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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00256867 | A Study In Patients With Type 2 Diabetes Mellitus | PHASE3 | COMPLETED | 369 | — | — | Aug 18, 2005 | Oct 31, 2006 | Jul 2, 2018 | 85 | United States, Australia +4 |
Median percent change from Baseline to Week 6 in LDL-c in FDC and RSG monotherapy was reported. Percent change from Baseline = 100\*(exponent \[change on log scale\]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of an analysis of covariance (ANCOVA) with terms for treatment, gender, current sulfonylurea use (at baseline), country, and Baseline measurement. ANCOVA for LDL-c were performed based on log-transformed data.
| Name | Type | Description |
|---|---|---|
| GSK523338 | DRUG | - |
Inclusion criteria: * A clinical diagnosis type 2 diabetes mellitus. * Women must not be pregnant or breastfeeding during the study and 30 days after the study. * Must sign an informed consent form at the study clinic. Exclusion criteria: * Severe chronic diseases that would prevent from particip...