The purpose of the trial is to verify the effectiveness and safety of glimepiride compared with sitagliptin as an add-on therapy to metformin in severe insulin deficiency diabetes.
This clinical trial is a multi-centre, prospective, intervention, randomized-controlled clinical trial, and uses a superiority test to determine whether the experimental group is superior to the control group in terms of main efficacy endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
Initiate glimepiride 1-4mg once daily as an add-on therapy to metformin and adjust the glimepiride dosage to 1-6 mg once daily in the first 12 weeks according to the diabetes management guideline recommended by the Chinese Diabetes Society.
Add sitagliptin 100mg once daily in all patients randomized to this arm.
Peking University People's Hospital
Beijing, Please Select, China
RECRUITINGReduction of hemoglobin A1c from baseline at the end of the trial.
The Least squre mean of the decline of hemoglobin A1c from baseline to the end of the trial
Time frame: 26 weeks
Hemoglobin A1c on-target rate
the percentage of A1c\<7.0% or A1c\<6.5%
Time frame: 26 weeks
The difference of self measure blood glucose (SMBG) at every month
The mean of 4-point SMBG for every four weeks
Time frame: for 26 weeks
The incidence rate of hypoglycemia
Any measurement of blood glucose\<3.9mmol/L or symptoms related to hypoglycemia
Time frame: for 26 weeks
The level of weight gain
The difference between body weights at the beginning and end of the trial
Time frame: for 26 weeks
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