Clinical Study of Retagliptin Phosphate Combined With Metformin in the Treatment of Type 2 Diabetes

NCT05054842 | Unknown Phase 3

• 1 other identifier: HR-SP2086-304
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

Retagliptin phosphate tablet is a DPP IV inhibitor durg，study number is HR-SP2086-304. The primary purpose of the study is to evaluate the efficacy of the combination of Retagliptin phosphate and metformin compared with placebo and metformin in type 2 diabetes subjects with poor glycemic control treated with metformin for 16 weeks.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Changes in HbA1c relative to baseline

  After 16 weeks of treatment

Secondary Outcomes (9)

• The proportion of subjects with HbA1c<6.5% and HbA1c< 7% after 16 weeks of treatment

  up to 16 weeks of treatment

• Changes in fasting plasma glucose relative to baseline

  up to 16 weeks of treatment

• Changes in 2h postprandial blood glucose relative to baseline

  up to 16 weeks of treatment

• Changes in body weight relative to baseline

  up to 16 weeks of treatment

• Percentage of subjects in each group who received remedial treatment

  up to 16 weeks of treatment]

Study Arms (2)

treatment group A

EXPERIMENTAL

Drug: Retagliptin phosphate tablets、metformin sustained-release tablets

treatment group B

PLACEBO COMPARATOR

Drug: Retagliptin phosphate placebo tablets、metformin sustained-release tablets

Interventions

Retagliptin phosphate tablets、metformin sustained-release tablets DRUG

Retagliptin phosphate tablets 100mg+ metformin sustained-release tablets 1500mg or 2000mg based on prior medication

treatment group A

Retagliptin phosphate placebo tablets、metformin sustained-release tablets DRUG

Retagliptin phosphate 100mg placebo tablets + metformin sustained-release tablets 1500mg or 2000mg based on prior medication

treatment group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed the informed consent, understood the procedures and methods of the study, and was willing to complete the study strictly in accordance with the clinical trial protocol;
• The screening age should be 18-75 years old (including both ends), male or female;
• Diagnosed with type 2 diabetes, 7.5%≤HbA1c≤11%;
• At least 8 weeks prior to screening, in addition to regular diet control and exercise, a steady dose of metformin ≥1500mg/d;
• Fasting glucose ≤13.3mmol/L; 6、19.0 \< BMI 35.0 kg/m2 or less.

You may not qualify if:

• General situation:
• \) Known or suspected allergy to DPP4i drugs or investigational drug excipients;
• \) Pregnant or lactating women, fertile men or women were unwilling to use contraception during the study period;
• History or evidence of any of the following diseases at the time of screening:
• \) Type 1 diabetes, single-gene mutation diabetes, diabetes due to pancreatic damage, or other secondary diabetes (e.g., diabetes due to Cushing's syndrome or acromegaly);
• \) Acute metabolic complications (such as ketoacidosis, lactic acidosis or hypertonic coma) occurred within 6 months prior to screening; Or have serious chronic complications of diabetes in the past (such as severe macrovascular or microvascular complications as judged by the investigator) and the investigator considers that they are not suitable to participate in this study;
• \) There is a history of severe hypoglycemia (such as drowsiness, disturbance of consciousness, delirium, or even coma caused by hypoglycemia, which requires the assistance of others for treatment), or repeated hypoglycemia (≥3 symptomatic hypoglycemia within a week, or blood glucose \<3.0 mmol/L detected at least 3 times within a week);
• \) Patients with poorly controlled hypertension at screening were defined as systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg;
• \) Had myocardial infarction, unstable angina, stroke (except lacunar infarction without attack symptoms) or transient ischemic attack, or had undergone coronary angioplasty, percutaneous coronary stent implantation or coronary artery bypass grafting within 6 months prior to screening; Or had congestive heart failure (NYHA grades III and IV), unstable or acute congestive heart failure, or persistent arrhythmias that the investigator determined significantly affected the subjects' safety within the 6 months prior to screening;
• \) History of acute and chronic pancreatitis, or risk factors that may lead to pancreatitis, such as history of symptomatic gallbladder, history of pancreatic injury, etc. (except cholecystectomy);
• \) A history of malignant tumor within 5 years prior to screening, excluding treated local basal cell carcinoma of the skin;
• \) have obvious diseases of the blood system (such as aplastic anemia, myelodysplastic syndrome, hemolytic anemia) or any diseases causing hemolysis or red blood cell instability (such as malaria);
• \) Clinically significant gastric emptying abnormalities (e.g., gastric outlet obstruction), severe chronic gastrointestinal diseases (e.g., active ulcers within 6 months prior to screening);
• \) There is a history of drug or alcohol abuse within 3 months prior to screening, which may affect the subject's compliance to participate in the test according to the investigator's judgment;
• Received any of the following pharmacological or non-pharmacological treatments or procedures prior to screening:

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SP2086 VS. Placebo

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 23, 2021
• Study Start: December 6, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-06

Locations

CN (1)