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DBPR108 Tablets in Type 2 Diabetes Mellitus Patients

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ClinicalTrials.gov Identifier: NCT04124484
Recruitment Status : Completed
First Posted : October 11, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus 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) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of DBPR108 Tablets for Type 2 Diabetes Mellitus
Actual Study Start Date : October 17, 2017
Actual Primary Completion Date : February 27, 2019
Actual Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. HBA1c [ Time Frame: Baseline, week 12 ]
    Changes in HbA1c compared to baseline at week 12


Secondary Outcome Measures :
  1. HBA1c [ Time Frame: Baseline, week 8, week4 ]
    Changes in HbA1c compared to baseline at week 8, week 4

  2. Fasting plasma glucose [ Time Frame: Baseline, week 4,week 8, week 12 ]
    Changes in Fasting plasma glucose compared to baseline at week 4,week 8, week 12

  3. 2-hour postprandial plasma glucose [ Time Frame: Baseline, week 4,week 8, week 12 ]
    Changes in 2-hour postprandial plasma glucose compared to baseline at week 4,week 8, week 12

  4. fasting glucagon [ Time Frame: Baseline, week 4,week 8, week 12 ]
    Changes in fasting glucagon compared to baseline at week 4,week 8, week 12

  5. fasting Insulin [ Time Frame: Baseline, week 4,week 8, week 12 ]
    Changes in fasting Insulin compared to baseline at week 4,week 8, week 12

  6. active Glucagon-like peptide-1(GLP-1) [ Time Frame: Baseline, week 4,week 8, week 12 ]
    Changes in active(GLP-1)compared to baseline at week 4,week 8, week 12

  7. The percentage of HbA1c≤6.5% or HbA1c≤7% [ Time Frame: week 12 ]
    The percentage of HbA1c≤6.5% or HbA1c≤7% at week 12

  8. body weight [ Time Frame: Baseline, week 4,week 8, week 12 ]
    Changes in body weight(Kg)compared to baseline at week 4,week 8, week 12



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124484


Locations
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China, Beijing
First Hospital of Peking Unversity
Beijing, Beijing, China
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04124484     History of Changes
Other Study ID Numbers: CSPC/HA1117/PRO-II
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.:
DBPR108
type 2 diabetes mellitus
DPP4 inhibitor
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases