Type 2 DiabetesPhase 4NCT06417489
Evaluation of Efficacy and Safety of Combination Therapy of Henagliflozin Proline, Retagliptin and Metformin in New Diagnosed Type 2 Diabetes Patients
A Phase 4 study testing Combination therapy and Sequential treatment group in people with Type 2 Diabetes, run by Peking University First Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Combination therapy and Sequential treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2024to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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\<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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Combination therapy, Sequential treatment group
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination therapyDrug
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.
Sequential treatment groupDrug
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 Prolinewas 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Sequential treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with HbA1c<7% at 12w
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (15)
The proportion of subjects with HbA1c<7% at week 24
Measured: From enrollment to the end of treatment at 24 weeks
The proportion of subjects with HbA1c<6.5% at 12 week
Measured: From enrollment to the end of treatment at 12 weeks
The proportion of subjects with HbA1c<6.5% at 24 week
Measured: From enrollment to the end of treatment at 24 weeks
Changes in HbA1c compared to baseline at 12 weeks
Measured: From enrollment to the end of treatment at 12 weeks
Changes in HbA1c compared to baseline at 24 weeks
Measured: From enrollment to the end of treatment at 24 weeks
Changes in fingertip blood glucose (seven point blood glucose spectrum) compared to baseline at 4w, 8w, 12w, and 24w
Measured: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in 2hPPG compared to baseline at 4w, 8w, 12w, and 24w
Measured: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in FBG compared to baseline at 4w, 8w, 12w, and 24w
Measured: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in systolic pressure compared to baseline at 4w, 8w, 12w, and 24w
Measured: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in diastolic pressure compared to baseline at 4w, 8w, 12w, and 24w
Measured: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in body weight compared to baseline at 4w, 8w, 12w, and 24w
Measured: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in waist circumference compared to baseline at 4w, 8w, 12w, and 24w
Measured: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in eGFR compared to baseline at 4w, 8w, 12w, and 24w
Measured: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in C-peptide levels during the 12 and 24 weeks compared to baseline during abdominal and 2-hour postprandial periods
Measured: From enrollment to the end of treatment at 12 and 24 weeks
Changes in insulin levels during the 12 and 24 weeks compared to baseline during abdominal and 2-hour postprandial periods
Measured: From enrollment to the end of treatment at 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start31 May 2024 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417489
- Sponsor's protocol ID
- 2024-165-002
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06417489
- Acronym / sponsor ID
- 2024-165-002
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 31 May 2024 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination therapy | Experimental | Drug: Combination therapyHenagliflozin 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. |
| Sequential treatment group | Active comparator | Drug: Sequential treatment groupMetformin, 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination therapyHenagliflozin 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 groupMetformin, 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 Prolinewas 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 |
Primary outcome
Proportion of subjects with HbA1c<7% at 12w
Time frame: From enrollment to the end of treatment at 12 weeks
15 secondary outcomes
The proportion of subjects with HbA1c<7% at week 24
Time frame: From enrollment to the end of treatment at 24 weeks
The proportion of subjects with HbA1c<6.5% at 12 week
Time frame: From enrollment to the end of treatment at 12 weeks
The proportion of subjects with HbA1c<6.5% at 24 week
Time frame: From enrollment to the end of treatment at 24 weeks
Changes in HbA1c compared to baseline at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Changes in HbA1c compared to baseline at 24 weeks
Time frame: From enrollment to the end of treatment at 24 weeks
Changes in fingertip blood glucose (seven point blood glucose spectrum) compared to baseline at 4w, 8w, 12w, and 24w
Time frame: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in 2hPPG compared to baseline at 4w, 8w, 12w, and 24w
Time frame: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in FBG compared to baseline at 4w, 8w, 12w, and 24w
Time frame: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in systolic pressure compared to baseline at 4w, 8w, 12w, and 24w
Time frame: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in diastolic pressure compared to baseline at 4w, 8w, 12w, and 24w
Time frame: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in body weight compared to baseline at 4w, 8w, 12w, and 24w
Time frame: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in waist circumference compared to baseline at 4w, 8w, 12w, and 24w
Time frame: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in eGFR compared to baseline at 4w, 8w, 12w, and 24w
Time frame: From enrollment to the end of treatment at 4/8/12/24 weeks
Changes in C-peptide levels during the 12 and 24 weeks compared to baseline during abdominal and 2-hour postprandial periods
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
Changes in insulin levels during the 12 and 24 weeks compared to baseline during abdominal and 2-hour postprandial periods
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combination therapy and Sequential treatment group in people with Type 2 Diabetes, run by Peking University First Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junqing Zhang (8613611167278, nan.gu@pkufh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with HbA1c<7% at 12w (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.