Phase 3
N=521
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00094757 ↗Enrolled (actual)
521
Serious AEs
7.1%
Results posted
Jul 2010
Primary outcome: Primary: Change From Baseline in A1C at Week 18 — -0.48; -0.36; 0.12 percent — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Comparator: sitagliptin 100 mg (Drug); Comparator: sitagliptin 200 mg (Drug); Comparator: placebo (Drug); Comparator: pioglitazone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Aug 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in A1C at Week 18 |
-0.48; -0.36; 0.12 | <0.001 sig |
| SECONDARY Change From Baseline in FPG at Week 18 |
-12.7; -9.9; 7.0 | <0.001 sig |
| SECONDARY Change From Baseline in A1C at Week 54 |
-0.28; -0.19; -0.87 | — |
| SECONDARY Change From Baseline in FPG at Week 54 |
-5.5; -0.7; -28.0 | — |
Summary
The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.
Eligibility Criteria
Inclusion Criteria
- Patients at least 18 years of age and not older than 75 who have a specific type of diabetes called Type 2 Diabetes Mellitus
Exclusion Criteria
- Younger than 18 years of age or older than 75
- Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate
Data sourced from ClinicalTrials.gov (NCT00094757). 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.