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:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT03033433
Brief Summary:
An Open-Label Phase I Study to Assess the Safety and Tolerability Profile of Three Escalating Doses of DCB-DM101 in Healthy Volunteers and Optimum Dose of DCB-DM101 as Add-on Treatment in Type 2 Diabetes Mellitus (T2DM) Patients
Detailed Description:
This is a single center, open-label, phase-I study consisting of two stages: Stage 1 will be dose-escalation study to assess the safety and tolerability profile of three escalating doses of DCB-DM101 in healthy volunteers and Stage 2 will apply optimum dose of DCB-DM101 as add-on treatment in T2DM patients. In Stage 2, patients are allowed to receive metformin for T2DM for routine use of which the dosing regimen should not be adjusted. No other medication/treatments for T2DM are allowed. Stage 2 can only be proceeded upon the approval of health authority in Taiwan. After determining the optimal dose for Stage 2, the reasons for determining such dose together with relevant supporting data should be submitted to health authority in Taiwan for review and to determine whether stage 2 can be proceeded and which dose should be employed for stage 2.
Study:
NCT03033433
Study Brief:
Protocol Section:
NCT03033433