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Clinical Trial Details

Trial ID: L7362
Source ID: NCT01452451
Associated Drug: Hm11260c
Title: Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: HM11260C|DRUG: Placebo
Outcome Measures: Primary: Number of subjects with adverse events as a measure of safety and tolerability, Number of subjects with adverse events as a measure of safety and tolerability when given different regimens to subjects in T2DM with metformin monotherapy, Up to 106 days | Secondary: The pharmacokinetics in repeat-dose, * Before dosing on the first dosing day (Day 1) * After the first dose: 8, 24, 48, 72, 96, 120, and 144 hours after dosing * Trough samples (ie, immediately before dosing) will be taken prior to dosing on Days 8, 22, 36, 57, 71, and 85 * After the last dose (thirteenth dose) at 8, 24, 48, 72, 96, 120, and 144 hours after dosing and 7, 10, 14, 21, 28, and 35 days after dosing to define the elimination period of HM11260C, Day 1 up to Day 92|The pharmacodynamics in repeat-dose, HbA1c, glycosylated albumin, fructosamine, insulin, and fasting glucose: For all cohorts: screening; Day -1; before dosing on Days 29, 57, and 85; and at follow-up., Up to 106 days
Sponsor/Collaborators: Sponsor: Hanmi Pharmaceutical Company Limited
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 72
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2011-12
Completion Date:
Results First Posted:
Last Update Posted: 2016-08-09
Locations: Ohio, Ohio, United States
URL: https://clinicaltrials.gov/show/NCT01452451