A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Parallel Controlled Phase III Clinical Trial of DBRP108 in Combination With Metformin Hydrochloride in the Treatment of Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04218734
• Other study ID #: CSPC/DBPR108201903/PRO-III-2
• Status: Completed
• Phase: Phase 3
• Start date: January 14, 2020
• Est. completion date: June 3, 2021

Study information

• Verified date: March 2021
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the efficacy and safety of DBPR108 tablets in combination with metformin hydrochloride in the treatment of type 2 diabetes mellitus. A total of 210 subjects will be randomly assigned in a ratio of 2:1 to receive metformin hydrochloride plus DBPR108 or metformin hydrochloride plus placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: June 3, 2021
• Est. primary completion date: June 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of type 2 diabetes according to World Health Organization (1999) diabetes diagnosis standard;

• Age 18-75 years, men and women;

• BMI 19-35 kg/m2;

• HbA1c 7.0%-9.5%;

• Before screening, a stable Metformin dose(=1000mg/day)should be maintained for at least 8 weeks.

• Signed informed consent from the patient;

• Agree to use contraceptive measures from the date of signing the informed consent to 1 month after the end of the last medication.

Exclusion Criteria:

• FPG > 13.9 mmol/L;

• Insulin treatment required in the investigator's opinion;

• Administration of antidiabetic drugs (except for metformin) including insulin, rosiglitazone, pioglitazone, DPP-4 inhibitor, Glucagon like peptide-1 (GLP-1) receptor agonist for 8 weeks before screening;

• Acute complications of diabetes (including diabetic ketosis and ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemia coma);

• Severe hypoglycemia;

• Serious diabetic complications (such as diabetic foot, etc.);

• History of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.);

• History of being allergic to DPP-4 inhibitors;

• Untreated hyperthyroidism and other diseases which may cause secondary hyperglycemia;

• Previous treatment with glucocorticoids (except for external use and inhalation) within 4 weeks before screening or may be used for more than 14 consecutive days during the study;

• Inflammatory bowel disease, partial intestinal obstruction or chronic bowel disease related to obvious digestive and absorption disorders;

• Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 3*upper limit of normal (ULN), or total bilirubin > 1.5ULN;

• Abnormal renal function;

• White blood cells (WBC) < 3.0109/l, neutrophil count of peripheral blood < 1.5109/l, hemoglobin < 100g / L, triglyceride > 5.7 mmol/l;

• HBsAg, HBeAg or HBcAb positive, or any one of hepatitis C antibody, anti-HIV antibody and nonspecific antibody of Treponema pallidum positive;

• Pregnant or lactating women;

• History of alcohol or drug abuse;

• Participation in other clinical trials or administration of any other investigational drugs or devices within 3 months before screening;

• Significant unstable diseases;

• Any condition that in the investigator's opinion might render the patient unable to participate the trial.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• DBPR108
DBPR108: 100 mg, once daily for 24 weeks.
• metformin hydrochloride
metformin hydrochloride: 500 mg, 1-3 times daily for 24 weeks.
• placepo
placebo:100 mg, once daily for 24 weeks.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (%) from baseline to week 24	The change of HbA1c from baseline to 24 weeks compared with metformin hydrochloride + placebo	baseline, 24 weeks
Secondary	Percentage of HbA1c = 6.5%	Proportion of patients achieving HbA1c = 6.5% at week 24	24 weeks
Secondary	Percentage of HbA1c = 7%	Proportion of patients achieving HbA1c = 7% at week 24	24 weeks
Secondary	Change in HbA1c (%) from baseline to week 12	The change of HbA1c from baseline to 12 weeks compared with metformin hydrochloride + placebo	baseline, 12 weeks
Secondary	Change in fasting plasma glucose (FPG) from baseline to week 12 and week 24	The change in FPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo	Baseline, 12 weeks and 24 weeks
Secondary	Change in 2h-postprandial plasma glucose (2h-PPG) from baseline to week 12 and week 24	The change in 2h-PPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo	Baseline, 12 weeks and 24 weeks
Secondary	Change in body weight from baseline to week 12 and week 24	The change in body weight from baseline to week 12 and week 24 compared with metformin hydrochloride +placebo	Baseline, 12 weeks and 24 weeks