Type 2 Diabetes Mellitus
Conditions
Keywords
DBPR108, type 2 diabetes mellitus, DPP4 inhibitor
Brief summary
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.
Detailed description
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.
Interventions
DRUGDBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg)
One DBPR108 tablet(50mg) administered orally once a day + Two Placebos matching DBPR108 tablet(100mg) administered orally once a day for 12 weeks
DRUGDBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg)
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
DRUGDBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg)
Two DBPR108 tablets(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks
DRUGPlacebo matching DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg)
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
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who meet the World Health Organization(WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes; * 18 ≤ age ≤ 75 years old, male or female; * One of the following conditions: 1. Initial diagnosis of type 2 diabetes mellitus; 2. Patients who with type 2 diabetes diagnosed within 2 years before screening period and are treated with single-agent oral hypoglycemic agents until screening, and do not take the medicine regularly for at least 8 weeks (i.e., continuous medication for \<1 week); * 19kg/m\^2 ≤ Body Mass Index（BMI ）≤ 35kg/m\^2; * 7.0% ≤ HbA1c ≤ 10.0%; * Female subjects of childbearing age are negative in pregnancy test; * All the subjects do not have a fertility plan during and three month after the trial; * Subjects who fully understand the test content and possible adverse reactions and voluntarily participate in the trial and sign the informed consent form;
Exclusion criteria
* FPG \> 15 mmol/L; * Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg during screening period; * Those who are known to be positive for HIV and syphilis; * known active hepatitis B virus infection, hepatitis C virus infection; * For patients with obvious liver diseases and chronic liver diseases, AST or ALT in screening stage was twice the normal upper limit. * In patients with renal insufficiency, serum creatinine at screening stage was 1.5 times higher than the upper limit of normal value; * Leukocyte and hemoglobin \< lower limit of normal value, triglyceride \> 5.7 mmol/L in screening stage; * With diabetic acute complications (including diabetic ketoacidosis, hypertonic non-ketoacid diabetic coma, lactic acidosis and hypoglycemic coma), chronic complications (proliferative diabetic retinopathy, diabetic nephropathy); * Use of insulin, pioglitazone, DPP-4 inhibitor, GLP-1 receptor agonist or any combination of two or more oral hypoglycemic drugs within 8 weeks before screening time. * Those who need insulin therapy; * Using and Used of glucocorticoids within 2 weeks before screening time. * without a pacemaker, the 12-lead ECG showed II or III degree atrioventricular block, long QT syndrome or corrected QT interval （QTc）\>500ms or atrial fibrillation during the screening period; * History of epilepsy, mental illness, major depression, or previous thyroid function abnormal and still being treated, or those with organ transplants, severe chronic lung disease, and other serious heart disease, cerebrovascular disease, blood disease; * Inflammatory bowel disease, colon ulcer, partial intestinal obstruction or chronic intestinal diseases associated with digestive and absorption diseases; * Active pancreatitis, cholecystitis, gallstones and other digestive diseases; * History of severe hypoglycemia; * History of allergies with similar drugs (DPP-4 inhibitors) or those who are judged by the investigator to be allergic to the test drug; * Pregnancy, lactating women; * Subjects who are participating in other clinical trials or who have participated in other drug trials within 3 months prior to screening; * Not suitable for this clinical trial judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HBA1c | Baseline, week 12 | Changes in HbA1c compared to baseline at week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting plasma glucose | Baseline, week 4，week 8, week 12 | Changes in Fasting plasma glucose compared to baseline at week 4,week 8, week 12 |
| 2-hour postprandial plasma glucose | Baseline, week 4，week 8, week 12 | Changes in 2-hour postprandial plasma glucose compared to baseline at week 4,week 8, week 12 |
| fasting glucagon | Baseline, week 4，week 8, week 12 | Changes in fasting glucagon compared to baseline at week 4,week 8, week 12 |
| HBA1c | Baseline, week 8, week4 | Changes in HbA1c compared to baseline at week 8, week 4 |
| active Glucagon-like peptide-1（GLP-1） | Baseline, week 4，week 8, week 12 | Changes in active（GLP-1）compared to baseline at week 4,week 8, week 12 |
| The percentage of HbA1c≤6.5% or HbA1c≤7% | week 12 | The percentage of HbA1c≤6.5% or HbA1c≤7% at week 12 |
| body weight | Baseline, week 4，week 8, week 12 | Changes in body weight（Kg）compared to baseline at week 4,week 8, week 12 |
| fasting Insulin | Baseline, week 4，week 8, week 12 | Changes in fasting Insulin compared to baseline at week 4,week 8, week 12 |
Countries
China
Outcome results
None listed