Prediabetic StatePhase 2NCT05914857
Evaluation of the Safety and Efficacy of SGLT2 Inhibitors in Pre-diabetic Patients
A Phase 2 study testing Dapagliflozin 10mg Tab and lifestyle interventions in people with Prediabetic State and Impaired Fasting Glucose, run by Yangjin at 1 site in China.
Trial summary
Pre-diabetes is a state characterized by subclinical impairment in glycemic variables that is intermediate between normal glucose tolerance (NGT) and diabetes. There are two frequently used definitions for pre-diabetes, one from the American Diabetes Association (ADA) and another from the World Health Organization… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prediabetic State, Impaired Fasting Glucose, Impaired Glucose Tolerance
- What is being tested?
- Dapagliflozin 10mg Tab and lifestyle interventions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2023to 1 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 ~65 years old;
- OGTT received within half a year and were diagnosed with prediabetes In accordance with the gout classification criteria of the American Diabetes Association: ① Fasting blood glucose (FPG)≥6.1 mmol/L and < 7.0 mmol/L; ② The blood glucose (2h-PG) concentration at OGTT 2h was ≥7.8 and < 11.1mmol/L; ③ Glycosylated hemoglobin (HbA1c) ≥5.7% and < 6.4%;
- No antidiabetic drugs (including traditional Chinese medicine) were taken within 6 months before screening;
- Sign the informed consent form.
Who cannot join
- Diagnosed with diabetes;
- Taking medications that affect glucose and lipid metabolism (excluding thiazide diuretics at a daily dose of ≤ 12.5 mg);
- Taking weight-loss drugs (including traditional Chinese medicine) within 6 months before screening;
- Patients with acute infection, surgery, acute alcoholism, mental illness, etc;
- Patients with liver and kidney dysfunction, severe chronic gastrointestinal disease, uncontrolled thyroid disease, cancer, and ventilator use;
- Systolic blood pressure ≥180 mmHg (1 mmHg = 0.133 kPa) or diastolic blood pressure ≥110 mmHg at screening;
Show all 12Show fewer
- Electrocardiogram within 12 weeks before screening indicating arrhythmia requiring urgent diagnosis or treatment (e.g., clinically newly identified severe arrhythmia or conduction disturbance), myocardial infarction, unstable angina, or stroke requiring cardiovascular and cerebrovascular intervention;
- A history of traumatic amputation within the past year, or active skin ulcers, osteomyelitis, gangrene, or critical lower limb ischemia within the past 6 months;
- Enrolled in drug/device clinical studies (including vaccines) within 12 weeks before screening;
- Pregnant, lactating women, or those planning a recent pregnancy;
- Allergic constitution or multi-drug allergy;
- Receiving bariatric surgery within the past 2 years.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Jin Yang, Doctorate, 82122515, yangjin@bjmu.edu.cn
About this study
Official title: Evaluation of the Safety and Efficacy of SGLT2 Inhibitors in Pre-diabetic Patients: A Randomized Trial
Pre-diabetes is a state characterized by subclinical impairment in glycemic variables that is intermediate between normal glucose tolerance (NGT) and diabetes. There are two frequently used definitions for pre-diabetes, one from the American Diabetes Association (ADA) and another from the World Health Organization (WHO), and both include impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and a calibrated hemoglobin A1c (HbA1c) of between 5.7 and 6.4%. More than 30 % of the global population demonstrated one or more forms of prediabetic dysglycaemia. In general, approximately 70 % of individuals with IFG and/or IGT can expect to go on to develop clinical type 2 diabetes at some time in the future, and the risk increases with higher HbA1c levels and with higher BMI. Worse still, the prevalence of pre-diabetes is increasing worldwide, with a growing number of patients progressing to diabetes. Identification and treatment of pre-diabetic individuals is therefore crucial. Recent evidence suggested that preventing progression of pre-diabetes to diabetes is possible, and thus efficacious interventions for pre-diabetic individuals are the cornerstone of diabetes prevention.
