This study evaluate DRBP108 in the treatment of type 2 diabetes mellitus. The patients were randomly allocated to four groups: 50 mg, 100 mg, 200 mg and placebo group.
This study was to evaluate DRBP108 in the treatment of type 2 diabetes mellitus. A total of 268 subjects were randomly allocated to four treatment arms: 50 mg, 100 mg, 200 mg or placebo group, in a 1:1:1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
276
One DBPR108 tablet(50mg) administered orally once a day + Two Placebos matching DBPR108 tablet(100mg) administered orally once a day for 12 weeks
One DBPR108 tablet(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks
First Hospital of Peking Unversity
Beijing, Beijing Municipality, China
HBA1c
Changes in HbA1c compared to baseline at week 12
Time frame: Baseline, week 12
HBA1c
Changes in HbA1c compared to baseline at week 8, week 4
Time frame: Baseline, week 8, week4
Fasting plasma glucose
Changes in Fasting plasma glucose compared to baseline at week 4,week 8, week 12
Time frame: Baseline, week 4,week 8, week 12
2-hour postprandial plasma glucose
Changes in 2-hour postprandial plasma glucose compared to baseline at week 4,week 8, week 12
Time frame: Baseline, week 4,week 8, week 12
fasting glucagon
Changes in fasting glucagon compared to baseline at week 4,week 8, week 12
Time frame: Baseline, week 4,week 8, week 12
fasting Insulin
Changes in fasting Insulin compared to baseline at week 4,week 8, week 12
Time frame: Baseline, week 4,week 8, week 12
active Glucagon-like peptide-1(GLP-1)
Changes in active(GLP-1)compared to baseline at week 4,week 8, week 12
Time frame: Baseline, week 4,week 8, week 12
The percentage of HbA1c≤6.5% or HbA1c≤7%
The percentage of HbA1c≤6.5% or HbA1c≤7% at week 12
Time frame: week 12
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Two DBPR108 tablets(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks
Two Placebos matching DBPR108 tablet(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks
body weight
Changes in body weight(Kg)compared to baseline at week 4,week 8, week 12
Time frame: Baseline, week 4,week 8, week 12