Clinical trial NCT06417489: Evaluation of Efficacy and Safety of Combination Therapy of Henagliflozin Proline, Retagliptin and Metformin in New Diagnosed Type 2 Diabetes Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)\&gt;7mmol/L, postprandial blood glucose (PPG)\&gt;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.


Eligibility criteria: Inclusion Criteria:

1. Untreated newly diagnosed T2DM patients;
2. Age ≥ 18 years old;
3. 8.0% ≤ HbA1c\&lt;11.0%;
4. 19 kg/m2 ≤ BMI\&lt;35 kg/m2;
5. eGFR ≥ 60 ml/min1.73m2;
6. Voluntarily participate and sign an informed consent form

Exclusion Criteria:

1. Pregnant and lactating women, as well as women of childbearing age who are unwilling to take reliable contraceptive measures;
2. Individuals who are known to be allergic to Henggliflozin, Regagliptin, or Metformin;
3. Other types of diabetes except type 2 diabetes;
4. Type 2 diabetes with a history of ketoacidosis (DKA) in the last 6 months;
5. NYHA cardiac grade IV patients;
6. 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.
7. Confirmed respiratory system diseases (such as chronic obstructive pulmonary disease, pulmonary arterial hypertension, etc.);
8. History of acute or chronic pancreatitis;
9. 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;
10. 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;
11. Diagnosed malignant tumor patients with an expected life expectancy of less than 1 year;
12. Patients with a history of recurrent urinary and reproductive tract infections (judged by clinical doctors);
13. Patients who participate in other clinical trials within 3 months;
14. Alcohol or drug addiction.
15. In addition to the above, the researchers determined that patients who are not suitable to participate in this clinical trial.

Primary outcomes:
measure: Proportion of subjects with HbA1c<7% at 12w
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: The proportion of subjects with HbA1c<7% at week 24
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: The proportion of subjects with HbA1c<6.5% at 12 week
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: The proportion of subjects with HbA1c<6.5% at 24 week
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Changes in HbA1c compared to baseline at 12 weeks
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Changes in HbA1c compared to baseline at 24 weeks
timeFrame: From enrollment to the end of treatment at 24 weeks
measure: Changes in fingertip blood glucose (seven point blood glucose spectrum) compared to baseline at 4w, 8w, 12w, and 24w
timeFrame: From enrollment to the end of treatment at 4/8/12/24 weeks
measure: Changes in 2hPPG compared to baseline at 4w, 8w, 12w, and 24w
timeFrame: From enrollment to the end of treatment at 4/8/12/24 weeks
measure: Changes in FBG compared to baseline at 4w, 8w, 12w, and 24w
timeFrame: From enrollment to the end of treatment at 4/8/12/24 weeks
measure: Changes in systolic pressure compared to baseline at 4w, 8w, 12w, and 24w
timeFrame: From enrollment to the end of treatment at 4/8/12/24 weeks
measure: Changes in diastolic pressure compared to baseline at 4w, 8w, 12w, and 24w
timeFrame: From enrollment to the end of treatment at 4/8/12/24 weeks
measure: Changes in body weight compared to baseline at 4w, 8w, 12w, and 24w
timeFrame: From enrollment to the end of treatment at 4/8/12/24 weeks
measure: Changes in waist circumference compared to baseline at 4w, 8w, 12w, and 24w
timeFrame: From enrollment to the end of treatment at 4/8/12/24 weeks
measure: Changes in eGFR compared to baseline at 4w, 8w, 12w, and 24w
timeFrame: From enrollment to the end of treatment at 4/8/12/24 weeks
measure: Changes in C-peptide levels during the 12 and 24 weeks compared to baseline during abdominal and 2-hour postprandial periods
timeFrame: From enrollment to the end of treatment at 12 and 24 weeks
measure: Changes in insulin levels during the 12 and 24 weeks compared to baseline during abdominal and 2-hour postprandial periods
timeFrame: From enrollment to the end of treatment at 12 and 24 weeks
Other outcomes:
Locations:
Study officials:
References: