A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)
Status and phase
Completed
Phase 3
Conditions
Diabetes Mellitus, Non-Insulin-Dependent
Type 2 Diabetes Mellitus, Non Insulin Dependent
Treatments
Drug: open-label metformin
Drug: Comparator: glimepiride
Drug: sitagliptin
Details and patient eligibility
About
A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.
Enrollment
1,035 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- 18 years or older
- Diagnosed with type 2 diabetes
- On a stable dose of metformin of at least 1500 mg per day
Exclusion criteria
- History of type 1 diabetes
- Pregnant
- HIV positive
- On a weight loss program or medication
- Has a history of blood disorder, certain cancers, heart, liver or kidney disease
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
1,035 participants in 2 patient groups
1
Experimental group
Description:
sitagliptin
Treatment:
Drug: sitagliptin
Drug: open-label metformin
2
Active Comparator group
Description:
glimepiride
Treatment:
Drug: open-label metformin
Drug: Comparator: glimepiride
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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