Evaluation of Efficacy and Safety of Combination Therapy of Henagliflozin Proline, Retagliptin and Metformin in New Diagnosed Type 2 Diabetes Patients

NCT06417489 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2024-165-002
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluated the efficacy and safety of initial combined treatment of Henggliptin, Retagliptin and Metformin by including new type 2 diabetes patients. This study is a multicenter, randomized, open label, positive control study. It is planned to include 160 new type 2 diabetes patients who meet the inclusion criteria of the study. The study is divided into three stages: screening period (V0, -14d-0), treatment period (V1-V8, D1-24w) and safe follow-up period (V9, 28w), with a total of 10 planned visits. This study was divided into an experimental group and a control group. The experimental group received a one-time addition of 10 mg qd of Henggliptin, 100 mg qd of Regagliptin, and 500mg of Metformin. The control group was first treated with metformin. If the blood sugar level did not meet the standard (fasting blood glucose (FPG)\>7mmol/L, postprandial blood glucose (PPG)\>10mmol/L), Henggeliflozin 10 mg qd was sequentially added. If the blood sugar level did not meet the standard after 4 weeks, Regagliptin 100 mg qd was added. During the follow-up period, evaluate blood glucose control, pancreatic islet function, and safety in both groups of patients.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with HbA1c<7% at 12w

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (15)

• The proportion of subjects with HbA1c<7% at week 24

  From enrollment to the end of treatment at 24 weeks

• The proportion of subjects with HbA1c<6.5% at 12 week

  From enrollment to the end of treatment at 12 weeks

• The proportion of subjects with HbA1c<6.5% at 24 week

  From enrollment to the end of treatment at 24 weeks

• Changes in HbA1c compared to baseline at 12 weeks

  From enrollment to the end of treatment at 12 weeks

• Changes in HbA1c compared to baseline at 24 weeks

  From enrollment to the end of treatment at 24 weeks

Study Arms (2)

Combination therapy

EXPERIMENTAL

Henagliflozin Proline 10 mg qd+Regagliptin 100 mg qd+Metformin 500mg bid. The dose of metformin from the first to second week is 500mg bid, and the dose from the third to fourth week is 1000mg bid. If the maximum dose of metformin cannot be tolerated, the researcher shall increase the dosage according to the patient's tolerance situation. The minimum dose is 1000mg/day.

Drug: Combination therapy

Sequential treatment group

ACTIVE COMPARATOR

Metformin, the dose from the first to second week is 500mg bid, and the dose from the third to fourth week is 1000mg bid. If the maximum dose of metformin cannot be tolerated, the researcher shall increase the dosage according to the patient's tolerance situation. The minimum dose is 1000mg/day. After the fourth week of treatment, blood glucose levels were measured. For those whose blood glucose levels did not meet the standard (fasting blood glucose (FPG)\>7mmol/L, postprandial blood glucose (PPG)\>10mmol/L), 10 mg qd of Henagliflozin Proline was sequentially added. If the blood glucose levels did not meet the standard after 4 weeks of treatment (FPG\>7mmol/L, PPG\>10mmol/L), 100 mg qd of Ruigeliflozin was added

Drug: Sequential treatment group

Interventions

Combination therapy DRUG

Henagliflozin Proline 10 mg qd+Regagliptin 100 mg qd+Metformin 500mg bid. The dose of metformin from the first to second week is 500mg bid, and the dose from the third to fourth week is 1000mg bid. If the maximum dose of metformin cannot be tolerated, the researcher shall increase the dosage according to the patient\&#39;s tolerance situation. The minimum dose is 1000mg/day.

Combination therapy

Sequential treatment group DRUG

Metformin, the dose from the first to second week is 500mg bid, and the dose from the third to fourth week is 1000mg bid. If the maximum dose of metformin cannot be tolerated, the researcher shall increase the dosage according to the patient\&#39;s tolerance situation. The minimum dose is 1000mg/day. After the fourth week of treatment, blood glucose levels were measured. For those whose blood glucose levels did not meet the standard (fasting blood glucose (FPG)\&gt;7mmol/L, postprandial blood glucose (PPG)\&gt;10mmol/L), 10 mg qd of Henagliflozin Prolinewas sequentially added. If the blood glucose levels did not meet the standard after 4 weeks of treatment (FPG\&gt;7mmol/L, PPG\&gt;10mmol/L), 100 mg qd of Ruigeliflozin was added

Sequential treatment group

Eligibility Criteria

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

You may qualify if:

• Untreated newly diagnosed T2DM patients;
• Age ≥ 18 years old;
• % ≤ HbA1c\&lt;11.0%;
• kg/m2 ≤ BMI\&lt;35 kg/m2;
• eGFR ≥ 60 ml/min1.73m2;
• Voluntarily participate and sign an informed consent form

You may not qualify if:

• Pregnant and lactating women, as well as women of childbearing age who are unwilling to take reliable contraceptive measures;
• Individuals who are known to be allergic to Henggliflozin, Regagliptin, or Metformin;
• Other types of diabetes except type 2 diabetes;
• Type 2 diabetes with a history of ketoacidosis (DKA) in the last 6 months;
• NYHA cardiac grade IV patients;
• Within 30 days prior to the screening visit, admission due to acute coronary syndrome (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery; Or plan to undergo percutaneous coronary intervention or cardiac surgery within 3 months.
• Confirmed respiratory system diseases (such as chronic obstructive pulmonary disease, pulmonary arterial hypertension, etc.);
• History of acute or chronic pancreatitis;
• Uncontrolled hypertension, defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg (average of three supine blood pressure measurements) during screening visits;
• Patients with orthostatic hypotension and/or systolic blood pressure\&lt;90 mmHg at visit 0 or visit 1, or clinically diagnosed as having low blood volume;
• Diagnosed malignant tumor patients with an expected life expectancy of less than 1 year;
• Patients with a history of recurrent urinary and reproductive tract infections (judged by clinical doctors);
• Patients who participate in other clinical trials within 3 months;
• Alcohol or drug addiction.
• In addition to the above, the researchers determined that patients who are not suitable to participate in this clinical trial.

Sponsors & Collaborators

• Peking University First Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Junqing Zhang

CONTACT

8613611167278; nan.gu@pkufh.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 16, 2024
• Study Start: May 31, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05