Phase 2 N=80 Randomized Double-blind Treatment

Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

Diabetes Mellitus, Non-Insulin-Dependent

Bottom Line

View on ClinicalTrials.gov: NCT00758069 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Sep 2009

Primary outcome: Primary: Change From Baseline in 24-hour Weighted Mean Plasma Glucose — -34.9; -28.6; -9.0 mg/dL — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: sitagliptin phosphate (Drug); Comparator: Placebo (Drug); Comparator: Sitagliptin (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Feb 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in 24-hour Weighted Mean Plasma Glucose	-34.9; -28.6; -9.0	<0.001 sig
SECONDARY Change From Baseline in Plasma Glucose	-22.3; -16.0; -3.1	<0.001 sig

Summary

A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

Eligibility Criteria

Inclusion Criteria

Patients Have Type 2 Diabetes Mellitus On Diet/Exercise Therapy

Exclusion Criteria

Patients Have Type 1 Diabetes Mellitus

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00758069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.