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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg); Drug: DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg); Drug: DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg); Drug: Placebo matching DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg)

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.

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • First Hospital of Peking Unversity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 50mg group; Participants received one 50mg of DBPR108 tablet and two placebos matching DBPR108 100mg under fasted conditions for one day.	Drug: DBPR108 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
EXPERIMENTAL: 100mg group; Participants received one 100mg of DBPR108 tablet and two placebos matching DBPR108 50mg and 100mg under fasted conditions for one day.	Drug: DBPR108 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
EXPERIMENTAL: 200mg group; Participants received two 100mg of DBPR108 tablets and one placebo matching DBPR108 50mg under fasted conditions for one day.	Drug: DBPR108 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
PLACEBO_COMPARATOR: placebo group; Participants received two placebo matching DBPR108 100mg and one placebo matching DBPR108 50mg	Drug: Placebo 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBA1c	Changes in HbA1c compared to baseline at week 12	Baseline, week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBA1c	Changes in HbA1c compared to baseline at week 8, week 4	Baseline, week 8, week4
Fasting plasma glucose	Changes in Fasting plasma glucose compared to baseline at week 4,week 8, week 12	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	Baseline, week 4，week 8, week 12
fasting glucagon	Changes in fasting glucagon compared to baseline at week 4,week 8, week 12	Baseline, week 4，week 8, week 12
fasting Insulin	Changes in fasting Insulin compared to baseline at week 4,week 8, week 12	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	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	week 12
body weight	Changes in body weight（Kg）compared to baseline at week 4,week 8, week 12	Baseline, week 4，week 8, week 12

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2017
• Primary Completion (ACTUAL): February 27, 2019
• Study Completion (ACTUAL): June 28, 2019

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (ACTUAL): October 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: type 2 diabetes mellitus; DPP4 inhibitor; DBPR108
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CSPC/HA1117/PRO-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No