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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: DBPR108; Placebo matching sitagliptin
* Drug: Placebo matching DBPR108; Sitagliptin; DBPR108
* Drug: Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DRBP108<br>Phase A (Weeks 1-24): DBPR108 100mg + placebo matching Sitagliptin 100 mg; Phase B (Weeks 25-52): DBPR108 100 mg | Drug: DBPR108; Placebo matching sitagliptin<br>* 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.<br>|
| Active Comparator: Sitagliptin<br>Phase A (Weeks 1-24): Placebo matching DBPR108 100 mg + Sitagliptin 100 mg; Phase B (Weeks 25-52): DBPR108 100 mg | Drug: Placebo matching DBPR108; Sitagliptin; DBPR108<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Phase A (Weeks 1-24): Placebo matching DBPR108 100 mg + placebo matching Sitagliptin 100 mg; Phase B (Weeks 25-52): DBPR108 100 mg | Drug: Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c (%) compared to placebo comparator at 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. | Baseline, week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c (%) compared to active comparator at 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. | Baseline, week 24 | 
| The percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 24 | Clinical response will be assessed by the percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 24. | Week 24 | 
| Change from baseline in HbA1c (%) at 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. | Baseline, week 12, week 40, week 52 | 
| The percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at 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. | Week 12, week 40, week 52 | 
| Change from baseline in fasting plasma glucose/2-hour postprandial plasma glucose/body weight at 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. | Baseline, week 12, week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DBPR108, Type 2 diabetes mellitus, DPP4 inhibitor