An Open-label Study to Assess the Safety and Tolerability of JANUVIA (Sitagliptin) in 30 Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
Overview
- Phase
- Phase 3
- Intervention
- Sitagliptin phosphate
- Conditions
- Type 2 Diabetes
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 30
- Primary Endpoint
- Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants with T2DM failing metformin monotherapy
- •Between the ages of 18 and 79
Exclusion Criteria
- •Participants has a history of type 1 Diabetes Mellitus or ketoacidosis
Arms & Interventions
Sitagliptin
Sitagliptin as add-on therapy to a stable dose of metformin
Intervention: Sitagliptin phosphate
Sitagliptin
Sitagliptin as add-on therapy to a stable dose of metformin
Intervention: Metformin
Outcomes
Primary Outcomes
Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment
Time Frame: 4 weeks
Safety \& tolerability were measured in terms of the # of participants with \>=1 adverse event (AE), \>=1 drug-related AE, \>=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.
Secondary Outcomes
- Change From Baseline in Fasting Plasma Glucose at Week 4(Baseline and Week 4)