At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of type 2 diabetes mellitus
- ✓Antidiabetic therapy: either drug-naïve or on a single oral antidiabetic agent
- ✕Any underlying or significant active disease that would prevent safe study participation at investigator discretion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Denagliptin, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus Followed by a 12-week Active Treatment Extension
In Brief
A Phase 2 clinical trial evaluating Placebo, DEN 2.5 mg, and 4 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 375 participants across 109 sites in 10 countries.
Detailed Summary
This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.
Study Details
Timeline
Interventions
Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.