Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT01147861
Brief Summary:
The aim of this study is to verify whether a significant decrease in glucose levels can be achieved with the HM74A agonist GSK256073 in type 2 diabetic patients. Several dose levels and a placebo will be evaluated in a three period crossover study with two active doses and one placebo dose per subject, in order to determine whether there is a dose that produces glucose lowering in the target population. In addition, this study will investigate the optimal dosing regimen for full manifestation of any metabolic effect of GSK256073 by comparing once a day versus twice a day regimens.
Detailed Description:
This is a multi-center study that will enroll approximately 36 subjects. The study consists of three periods of two days of dosing each. The study will evaluate 5 potential dose regimens. Each subject will receive a randomized sequence of treatments over three periods, with placebo treatment in one period and two different active dose regimens in the other two periods. There will be 5 to 12 days of outpatient washout between treatment periods. Subjects will continue their current treatment on metformin throughout the study. Subjects will monitor blood glucose levels daily via glucometer during oupatient washout periods. A follow-up visit will occur between 5 and 10 days after the last period of the study.
Study:
NCT01147861
Study Brief:
Protocol Section:
NCT01147861