NCT03033433

DCB-DM101 in Healthy Volunteers and for Type 2 Diabetes Mellitus Patients

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: VitNovo, Inc. · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
DRUG	DCB-DM101	determination of optimal dose for Stage 2

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-12-01
• Completion: 2018-08-01
• First posted: 2017-01-26
• Last updated: 2018-10-16

Locations

1 site across 1 country: Taiwan