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Completed

NCT Number: NCT04161430

A Study to Evaluate the Efficacy and Safety of DBPR108 100 mg in Type 2 Diabetes Mellitus Patients

This study will evaluate the efficacy and safety of 100 mg DRBP108 tablets in the treatment of type 2 diabetes mellitus. A total of 750 subjects will be randomly allocated to three groups: DRBP108, active comparator and placebo comparator, in a 3:1:1 ratio. The purpose of this study is to evaluate whether 24 weeks of DRBP108 treatment will adequately reduce hemoglobin A1C levels in T2DM subjects.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University First Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 19kg/m^2 ≤ Body Mass Index（BMI ）≤ 35kg/m^2;
  • Subjects with type 2 diabetes mellitus who did not regularly take oral hypoglycemic drugs at least 8 weeks before screening (i.e., continuous medication for <1 week);
  • 7.0% ≤ HbA1c ≤ 9.5%;
  • Subjects voluntarily participate in the trial and sign the informed consent form;
  • Subjects agree to use contraception from the signing of the informed consent form to the end of 1 month of the last medication.

Exclusion criteria

  • FPG > 13.9 mmol/L;
  • A history of severe hypoglycemia (that is, hypoglycemia with severe cognitive impairment and requiring other measures to help recover);
  • A history of allergy to similar drugs (DPP-4 inhibitors) or those who have been judged by the investigator to be allergic to tested drugs;
  • Uncured hyperthyroidism or other diseases may cause secondary blood sugar elevation;
  • Continuous use of glucocorticoids within 4 weeks prior to screening or may uninterrupted use glucocorticoids ≥14 days during the trial (except for external use and inhalation)
  • Subjects with chronic bowel disease associated with inflammatory bowel disease, partial intestinal obstruction, or obvious digestive and absorption disorders;
  • Subjects with infectious diseases(all positive for HBsAg, HBeAg, HBcAb, or positive for hepatitis C antibody, or positive for anti-HIV antibody); Female subjects of childbearing age are positive in pregnancy test or are lactating;
  • Subjects with a history of alcoholism or drug abuse;
  • Subjects have the clinically significant unstable diseases;
  • Not suitable for this clinical trial judged by the investigator.

Treatment and study plan

DBPR108; Placebo matching sitagliptin

Drug

Phase A (Weeks 1-24): DBPR108 100 mg once daily under fasted conditions for 24 weeks; Placebo matching sitagliptin 100 mg once daily under fasted conditions for 24 weeks.

Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks.

Placebo matching DBPR108; Sitagliptin; DBPR108

Drug

Phase A (Weeks 1-24): Placebo matching DBPR108 100mg once daily under fasted conditions for 24 weeks; Sitagliptin 100 mg once daily under fasted conditions for 24 weeks.

Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks.

Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108

Drug

Phase A (Weeks 1-24): Placebo matching DBPR108 100 mg once daily under fasted conditions for 24 weeks; Placebo matching sitagliptin 100 mg once daily under fasted conditions for 24 weeks.

Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks.

Primary outcomes

  1. Change from baseline in HbA1c (%) compared to placebo comparator at week 24

    Time frame: Baseline, week 24

    Change reflects the experimental value (baseline subtract) minus the placebo comparator value (baseline subtract) at week 24. HbA1c represents the percentage of glycosylated hemoglobin.

Secondary outcomes

  1. Change from baseline in HbA1c (%) compared to active comparator at week 24

    Time frame: Baseline, week 24

    Change reflects the experimental value (baseline subtract) minus the active comparator value (baseline subtract) at week 24. HbA1c represents the percentage of glycosylated hemoglobin.

  2. The percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 24

    Time frame: Week 24

    Clinical response will be assessed by the percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 24.

  3. Change from baseline in HbA1c (%) at week 12, week 40, week 52

    Time frame: Baseline, week 12, week 40, week 52

    Change reflects the experimental value minus the baseline value at week 12, week 40, week 52. HbA1c represents the percentage of glycosylated hemoglobin.

  4. The percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 12, week 40, week 52

    Time frame: Week 12, week 40, week 52

    Clinical response will be assessed by the percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 12, week 40, week 52.

  5. Change from baseline in fasting plasma glucose/2-hour postprandial plasma glucose/body weight at week 12,week 24

    Time frame: Baseline, week 12, week 24

    Change reflects the experimental value minus the baseline value in the fasting plasma glucose/2-hour postprandial plasma glucose/body weight at week 12,week 24. Plasma glucose was measured on a fasting basis or 2 hours after a standard meal, and is expressed as mmol/L. Body weight is expressed as kg.

Sponsors and collaborators

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Industry

Registry information

Official study title

A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Comparator, Placebo-Controlled Clinical Trial of DBPR108 Tablets for Type 2 Diabetes Mellitus

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 13, 2019
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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