Impact of Short-term Intensive De-escalation Therapy on Long-term Regimen Simplification (NCT03958591) | Clinical Trial Compass
CompletedPhase 4
Impact of Short-term Intensive De-escalation Therapy on Long-term Regimen Simplification
China274 participantsStarted 2019-05-01
Plain-language summary
Despite advances in diabetes management, many patients with type 2 diabetes in China fail to achieve optimal glycemic control. One of the possible reasons is associated with the delay in therapeutic decision making that lags behind glycemic rise. The investigators design this study and presume that using vildagliptin and metformin in combination with basal insulin as sequential treatment after intensive insulin therapy, might better modulate the dual islet hormone dysfunction than traditionally stepwise upgrading therapy pattern in patients with poorly controlled T2DM, and thus lead to a glucose normalization, β-cell function improvement and therapy simplification.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
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Inclusion criteria
. Type 2 diabetes diagnosed according to WHO criteria (1999); With a duration of 1\~15 years;
. With two or more oral hypoglycemic drugs, or basal insulin and 1-2 oral hypglycemic agents, used for at least 3 months;
. HbA1c of 7.5 to 13% and fasting C-peptide \> 0.4 nmol/L;
. Age of 18 to 70 years;
. BMI of 20 to 35 kg/m²；
. Capable of and willing to follow doctors' instructions to:
. Those who have received premixed insulin therapy and/or basal - meal insulin and/or basal insulin-oral hypoglycemic agents treatment accumulation for 7 days or more, and those who have received CSII therapy in the last one year, and those who have received GLP-1 analogue within 3 months before screening;
. Those who have acute diabetic complications (diabetic ketoacidosis, hyperosmotic hyperglycemia coma or lactic acidosis);
. Those who have severe diabetic microvascular complications (proliferative retinopathy, clinical proteinuria, and glomerular filtration rate less than 45 ml/min, uncontrolled diabetic neuropathy and obvious diabetic autonomic neuropathy);
. Those with ALT \>2.5 times of the upper limit of normal (ULN), bilirubin \> 1.5 times of ULN；
. Those with known macrovascular disease: Patients with acute cerebrovascular accident, acute coronary syndrome, unstable angina, peripheral artery disease who have received vascular intervention or amputation in the 12 months before enrollment; Or chronic cardiac dysfunction with cardiac function grade III or above;
. Those with poor blood pressure control (systolic blood pressure≥160mmHg and/or sitting diastolic blood pressure ≥110mmHg) and inability to control under 160/110mmhg within 1 week;
. Serious systemic disease or malignant tumor, chronic diarrhea, etc；