Phase 3 N=741 Randomized Double-blind Treatment

Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT00087516 ↗

Enrolled (actual)

741

Serious AEs

9.7%

Results posted

Jun 2010

Primary outcome: Primary: Change From Baseline in A1C at Week 24 — -0.61; -0.76; 0.18 Percent — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Sitagliptin (MK0431) (Drug); Sitagliptin (Drug); Placebo (Drug); Metformin - Rescue (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Jul 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in A1C at Week 24	-0.61; -0.76; 0.18	<0.001 sig
SECONDARY Change From Baseline in FPG at Week 24	-12.4; -16.6; 4.7	<0.001 sig
SECONDARY Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24	-48.9; -56.3; -2.2	<0.001 sig
SECONDARY Change From Baseline in A1C at Week 104	-0.27; -0.40; -0.32; -0.34	—
SECONDARY Change From Baseline in FPG at Week 104	-1.8; -5.7; -4.1; -4.1	—
SECONDARY Change From Baseline in 2-hr PMG at Week 104	-30.5; -41.5; -38.3; -35.5	—

Summary

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Eligibility Criteria

Inclusion Criteria

Patients with type 2 diabetes mellitus
Patient is not pregnant or breastfeeding
Male or female patient unlikely to conceive
Patient not on an antihyperglycemic drug

Exclusion Criteria

Patient has history of type 1 diabetes mellitus
Patient has history of ketoacidosis
Patient requires insulin within 8 weeks prior to start of study
Patient on weight loss program and is not in maintenance phase
Patient taking weight loss medication within 8 weeks prior to start of study
Patient on or likely to require = 14 days or repeated courses of corticosteroids
Patient taking immunosuppressive/immunomodulating medication
Patient taking digoxin or other cardiac medication
Patient has undergone surgical general anesthesia within 30 days prior to start of study
Patient taking investigational drug within 8 weeks prior to start of study
Patient is diagnosed with liver disease
Patient has chronic myopathy, progressive neurological/neuromuscular disorder
Patient has with severe cardiac conditions within the last 6 months
Patient is Human immunodeficiency virus (HIV) positive
Patient has hematological disorder
Patient has history of malignancy
Patient has history of alcohol or drug abuse within the past 3 years

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00087516). 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.