The current paradigm for diabetes prevention in high-risk individuals focuses on achieving moderate weight loss via dietary change and increasing physical activity. However, lifestyle-based weight-loss strategies may initially be successful, but difficult to achieve or maintain.
Read more
In many cases, pharmacologic treatments may be needed to regulate blood glucose. Randomized clinical trials (RCTs) have verified the efficacy of metformin in preventing insulin resistance syndrome, along with the progression of microvascular diseases and heart attacks. Meanwhile, clinical experience and trial data have yielded almost no significant safety concerns for metformin. Nonetheless, it may cause discomfort for up to 25% of patients who experience diarrhea and nausea subsequent to its administration. For patients with a contraindication or intolerable adverse effects to metformin, Sodium Glucose Cotransporter 2 (SGLT-2) inhibitors with novel mode of action may be another alternative.
Large clinical trials have not yet identified a substantial elevation in the frequency of adverse reactions related to SGLT-2 inhibitors when compared to the placebo group. Inhibition of SGLT-2 has some extra advantages for diabetes management over other therapeutic approaches. Firstly, the SGLT-2 is exclusively expressed in renal proximal tubules, and thus selective inhibitors will exert a glucose-lowering effect, independently of insulin secretion. Therefore, SGLT-2 inhibitors can cause weight loss without inducing major hypoglycemic events. Secondly, the cardiovascular benefits of SGLT-2 inhibitors was supported by large clinical trials in the modern context of antiplatelet, statin, and blood pressure management, which may match many of the advantages of metformin. Thirdly, SGLT-2 inhibitors have also been proven to prevent nephropathy for its restriction on albuminuria and inflammatory processes, and to subsequently dampen the deterioration in renal function. Overall, SGLT-2 inhibitors have demonstrated safety in non-diabetic patients, particularly in those afflicted with heart or kidney failure, and have shown to provide additional benefits.
At present, the overall effectiveness and safety of SGLT-2 inhibitors in improving metabolism of pre-diabetic patients are still unclear. The purpose of this experiment is to evaluate the effect of SGLT-2 inhibitor on pre-diabetic patients.
Read the detailed description
- Study design This study is a prospective, single-center parallel-group trial conducted at the Third Hospital of Peking University. Pre-diabetic patients will be included in the study if they meet the inclusion and exclusion criteria. The participants will be stratified by gender (male: female =1:1) and then randomly allocated to the intervention and control groups using a random number table. Patients in the intervention group will be administered Dapagliflozin 10 mg/day in addition to lifestyle intervention, while patients in the control group will be given lifestyle intervention only. Recommended lifestyle interventions include 30 minutes of moderate intensity exercise per day, with a total calorie reduction of 300 calories, according to Intervention for Adults with Pre-diabetes: A Chinese Expert Consensus. The specific goals of lifestyle intervention include achieving or approaching a BMI of 24 kg/m2 for overweight or obese individuals, or at least a 5% initial weight loss within 3-6 months. Patients should not initiate during the study an organized diet and/or exercise weight reduction program other than the lifestyle and dietary measures for diabetes treatment. Study participants should be instructed not to donate blood or blood products during the study. Physical activity: For optimal physical fitness, it is highly recommended to incorporate a combination of aerobic and resistance exercises daily for a minimum of 30 minutes. Aerobic exercises, including brisk walking, jogging, cycling, and swimming, should be performed at least three times weekly. Resistance exercises, which entail the utilization of resistance training equipment or free weights (such as dumbbells and barbells), should be integrated into the exercise regimen at least twice a week, in conjunction with regular aerobic exercise. Dietary intervention: It is recommended that the daily total energy requirement comprises of 45%-60% from carbohydrates, 25%-35% from fats, and 15%-20% from protein. Additionally, it is advised that the daily dietary energy intake be reduced by a minimum of 300 kCal. Furthermore, it is crucial to limit the intake of saturated fatty acids to less than 30% of the total fat intake, and restrict daily salt intake to no more than 6g. Lastly, it is not advisable to consume alcohol, or if consumed, it must be included in the total energy intake. A sample size estimation is implemented for this trial based on the comparison of the intervention and control groups with respect to the primary efficacy end point, the change from baseline at 12 weeks in 2h plasma glucose on an oral glucose tolerance test (OGTT) (2h-PG). The estimated decrease of 2hPG in the intervention and the control group is 2% and 1%, respectively. Additionally, participants will be stratified according to gender, as one purpose of this study is to explore whether and to what extent the drug has adverse effects on various genitourinary system. After a careful search of the relevant literature, the ratio of male to female pre-diabetic patients is approximately 1:1. Therefore, under the assumption of an estimated 10% dropout rate at 12 weeks in this trial, a total sample size of 120 participants, including 30 participants allocating to the intervention group and 30 participants to the control group in each gender, will provide the trial with 80% power to demonstrate the superiority of treatment with the use of a two-sample t-test at a two-sided alpha level of 0.05. Previous studies have indicated that approximately 30% of patients are over the age of 50, so it is anticipated to include:
- 42 males under 50 years old B. 18 men aged 50-65. C. 42 women under 50 years old. D. 18 women aged 50-65.
