Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3865
Source ID: NCT02526810
Associated Drug: Insulin Lispro
Title: Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes
Acronym: COGFOST
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: insulin lispro|DRUG: Insulin Glargine
Outcome Measures: Primary: mean amplitude of glycemic excursions( MAGE), a Medtronic dynamic blood glucose meter was applied to the patient for 72 hours, and MAGE is calculated according to the data., 3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days | Secondary: glycated hemoglobin A1c, changes of HbA1c before and after the intervention, From date of randomization until the end of study, assessed up to 15 days|glycated albumin, changes of glycated albumin before and after the intervention, From date of randomization until the end of study, assessed up to 15 days|fasting plasma glucose, postprandial plasma glucose (30min, 120min), changes of fasting and postprandial plasma glucose before and after the intervention, From date of randomization until the end of study, assessed up to 15 days|Fasting C-peptide, changes of Fasting C-peptide before and after the intervention, From date of randomization until the end of study, assessed up to 15 days|Fasting insulin, changes of Fasting insulin before and after the intervention, From date of randomization until the end of study, assessed up to 15 days|Homa-β, changes of Homa-β before and after the intervention, From date of randomization until the end of study, assessed up to 15 days|insulin secretion-sensitivity index, changes of insulin secretion-sensitivity index before and after the intervention, From date of randomization until the end of study, assessed up to 15 days|disposition index, changes of disposition index before and after the intervention, From date of randomization until the end of study, assessed up to 15 days|standard deviation of glucose level, standard deviation of glucose level, during three days' CGMS|area under curve (AUC) when the glucose level was higher than 7.8mmol/L, AUC when the glucose level was higher than 7.8mmol/L, during three days' CGMS|area under curve (AUC) when the glucose level was lower than 3.9mmol/L, AUC when the glucose level was higher than 3.9mmol/L, during three days' CGMS|thiobarbituric acid reactive substance, changes of thiobarbituric acid reactive substance before and after the intervention, From date of randomization until the end of study, assessed up to 15 days|the level of blood 8-hydroxy-2-deoxyguanosine(8-OHdG), changes of the level of blood 8-OHdG substance before and after the intervention, From date of randomization until the end of study, assessed up to 15 days | Other: the incidence of hypoglycemia, the incidence of hypoglycemia, defined as blood glucose lower than 3.9mmol/L, From date of randomization until the end of study, assessed up to 15 days|the incidence of severe hypoglycemia, defined as hypoglycemia which need other people's help or blood glucose lower than 2.8mmol/L, From date of randomization until the end of study, assessed up to 15 days
Sponsor/Collaborators: Sponsor: Third Affiliated Hospital, Sun Yat-Sen University | Collaborators: Guangdong Provincial Department of Science and Technology
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 70
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-07
Completion Date: 2016-09
Results First Posted:
Last Update Posted: 2015-08-20
Locations: Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University, Guangzhou City, Guangdong, 510630, China
URL: https://clinicaltrials.gov/show/NCT02526810