Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK523338 · 1 trial · 1 indication
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...
GSK523338 is an investigational small molecule being developed by GSK plc for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 3 clinical development, though no regulatory approval has been granted. The drug is intended to address the metabolic condition in adult patients.
GSK523338 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 2 Diabetes Mellitus.
GSK523338 is in Phase 3 clinical development. It has completed one Phase 3 trial, but it is not yet approved by regulatory authorities. The drug remains investigational and is being studied for its potential use in treating Type 2 Diabetes Mellitus.
GSK523338 has one completed Phase 3 clinical trial registered as NCT00256867, titled 'A Study In Patients With Type 2 Diabetes Mellitus'. The trial enrolled 369 participants across the United States, Australia, Canada, Mexico, Philippines, and Puerto Rico, and included adults aged 18 years and older.
GSK523338 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for Type 2 Diabetes Mellitus. The completed Phase 3 trial (NCT00256867) has finished, but the drug has not received marketing authorization from the FDA or any other regulatory body.