- Research process 1) Screening period. Individuals who meet the inclusion criteria and demonstrate good adherence to medication regimens will be eligible for inclusion in the study, and will be randomly assigned to the intervention and control groups. Subsequently, their basic information will be collected, including age, sex, body mass index (BMI), blood pressure, abdominal circumference, smoking history, cardiovascular disease history, amputation history, use of hypoglycemic and/or slimming drugs, history of biochemical hypoglycemia serious liver disease history, malignant tumor history, stroke history, and urogenital infection history. Then participants will undergo serial blood and urine testing for blood glucose and other metabolism parameters. Male participants may also receive semen analysis voluntarily. Finally, patients in the intervention group will be administered Dapagliflozin 10 mg/day in addition to lifestyle intervention, while patients in the control group will be only given lifestyle intervention.
- Follow-up stage. The follow-up cycle will be computed subsequent to the initiation of the intervention. Telephone follow-up will be carried out at week 4 and week 8 to assess the subjects' adherence to the prescribed medication, evaluate any potential adverse drug reactions, and record the type and time of physical activities. Concurrently, we will conduct patient education, optimize their treatment plans, and collect the incidence of pregnancy. Corresponding data will be recorded on the case report form.
During the final visit, clinical information of the participants will be obtained, including body mass index (BMI), blood pressure (BP), and waist circumference (WC). For female participants, pregnancy will be confirmed. In addition, serial blood and urine tests will be performed to examine blood glucose and other metabolic parameters. Finally, a summary of the experiment's process will be documented.
3.Statistical analysis We will utilize SPSS 25.0 software for statistical analysis. All statistical tests are two-tailed tests, and a P value of less than or equal to 0.05 will be considered statistically significant. Continuous data will be presented as mean ± SD if the measurement data are normally distributed. An independent sample t-test will be used to compare the different therapeutic effects between the parameters with and without the intervention of SGLT-2 inhibitors. Counting data will be represented as medians and interquartile ranges [IQRs], and compared using a Chi-square test between groups. Spearman's correlation analysis and binary logistic regression analysis will be employed for correlation analysis.
