Status:
COMPLETED
A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the effectiveness and safety of 12 weeks of treatment with R256918 in patients with Type 2 Diabetes Mellitus who are taking metformin. The primary measure o...
Detailed Description
This is a randomized (assigned study drug by chance), double-blind (both the patient and investigator do not know whether patient is assigned to receive study drug or placebo), placebo-controlled stud...
Eligibility Criteria
Inclusion
- History of Type 2 Diabetes Mellitus and treated with a stable dose of metformin for at least 2 months
- Women must be postmenopausal or surgically incapable of childbearing or if sexually active, be practicing an effective method of birth control
- BMI between 25 and 45 kg/m2
- HbA1c between 7% and 10%, inclusive
- Fasting plasma glucose not exceeding 240mg/dL (13.3mmol/L)
Exclusion
- Diabetes other than type 2 diabetes mellitus
- Treatment with oral anti-diabetic agents (other than metformin) or insulin during the 12 weeks before baseline visit
- History of intolerance or hypersensitivity to sulfonylurea or sitagliptin
- History of clinically significant gastrointestinal, hepatic or cardiovascular disease
- Active proliferative diabetic retinopathy
- History of diabetic gastroparesis
- concurrent use of systemic corticosteroid
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT00672386
Start Date
December 1 2007
End Date
September 1 2008
Last Update
July 14 2014
Active Locations (62)
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1
Edegem, Belgium
2
Hellerup, Denmark
3
Vipperroed, Denmark
4
Helsinki, Finland