A Study of Single Doses of RO4998452 in Patients With Type 2 Diabetes
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This randomized, double-blind, placebo-controlled, cross-over study will evaluate the glucose concentration and other glycemic parameters of efficacy, and the safety and tolerability and pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2. On 3 treatment days a week apart, patients will each receive orally one of 2 dose levels of RO4998452 or placebo. Anticipated time of study treatment is 3 weeks. Target sample size is <50.
A Single-center, Double-blind, Randomized, Cross-over, Placebo-controlled, Single-dose Study to Investigate Glycemic Parameters of Efficacy During 24 Hours, Safety/ Tolerability and Pharmacokinetics of Two Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus
Study Start Date :
Actual Primary Completion Date :
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult patients, 18-75 years of age
Type 2 diabetes mellitus, diagnosed for at least 3 months at screening
Treatment with diet and exercise
BMI between 27 and 40 kg/m2
Type 1 diabetes
History of ketoacidosis, hyperosmolar coma, or lactic acidosis
Renal disease or renal dysfunction
Evidence of significant diabetic complication
Currently or within 3 months prior to screening treated with any oral or injectable anti-diabetic agents (exception: insulin injection in emergency situation)