- Being tested
- Dapagliflozin 10mg Tab, lifestyle interventions
- Keywords
- Prediabetic State, Impaired Fasting Glucose, Impaired Glucose Tolerance, Sodium-glucose co-transporter 2 inhibitor, Dapagaliflozin
- Medical subject headings
- Prediabetic State, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Also called Dapagliflozin Tablets
Dapagliflozin Tablets, Oral, 10mg, Once daily
lifestyle interventionsBehavioural
Consisting of 30 minutes of moderate-intensity exercise every day and a reduction of 300 calories in the total diet
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients in the intervention group will be administered Dapagliflozin 10 mg/day in addition to lifestyle intervention. Receives: Drug: Dapagliflozin 10mg Tab; Behavioral: lifestyle interventions |
| Control group | Placebo comparator | Patients in the control group will be given lifestyle intervention only. Receives: Behavioral: lifestyle interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
2h plasma glucose on an oral glucose tolerance test (OGTT)
2h-PG change
Measured: Change from baseline (time 0) to study end (12 weeks)
Secondary outcomes (8)
Change in HbA1c
fasting serum HbA1c change
Measured: Change from baseline (time 0) to study end (12 weeks)
Change in Body Weight
fasting body weight change
Measured: Change from baseline (time 0) to study end (12 weeks)
Change in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Change in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Measured: Change from baseline (time 0) to study end (12 weeks)
Change in Waist Circumference (WC)
Change in Waist Circumference (WC)
Measured: Change from baseline (time 0) to study end (12 weeks)
Glycemic control including Fasting Blood Glucose (FBG) and Glycosylated Hemoglobin (HbA1C)
Glycemic control including Fasting Blood Glucose (FBG) and Glycosylated
Measured: Change from baseline (time 0) to study end (12 weeks)
Plasma lipid fractions including Total Cholesterol Levels (CHOL) and Triglyceride (TRG) Levels
Plasma lipid fractions including Total Cholesterol Levels (CHOL) and Triglyceride
Measured: Change from baseline (time 0) to study end (12 weeks)
Liver Enzymes including ALT and AST levels
Liver Enzymes including ALT and AST levels
Measured: Change from baseline (time 0) to study end (12 weeks)
Creatinine, calculated eGFR, and Albumin/Creatinine Ratio (ACR)
Creatinine, calculated eGFR, and Albumin/Creatinine Ratio (ACR)
Measured: Change from baseline (time 0) to study end (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start20 Dec 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yangjin
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital
- Responsible party
- Sponsor-investigator, Yangjin, Peking University Third Hospital
- Investigators
- Jin Yang, doctorate, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914857
- Sponsor's protocol ID
- 80497
- Status last verified
- Jul 2023
- First submitted
- 6 May 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu X, Xia L, Yin D, Yang J, Wei R. Evaluating the Safety and Efficacy of Sodium-Glucose Co-transporter 2 Inhibitors in Subjects with Prediabetes: A Protocol for a Randomized Controlled Trial. Diabetes Ther. 2024 May;15(5):1231-1244. doi: 10.1007/s13300-024-01560-3. Epub 2024 Mar 18.
PubMed 38494571
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of SGLT2 Inhibitors in Pre-diabetic Patients: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05914857
- Acronym / sponsor ID
- 80497
- Keywords
- Prediabetic State, Impaired Fasting Glucose, Impaired Glucose Tolerance, Sodium-glucose co-transporter 2 inhibitor, Dapagaliflozin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- YangjinUniversity, hospital or other
- Collaborators
- Peking University Third Hospital
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 Jun 2023 (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.
Pre-diabetes is a state characterized by subclinical impairment in glycemic variables that is intermediate between normal glucose tolerance (NGT) and diabetes. There are two frequently used definitions for pre-diabetes, one from the American Diabetes Association (ADA) and another from the World Health Organization (WHO), and both include impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and a calibrated hemoglobin A1c (HbA1c) of between 5.7 and 6.4%. More than 30 % of the global population demonstrated one or more forms of prediabetic dysglycaemia. In general, approximately 70 % of individuals with IFG and/or IGT can expect to go on to develop clinical type 2 diabetes at some time in the future, and the risk increases with higher HbA1c levels and with higher BMI. Worse still, the prevalence of pre-diabetes is increasing worldwide, with a growing number of patients progressing to diabetes. Identification and treatment of pre-diabetic individuals is therefore crucial. Recent evidence suggested that preventing progression of pre-diabetes to diabetes is possible, and thus efficacious interventions for pre-diabetic individuals are the cornerstone of diabetes prevention.
The current paradigm for diabetes prevention in high-risk individuals focuses on achieving moderate weight loss via dietary change and increasing physical activity. However, lifestyle-based weight-loss strategies may initially be successful, but difficult to achieve or maintain.
