Sitagliptin (MK0431)
DrugPhase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
Other names: MK0431, Januvia
NCT Number: NCT00087516
The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
Other names: MK0431, Januvia
Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
Other names: MK0431, Januvia
Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.
Other names: Metformin, Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet
Time frame: Weeks 0-24
A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Time frame: Weeks 0-24
Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG.
Time frame: Weeks 0-24
Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.
Time frame: Weeks 0-104
A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent.
Time frame: Weeks 0-104
Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG.
Time frame: Weeks 0-104
Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG.
Merck Sharp & Dohme LLC
Industry
A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of MK0431 Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05259449
Diabetes Mellitus, Diabetes Mellitus, Type 2
Puerto Real, Cadiz, Spain
View Trial DetailsNCT03899883
Diabetes, Diabetes Complications
Aurora, Colorado, United States
View Trial DetailsNCT07251504
Diabetes Mellitus, Diabetes Mellitus, Type 2
Puerto Real, Cádiz, Spain
View Trial DetailsNCT00445627
Body Weight, Diabetes Mellitus
Bethesda, Maryland, United States
View Trial Details