DBPR108 Tablets in Type 2 Diabetes Mellitus Patients
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of DBPR108 Tablets for Type 2 Diabetes Mellitus
1 other identifier
interventional
276
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes-mellitus
Started Oct 2017
Typical duration for phase_2 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2019
CompletedFirst Submitted
Initial submission to the registry
July 8, 2019
CompletedFirst Posted
Study publicly available on registry
October 11, 2019
CompletedOctober 15, 2019
July 1, 2019
1.4 years
July 8, 2019
October 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HBA1c
Changes in HbA1c compared to baseline at week 12
Baseline, week 12
Secondary Outcomes (8)
HBA1c
Baseline, week 8, week4
Fasting plasma glucose
Baseline, week 4，week 8, week 12
2-hour postprandial plasma glucose
Baseline, week 4，week 8, week 12
fasting glucagon
Baseline, week 4，week 8, week 12
fasting Insulin
Baseline, week 4，week 8, week 12
- +3 more secondary outcomes
Study Arms (4)
50mg group
EXPERIMENTALParticipants received one 50mg of DBPR108 tablet and two placebos matching DBPR108 100mg under fasted conditions for one day.
100mg group
EXPERIMENTALParticipants received one 100mg of DBPR108 tablet and two placebos matching DBPR108 50mg and 100mg under fasted conditions for one day.
200mg group
EXPERIMENTALParticipants received two 100mg of DBPR108 tablets and one placebo matching DBPR108 50mg under fasted conditions for one day.
placebo group
PLACEBO COMPARATORParticipants received two placebo matching DBPR108 100mg and one placebo matching DBPR108 50mg
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Subjects who meet the World Health Organization(WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes;
- ≤ age ≤ 75 years old, male or female;
- One of the following conditions:
- Initial diagnosis of type 2 diabetes mellitus;
- 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);
- kg/m\^2 ≤ Body Mass Index（BMI ）≤ 35kg/m\^2;
- % ≤ 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;
You may not qualify if:
- 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;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Hospital of Peking Unversity
Beijing, Beijing Municipality, China
Related Publications (1)
Wang W, Yao J, Guo X, Guo Y, Yan C, Liu K, Zhang Y, Wang X, Li H, Wen Z, Wang X, Li S, Xiao X, Liu W, Li Z, Zhang L, Shao S, Ye S, Qin G, Li Y, Li F, Zhang X, Li X, Peng Y, Deng H, Xu X, Zhou L, Huang Y, Cao M, Xia X, Shi M, Dou J, Yuan J. Efficacy and safety of DBPR108 monotherapy in patients with type 2 diabetes: a 12-week, randomized, double-blind, placebo-controlled, phase II clinical trial. Curr Med Res Opin. 2020 Jul;36(7):1107-1115. doi: 10.1080/03007995.2020.1761311. Epub 2020 May 12.
PMID: 32338063DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2019
First Posted
October 11, 2019
Study Start
October 17, 2017
Primary Completion
February 27, 2019
Study Completion
June 28, 2019
Last Updated
October 15, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share