In many cases, pharmacologic treatments may be needed to regulate blood glucose. Randomized clinical trials (RCTs) have verified the efficacy of metformin in preventing insulin resistance syndrome, along with the progression of microvascular diseases and heart attacks. Meanwhile, clinical experience and trial data have yielded almost no significant safety concerns for metformin. Nonetheless, it may cause discomfort for up to 25% of patients who experience diarrhea and nausea subsequent to its administration. For patients with a contraindication or intolerable adverse effects to metformin, Sodium Glucose Cotransporter 2 (SGLT-2) inhibitors with novel mode of action may be another alternative.
Large clinical trials have not yet identified a substantial elevation in the frequency of adverse reactions related to SGLT-2 inhibitors when compared to the placebo group. Inhibition of SGLT-2 has some extra advantages for diabetes management over other therapeutic approaches. Firstly, the SGLT-2 is exclusively expressed in renal proximal tubules, and thus selective inhibitors will exert a glucose-lowering effect, independently of insulin secretion. Therefore, SGLT-2 inhibitors can cause weight loss without inducing major hypoglycemic events. Secondly, the cardiovascular benefits of SGLT-2 inhibitors was supported by large clinical trials in the modern context of antiplatelet, statin, and blood pressure management, which may match many of the advantages of metformin. Thirdly, SGLT-2 inhibitors have also been proven to prevent nephropathy for its restriction on albuminuria and inflammatory processes, and to subsequently dampen the deterioration in renal function. Overall, SGLT-2 inhibitors have demonstrated safety in non-diabetic patients, particularly in those afflicted with heart or kidney failure, and have shown to provide additional benefits.
At present, the overall effectiveness and safety of SGLT-2 inhibitors in improving metabolism of pre-diabetic patients are still unclear. The purpose of this experiment is to evaluate the effect of SGLT-2 inhibitor on pre-diabetic patients.
Detailed description
- Study design This study is a prospective, single-center parallel-group trial conducted at the Third Hospital of Peking University. Pre-diabetic patients will be included in the study if they meet the inclusion and exclusion criteria. The participants will be stratified by gender (male: female =1:1) and then randomly allocated to the intervention and control groups using a random number table. Patients in the intervention group will be administered Dapagliflozin 10 mg/day in addition to lifestyle intervention, while patients in the control group will be given lifestyle intervention only. Recommended lifestyle interventions include 30 minutes of moderate intensity exercise per day, with a total calorie reduction of 300 calories, according to Intervention for Adults with Pre-diabetes: A Chinese Expert Consensus. The specific goals of lifestyle intervention include achieving or approaching a BMI of 24 kg/m2 for overweight or obese individuals, or at least a 5% initial weight loss within 3-6 months. Patients should not initiate during the study an organized diet and/or exercise weight reduction program other than the lifestyle and dietary measures for diabetes treatment. Study participants should be instructed not to donate blood or blood products during the study. Physical activity: For optimal physical fitness, it is highly recommended to incorporate a combination of aerobic and resistance exercises daily for a minimum of 30 minutes. Aerobic exercises, including brisk walking, jogging, cycling, and swimming, should be performed at least three times weekly. Resistance exercises, which entail the utilization of resistance training equipment or free weights (such as dumbbells and barbells), should be integrated into the exercise regimen at least twice a week, in conjunction with regular aerobic exercise. Dietary intervention: It is recommended that the daily total energy requirement comprises of 45%-60% from carbohydrates, 25%-35% from fats, and 15%-20% from protein. Additionally, it is advised that the daily dietary energy intake be reduced by a minimum of 300 kCal. Furthermore, it is crucial to limit the intake of saturated fatty acids to less than 30% of the total fat intake, and restrict daily salt intake to no more than 6g. Lastly, it is not advisable to consume alcohol, or if consumed, it must be included in the total energy intake. A sample size estimation is implemented for this trial based on the comparison of the intervention and control groups with respect to the primary efficacy end point, the change from baseline at 12 weeks in 2h plasma glucose on an oral glucose tolerance test (OGTT) (2h-PG). The estimated decrease of 2hPG in the intervention and the control group is 2% and 1%, respectively. Additionally, participants will be stratified according to gender, as one purpose of this study is to explore whether and to what extent the drug has adverse effects on various genitourinary system. After a careful search of the relevant literature, the ratio of male to female pre-diabetic patients is approximately 1:1. Therefore, under the assumption of an estimated 10% dropout rate at 12 weeks in this trial, a total sample size of 120 participants, including 30 participants allocating to the intervention group and 30 participants to the control group in each gender, will provide the trial with 80% power to demonstrate the superiority of treatment with the use of a two-sample t-test at a two-sided alpha level of 0.05. Previous studies have indicated that approximately 30% of patients are over the age of 50, so it is anticipated to include:
- 42 males under 50 years old B. 18 men aged 50-65. C. 42 women under 50 years old. D. 18 women aged 50-65.
