An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)
- Registration Number
- NCT00094770
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).
- Detailed Description
The duration of treatment is 104 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1172
- Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sitagliptin 100 mg sitagliptin (MK0431) Sitagliptin 100 mg oral tablets of sitagliptin once daily.
- Primary Outcome Measures
Name Time Method Change From Baseline in HbA1c at Week 52 Baseline and Week 52 HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent.
- Secondary Outcome Measures
Name Time Method Change From Baseline in HbA1c at Week 104 Baseline and Week 104 HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
Hypoglycemic Events at Week 52 Baseline to Week 52 Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia.
Number of Participants With Serious CAEs at Week 104 Baseline to Week 104 Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104 Baseline to Week 104 A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Change From Baseline in Body Weight at Week 52 Baseline and Week 52 Change from baseline at Week 52 is defined as Week 52 minus Week 0.
Change From Baseline in Body Weight at Week 104 Baseline and Week 104 Change from baseline at Week 104 is defined as Week 104 minus Week 0.
Number of Participants With Serious LAEs at Week 104 Baseline to Week 104 Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Number of Participants With Drug-related LAEs at Week 104 Baseline to Week 104 Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs.
Hypoglycemic Events at Week 104 Baseline to Week 104 Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia.
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104 Baseline to Week 104 An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Number of Participants With Drug-related CAEs at Week 104 Baseline to Week 104 Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.