NCT06417489Not yet recruitingPhase 4
Evaluation of Efficacy and Safety of Combination Therapy of Henagliflozin Proline, Retagliptin and Metformin in New Diagnosed Type 2 Diabetes Patients
Evaluation of Efficacy and Safety of Combination Therapy of Henagliflozin Proline, Retagliptin and Metformin Compared to Sequential Metformin Therapy in Newly Diagnosed Type 2 Diabetes Patients
Source: ClinicalTrials.gov · Last updated 16 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 11 May 2024
- Start date
- 31 May 2024
- Primary completion date
- 30 May 2026
- Lead sponsor
- Peking University First Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT06417489
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 160
- From 31 May 2024 to the primary completion date, 30 May 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Alcohol or drug addiction.
Other illness
- 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;
- 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;
- 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);
Age
- Pregnant and lactating women, as well as women of childbearing age who are unwilling to take reliable contraceptive measures;
Other
- Patients with orthostatic hypotension and/or systolic blood pressure\<90 mmHg at visit 0 or visit 1, or clinically diagnosed as having low blood volume;
- Patients who participate in other clinical trials within 3 months;
- In addition to the above, the researchers determined that patients who are not suitable to participate in this clinical trial.
Who the study is looking for
- Untreated newly diagnosed T2DM patients;
- Age ≥ 18 years old;
- 8.0% ≤ HbA1c\<11.0%;
- 19 kg/m2 ≤ BMI\<35 kg/m2;
- eGFR ≥ 60 ml/min1.73m2;
- Voluntarily participate and sign an informed consent form
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.