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Clinical Trial Details

Trial ID: L7225
Source ID: NCT03033433
Associated Drug: Dcb-Dm101
Title: DCB-DM101 in Healthy Volunteers and for Type 2 Diabetes Mellitus Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type2 Diabetes
Interventions: DRUG: DCB-DM101
Outcome Measures: Primary: Stage 1: Optimal dose for Stage 2, dose limiting toxicity (DLT), Primary endpoint, DLT is defined as: Any causally related adverse event as judged by investigator is greater than or equal to Grade 2. The causality of each adverse event to investigational product will be judged by investigator during the conduction of each dosing cohort in Stage I. DSMB will reevaluate the causality of each DLT after the completion or termination of this dosing cohort judged by investigator to determine whether dose escalation or entering to stage 2 can be proceeded.Optimal Dose will be one tablet or two tablets or 4 tablets. the optimal dose for stage 2 is defined using rules as follows but will be determined by sponsor and investigators., 7 months|Stage 2: Number of Participants with Adverse events and Serious adverse events that are related to treatment, Specified:Primary endpoint, An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study medication, whether or not related to the study medication. A Serious Adverse Event is defined as an AE meeting one of the following conditions. Death during the period of protocol defined surveillance. Life threatening Event defined as a participant at immediate risk of death at the time of the event. An event requiring inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance. Results in congenital anomaly or birth defect. Results in a persistent or significant disability and incapacity., 3 months | Secondary: Stage1: Number of Participants with Adverse events and Serious adverse events that are related to treatment, Secondary endpoint, An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study medication, whether or not related to the study medication. A Serious Adverse Event is defined as an AE meeting one of the following conditions. Death during the period of protocol defined surveillance. Life threatening Event defined as a participant at immediate risk of death at the time of the event. An event requiring inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance. Results in congenital anomaly or birth defect. Results in a persistent or significant disability and incapacity., 7 months|Stage2: Change from baseline in results of oral glucose tolerance test (OGTT), While patient takes OGTT at Screening visit, blood glucose will be monitor at right before, 0.5, 1, 1.5, and 2 hr after administration of solution containing 75 g glucose. While at visit 2 and 4, blood glucose will be monitored at pre-dose, right before taking solution containing 75 g glucose(30 mins after dosing), 1, 1.5, 2, and 2.5 hr after administration of dose., 0 (pre-dose) and 0.5, 1, 1.5, 2, 2.5 hours post-dose|Stage2: Change from baseline in biomarker( serum insulin) testing results., Biomarker consists of serum insulin. Insulin will be measured at all the same time points where blood glucose is measured including OGTT test time points for Visits 1 (-30 to 1 days), 2 (Day 1), and 4(Day 14), and single blood sampling besides laboratory test for Visits 3 (Day 8) and 5 (Day 28)., Visits 1 (-30 to 1 days), Visit 2 (Day 1), Visits 3 (Day 8), Visit 4(Day 14)and 5 (Day 28).|Stage2: Change from baseline in biomarker( serum fructosamine) testing results., Fructosamine at will be measured at Visit 1 (-30 to 1 days), Visit 3 (Day 8), Visit 4 (Day 14), and Visit 5 (Day 28)., Visit 1 (-30 to 1 days), Visit 3 (Day 8), Visit 4 (Day 14), and Visit 5 (Day 28).
Sponsor/Collaborators: Sponsor: VitNovo, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 28
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-10
Completion Date: 2018-08
Results First Posted:
Last Update Posted: 2018-10-16
Locations: Tri-Service General Hospital, Taipei, 114, Taiwan
URL: https://clinicaltrials.gov/show/NCT03033433