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Clinical Trial Details

Trial ID: L2650
Source ID: NCT04014192
Associated Drug: Dapagliflozin
Title: Effects of SGLT2 Inhibitors on Islet Cell Function and Insulin Sensitivity in Patients of Type 2 Diabetes Mellitus
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Dapagliflozin|DRUG: Empagliflozin|DRUG: Canagliflozin
Outcome Measures: Primary: Change from baseline to post-treatment in insulin sensitivity., Insulin sensitivity is calculated by the following formula according to blood glucose and insulin levels in OGTT (Oral Glucose Tolerance Test). 1.1 OGTT Matsuda and De Fronzo Insulin Sensitivity Index(ISOGTT):10000/square root(Gluc0×Ins0×mean Gluc×mean Ins)。Mean gluc and mean Ins are average values calculated by each value in 0, 60, 120 and 180 minutes of OGTT. 1.2 QUICKI(quantitative insulin sensitivity check index)model:1/(log\[Ins0\]+ log\[Gluc0\]) 1.3 HOMA-IR:(Gluc0×Ins0)/22.5, Baseline, Week 1(extended to Week 2 if without significantly decrease in blood glucose)|Change from baseline to post-treatment in islet beta cell secretory function., Islet beta cell secretory function is calculated by area under the curve of blood glucose、 insulin、C-peptide in OGTT and following formula above. 2.1 Stumvoll first phase insulin secretion:1,194+4.724×Ins0-117.0 ×Gluc60 + 1.414×Ins60 2.2 Stumvoll second phase insulin secretion:295+0.349×Ins60-25.72×Gluc60+1.107×Ins0 2.3 HOMA-β:(20×Ins0)/(Gluc0-3.5), Baseline, Week 1(extended to Week 2 if without significantly decrease in blood glucose)|Change from baseline to post-treatment in islet alpha cell secretory function., Islet Alpha Cell secretory function is calculated by area under the curve of blood glucose、glucagon level in OGTT., Baseline, Week 1(extended to Week 2 if without significantly decrease in blood glucose) | Secondary: Change from baseline to post-treatment in weight., Baseline, Week 1(extended to Week 2 if without significantly decrease in blood glucose)|Change from baseline to post-treatment in fasting blood glucose and non-fasting blood glucose., Baseline, Week 1(extended to Week 2 if without significantly decrease in blood glucose)|Change from baseline to post-treatment in fasting insulin level., Baseline, Week 1(extended to Week 2 if without significantly decrease in blood glucose)|Change from baseline to post-treatment in blood lipid including cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol., Baseline, Week 1(extended to Week 2 if without significantly decrease in blood glucose)|Change from baseline to post-treatment in urine volume and urine glucose level., Baseline, Week 1(extended to Week 2 if without significantly decrease in blood glucose)|Change from baseline to post-treatment in urinary output of uric acid, sodium, calcium, and phosphorus., Baseline, Week 1(extended to Week 2 if without significantly decrease in blood glucose)
Sponsor/Collaborators: Sponsor: Peking Union Medical College Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-09-01
Completion Date: 2020-07-31
Results First Posted:
Last Update Posted: 2019-09-24
Locations: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China
URL: https://clinicaltrials.gov/show/NCT04014192