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Clinical Trial Details

Trial ID: L4246
Source ID: NCT02606617
Associated Drug: Mosapride
Title: A Clinical Trial Analyzing Effects of Prokinetic Drug on the Blood Glucose in Patients With Type 2 Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Mosapride|DRUG: Placebo
Outcome Measures: Primary: Change of fasting plasma glucose (FPG,mmol/L), Baseline, 24weeks (End of Trial)|Change of OGTT 2 hour blood glucose(mmol/L), Baseline, 24weeks (End of Trial)|Change of HbA1c(%), Baseline, 24weeks (End of Trial)|Change of control rate of blood glucose(%), Baseline, 24weeks (End of Trial) | Secondary: Change of insulin release(uU/mL), Baseline, 24weeks (End of Trial)|Change of C peptide release(nmol/L), Baseline, 24weeks (End of Trial)|Change of HOMA-β[HOMA-β=20×(FINS,mIU/L)/((FPG,mmol/L)-3.5)], Baseline, 24weeks (End of Trial)|Change of HOMA-IR [HOMA-IR=(FPG,mmol/L)×(FINS,mIU/L)/22.5], Baseline, 24weeks (End of Trial)|Change of blood glucose variability(%), Baseline, 24weeks (End of Trial)|Change of triglyceride(mmol/L), Baseline, 24weeks (End of Trial)|Change of total cholesterol(mmol/L), Baseline, 24weeks (End of Trial)|Change of LDL-c(mmol/L), Baseline, 24weeks (End of Trial)|Change of HDL-c(mmol/L), Baseline, 24weeks (End of Trial)|Change of Glucagon(pg/ml)., Baseline, 24weeks (End of Trial)|Change of GLP(pg/ml)., Baseline, 24weeks (End of Trial)|Change of GIP(pg/ml)., Baseline, 24weeks (End of Trial)|Change of DPP-IV(pg/ml)., Baseline, 24weeks (End of Trial)|Change of waist circumference (WC,cm), Baseline, 24weeks (End of Trial)|Change of body mass index (BMI=weight(kg)/[height(m)2], kg/m2), Baseline, 24weeks (End of Trial)|Change of body fat(%)., Baseline, 24weeks (End of Trial)|Change of carotid intima-media thickness (IMT,mm)., Baseline, 24weeks (End of Trial)|Change of 24-hours urine sodium(mmol/24h), Baseline, 24weeks (End of Trial)|Change of 24-hours microalbumin(mg/L)., Baseline, 24weeks (End of Trial)|Change of 24-hours mALB/Cr(mg/g.Cr)., Baseline, 24weeks (End of Trial)|Change of inflammatory markers(hs-CRP,mg/L)., Baseline, 24weeks (End of Trial)|Incidence rate of newly-diagnosed hypertension(%)., Baseline, 24weeks (End of Trial)|Heart rate variability(HRV,%)., Baseline, 24weeks (End of Trial)|Change of clinic blood pressure and 24h mean blood pressure(mmHg)., Baseline, 24weeks (End of Trial)
Sponsor/Collaborators: Sponsor: Third Military Medical University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 200
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-12
Completion Date: 2016-12
Results First Posted:
Last Update Posted: 2015-11-17
Locations:
URL: https://clinicaltrials.gov/show/NCT02606617