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Clinical Trial Details

Trial ID: L3690
Source ID: NCT02477969
Associated Drug: Pex168(100µg)
Title: Efficacy and Safety Study of PEX168 in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: PEX168(100µg)|DRUG: PEX168(200µg)|DRUG: Placebo|DRUG: Metformin
Outcome Measures: Primary: HbA1c, HbA1c change from baseline to treatment Week 24 when receiving PEX 168 combined with metformin hydrochloride as compared to the placebo combined with metformin hydrochloride;PEX 168 as compared to the placebo, given on the basis of diet control and exercise., Baseline to Week24 | 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., Baseline to Week24|Fasting plasma glucose, Baseline to Week52|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., Baseline to Week52|Postprandial blood glucose two hours, Baseline to Week52|Postprandial blood glucose two hours AUC, Baseline to Week52|Lipid, Baseline to Week52|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., Baseline to Week52|Blood pressure, Collect blood pressure data in the morning of screening period, baseline,4,8,12,18,24,38,52 weeks by standardized procedure., Baseline to Week52|Number of Participants with Adverse Events as a Measure of Safety and Tolerability, Baseline to Week 56
Sponsor/Collaborators: Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 587
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-02-27
Completion Date: 2017-06
Results First Posted:
Last Update Posted: 2017-01-24
Locations: Shanghai sixth People's Hospital, Shanghai, Shanghai, 200233, China
URL: https://clinicaltrials.gov/show/NCT02477969