013739
INCB013739 50 mg QD tablet
Drug: Metformin
|
| Experimental: Treatment D - INCB013739 & Metformin INCB013739 100 mg QD and Metformin |
Drug: INCB013739
INCB013739 100 mg QD tablet
Drug: Metformin
|
| Experimental: Treatment E - INCB013739 & Metformin INCB013739 200 mg QD and Metformin |
Drug: INCB013739
INCB013739 200 mg QD
Drug: Metformin
|
| Placebo Comparator: Treatment F - Placebo Matching placebo |
Drug: Placebo comparator matching INCB013739
Orally once daily tablet
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline to Week 12 in hemoglobin A1c (HbA1c) [Baseline and Week 12 (or early termination study visit)]
Secondary Outcome Measures
- Change from Baseline to Week 12 in fasting plasma glucose (FPG). [Baseline and Week 12 (or early termination study visit)]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | 35242 | |
| 2 | Artesia | California | United States | ||
| 3 | Calabasas | California | United States | 91307 | |
| 4 | Fresno | California | United States | 93720 | |
| 5 | Los Angeles | California | United States | 90057 | |
| 6 | Los Gatos | California | United States | 95032 | |
| 7 | Santa Ana | California | United States | ||
| 8 | Colorado Springs | Colorado | United States | 80909 | |
| 9 | Chiefland | Florida | United States | 32626 | |
| 10 | Hollywood | Florida | United States | 33021 | |
| 11 | Longwood | Florida | United States | 32779 | |
| 12 | Miami Beach | Florida | United States | 33140 | |
| 13 | Miami | Florida | United States | 33126 | |
| 14 | Ocala | Florida | United States | 34471 | |
| 15 | Orlando | Florida | United States | 32806 | |
| 16 | South Miami | Florida | United States | 33143 | |
| 17 | Tampa | Florida | United States | 33614 | |
| 18 | Dunwoody | Georgia | United States | 30338 | |
| 19 | Rome | Georgia | United States | 30165 | |
| 20 | Belleville | Illinois | United States | 62220 | |
| 21 | Shawnee Mission | Kansas | United States | 66216 | |
| 22 | Bangor | Maine | United States | 04401 | |
| 23 | Columbia | Maryland | United States | 21045 | |
| 24 | Sterling Heights | Michigan | United States | 48314 | |
| 25 | Florissant | Missouri | United States | 63031 | |
| 26 | Saint Louis | Missouri | United States | 63128 | |
| 27 | Saint Louis | Missouri | United States | 63141 | |
| 28 | Las Vegas | Nevada | United States | 89101 | |
| 29 | New York | New York | United States | 10016 | |
| 30 | Springfield Gardens | New York | United States | 11413 | |
| 31 | West Seneca | New York | United States | 14224 | |
| 32 | Calabash | North Carolina | United States | 95032 | |
| 33 | Mooresville | North Carolina | United States | 28117 | |
| 34 | New Bern | North Carolina | United States | 28562 | |
| 35 | Winston-Salem | North Carolina | United States | 27103 | |
| 36 | Kettering | Ohio | United States | 45429 | |
| 37 | Norton | Ohio | United States | 44614 | |
| 38 | Norman | Oklahoma | United States | 73071 | |
| 39 | Altoona | Pennsylvania | United States | 16601 | |
| 40 | Harleysville | Pennsylvania | United States | 19438 | |
| 41 | Jenkintown | Pennsylvania | United States | 19046 | |
| 42 | Sellersville | Pennsylvania | United States | 18960 | |
| 43 | Greenville | South Carolina | United States | 29615 | |
| 44 | North Myrtle Beach | South Carolina | United States | 29582 | |
| 45 | Spartanburg | South Carolina | United States | 29303 | |
| 46 | Bristol | Tennessee | United States | 37620 | |
| 47 | Austin | Texas | United States | 78705 | |
| 48 | Dallas | Texas | United States | 75230 | |
| 49 | Georgetown | Texas | United States | ||
| 50 | Houston | Texas | United States | 77004 | |
| 51 | Houston | Texas | United States | 77023 | |
| 52 | Houston | Texas | United States | 77074 | |
| 53 | Houston | Texas | United States | 77081 | |
| 54 | Houston | Texas | United States | 77090 | |
| 55 | Midland | Texas | United States | 79705 | |
| 56 | North Richland Hills | Texas | United States | 76180 | |
| 57 | San Antonio | Texas | United States | 78229 | |
| 58 | Temple | Texas | United States | 76502 | |
| 59 | Waco | Texas | United States | 76710 | |
| 60 | Burke | Virginia | United States | 22015 | |
| 61 | Hampton | Virginia | United States | 23666 | |
| 62 | Milwaukee | Wisconsin | United States | 53209 | |
| 63 | Carolina | Puerto Rico | 00983 | ||
| 64 | Fajardo | Puerto Rico | 00738 | ||
| 65 | Ponce | Puerto Rico | 00716 | ||
| 66 | Rio Grande | Puerto Rico | 00745 | ||
| 67 | San Juan | Puerto Rico | 00909-1711 | ||
| 68 | San Juan | Puerto Rico | 00926-2832 |
Sponsors and Collaborators
- Incyte Corporation
Investigators
- Study Director: Bill Williams, MD, Incyte Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00698230
Other Study ID Numbers:
- INCB 13739-202
First Posted:
Jun 17, 2008
Last Update Posted:
Feb 14, 2018
Last Verified:
Feb 1, 2018
Additional relevant MeSH terms: