Phase 3
N=91
An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (0431-028)(COMPLETED)
Diabetes Mellitus, Type 2 · Chronic Renal Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT00095056 ↗Enrolled (actual)
91
Serious AEs
33.0%
Results posted
Jul 2010
Primary outcome: Primary: Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment — 41; 16; 8; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- sitagliptin (Drug); Placebo to Sitagliptin (Drug); glipizide (Drug); Placebo to glipizide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jul 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment |
41; 16; 8; 1; 9; 1 | — |
| SECONDARY Safety and Tolerability of Sitagliptin Over 54 Weeks |
50; 22; 8; 5; 20; 10 | — |
Summary
The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function).
Eligibility Criteria
Inclusion Criteria
- Patients who are at least 18 years of age diagnosed with type 2 diabetes mellitus (T2DM) (a specific type of diabetes).
- Patient has renal (kidney) insufficiency (inadequate kidney function)
Exclusion Criteria
- Patient has had heart problems (such as a heart attack or chest pain) or stroke within the past 6 months or any condition or therapy which, in the opinion of the investigator, may not be in the patient's best interest to participate.
- Pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT00095056). 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.