Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00542009 | A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight | PHASE2 | COMPLETED | 252 | — | — | Dec 1, 2007 | Nov 1, 2008 | Nov 7, 2012 | 54 | United States, Bulgaria +5 |
| Arm | Type | Description |
|---|---|---|
| CE-326,597 100 mg QD | EXPERIMENTAL | - |
| CE-326,597 50 mg QD | EXPERIMENTAL | - |
| CE-326,597 25 mg QD | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| CE-326,597 5mg QD | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CE-326,597 100 mg QD | DRUG | Administered orally, once daily with morning meal for duration of trial (84 days). |
| CE-326,597 50 mg QD | DRUG | Administered orally, once daily with morning meal for duration of trial (84 days). |
| CE-326,597 25 mg QD | DRUG | Administered orally, once daily with morning meal for duration of trial (84 days). |
| Placebo | DRUG | Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days). |
| CE-326,597 5mg QD | DRUG | Administered orally, once daily with morning meal for duration of trial (84 days). |
Inclusion Criteria: Patients with type 2 diabetes, not on any or on oral (up to 2) anti-diabetic medications, otherwise medically stable. Exclusion Criteria: Women of childbearing potential, people with unstable medical conditions, people with gallstones