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Clinical Trial Details

Trial ID: L3165
Source ID: NCT02477865
Associated Drug: Pex168(100µg)
Title: Efficacy and Safety Study of PEX168 in Monotherapy Diabetes Mellitus Type 2 Patients
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: PEX168(100µg)|DRUG: PEX168(200µg)|DRUG: Placebo
Outcome Measures: Primary: HbA1c, To evaluate the HbA1c change from baseline to treatment Week 24 when receiving PEX 168 as compared to the placebo, given on the basis of diet control and exercise., Baseling to 24 weeks | Secondary: The proportion of HbA1c <6.5% and <7% at the end of the analysis., The proportion of HbA1c \<6.5% and \<7% at the end of the analysis, and the proportion receiving salvage therapy., Baseling to 24 weeks|Fasting plasma glucose, Baseling to 52 weeks|6 points glucose of fingertip, Each test point of time was before breakfast, 2 hours after breakfast, before lunch,2 hours after lunch , dinner, 2 hours after dinner.This test was performed four times including baseline,V19,V31 and V59., Baseling to 24 and 52 weeks|Postprandial blood glucose two hours, Baseling to 24 weeks|Postprandial blood glucose two hours AUC, Baseling to 24 weeks|Lipid, Baseling to 52 weeks|Weight measured by standardized procedure., Collect weight data in the morning of screening period, baseline,4,8,12,18,24,38,52 weeks by standardized procedure., Baseling to 52 weeks|Blood pressure, Collect blood pressure data in the morning of screening period, baseline,4,8,12,18,24,38,52 weeks by standardized procedure., Baseling to 52 weeks|Number of Participants with Adverse Events as a Measure of Safety and Tolerability, Baseling to 56 weeks
Sponsor/Collaborators: Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 406
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-03-23
Completion Date: 2017-02
Results First Posted:
Last Update Posted: 2017-01-24
Locations:
URL: https://clinicaltrials.gov/show/NCT02477865