A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of KRP-104 in Patients With Type 2 Diabetes Inadequately Controlled on Metformin Alone
Lead SponsorActivX Biosciences, Inc.
StatusCompleted No Results Posted
Indication/ConditionType 2 Diabetes
Intervention/Treatmentkrp-104 sitagliptin ...
To assess the safety and efficacy of chronic therapy with KRP-104, a novel DPP-IV inhibitor, in patients with Type 2 Diabetes on stable metformin therapy. In addition, an estimate of how much of the HbA1c response is attributable to nocturnal coverage will be explored.
KRP-104 120 mg: KRP-104 two 50 mg tablets and two 10 mg tablets 15 to 30 minutes before morning meal and 2 placebo tablets 15 to 30 minutes before evening meal
Two tablets 15 to 30 minutes before each meal, morning and evening.
KRP-104 60 mg: KRP-104 one 50 mg tablet plus one 10 mg tablet 15 to 30 minutes before each meal, morning and evening.
Inclusion Criteria: Age 18 to 70 years, inclusive; Males and females of non-childbearing potential; Diagnosis of type 2 diabetes mellitus according; and On a stable dose of metformin monotherapy at randomization (can be on other oral therapies or naive at study entry Exclusion Criteria: History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia; History or presence of alcoholism or drug abuse Typical consumption of ≥10 drinks of alcohol weekly; Presence of any of the following conditions: Significant renal impairment (glomerular filtration rate <60 mL/min [to be calculated by the central laboratory]); Diabetic retinopathy; Diabetic gastroparesis; Active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, or symptomatic gallbladder disease; Uncontrolled high blood pressure; History or evidence of cardiovascular or pulmonary disease Must meet other laboratory and Medical History clinical criteria. Please contact recruitment center for referrals