A New Oral Treatment For Type II Diabetes Mellitus

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.

Timeline

Start

2005-04-28

Primary completion

2006-07-01

Completion

2006-07-21

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs DEN 7.5 mg; p <0.001; Mean Difference (Net) -0.53 (95% CI -0.82 to -0.24); ANCOVA NCT00111800 ↗

registry analysis (superiority test); Placebo vs DEN 30 mg; p <0.001; Mean Difference (Net) -0.80 (95% CI -1.09 to -0.50); ANCOVA NCT00111800 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Denagliptin	Small molecule	2.5 mg	Oral
Subject	Denagliptin	Small molecule	7.5 mg	Oral
Subject	Denagliptin	Small molecule	15 mg	Oral
Subject	Denagliptin	Small molecule	30 mg	Oral
Subject	Denagliptin	Small molecule	45 mg	Oral

Indications