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
Completed · Phase 2 · Has a placebo group
Conditions studied: Type 2 Diabetes
In brief
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.
Key facts
- Study ID
- NCT00525330
- Run by
- ActivX Biosciences, Inc.
- People needed
- 213
- Starts
- 2007-09-01
- Expected to finish
- 2008-08-01
- Last updated by the study team
- 2013-08-22
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — San Diego, California, United States
Full record on ClinicalTrials.gov
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