A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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 of effectiveness is the change in concentration of glycated hemoglobin (HbA1c) during treatment. Glycated hemoglobin is a substance in red blood cells that is formed when blood sugar (glucose) attaches to hemoglobin and is a measure of diabetic status. Additional measures include fasting glucose, and lipid levels, and body weight. Safety assessments performed during the trial include laboratory tests, vital sign measurements, and adverse event reporting.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Metformin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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