- Research process 1) Screening period. Individuals who meet the inclusion criteria and demonstrate good adherence to medication regimens will be eligible for inclusion in the study, and will be randomly assigned to the intervention and control groups. Subsequently, their basic information will be collected, including age, sex, body mass index (BMI), blood pressure, abdominal circumference, smoking history, cardiovascular disease history, amputation history, use of hypoglycemic and/or slimming drugs, history of biochemical hypoglycemia serious liver disease history, malignant tumor history, stroke history, and urogenital infection history. Then participants will undergo serial blood and urine testing for blood glucose and other metabolism parameters. Male participants may also receive semen analysis voluntarily. Finally, patients in the intervention group will be administered Dapagliflozin 10 mg/day in addition to lifestyle intervention, while patients in the control group will be only given lifestyle intervention.
- Follow-up stage. The follow-up cycle will be computed subsequent to the initiation of the intervention. Telephone follow-up will be carried out at week 4 and week 8 to assess the subjects' adherence to the prescribed medication, evaluate any potential adverse drug reactions, and record the type and time of physical activities. Concurrently, we will conduct patient education, optimize their treatment plans, and collect the incidence of pregnancy. Corresponding data will be recorded on the case report form.
During the final visit, clinical information of the participants will be obtained, including body mass index (BMI), blood pressure (BP), and waist circumference (WC). For female participants, pregnancy will be confirmed. In addition, serial blood and urine tests will be performed to examine blood glucose and other metabolic parameters. Finally, a summary of the experiment's process will be documented.
3.Statistical analysis We will utilize SPSS 25.0 software for statistical analysis. All statistical tests are two-tailed tests, and a P value of less than or equal to 0.05 will be considered statistically significant. Continuous data will be presented as mean ± SD if the measurement data are normally distributed. An independent sample t-test will be used to compare the different therapeutic effects between the parameters with and without the intervention of SGLT-2 inhibitors. Counting data will be represented as medians and interquartile ranges [IQRs], and compared using a Chi-square test between groups. Spearman's correlation analysis and binary logistic regression analysis will be employed for correlation analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Dapagliflozin 10mg Tab, Behavioral: lifestyle interventionsPatients in the intervention group will be administered Dapagliflozin 10 mg/day in addition to lifestyle intervention. |
| Control group | Placebo comparator | Behavioral: lifestyle interventionsPatients in the control group will be given lifestyle intervention only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 ~65 years old;
- OGTT received within half a year and were diagnosed with prediabetes In accordance with the gout classification criteria of the American Diabetes Association: ① Fasting blood glucose (FPG)≥6.1 mmol/L and < 7.0 mmol/L; ② The blood glucose (2h-PG) concentration at OGTT 2h was ≥7.8 and < 11.1mmol/L; ③ Glycosylated hemoglobin (HbA1c) ≥5.7% and < 6.4%;
- No antidiabetic drugs (including traditional Chinese medicine) were taken within 6 months before screening;
- Sign the informed consent form.
Key exclusion criteria (12 listed)
- Diagnosed with diabetes;
- Taking medications that affect glucose and lipid metabolism (excluding thiazide diuretics at a daily dose of ≤ 12.5 mg);
- Taking weight-loss drugs (including traditional Chinese medicine) within 6 months before screening;
- Patients with acute infection, surgery, acute alcoholism, mental illness, etc;
- Patients with liver and kidney dysfunction, severe chronic gastrointestinal disease, uncontrolled thyroid disease, cancer, and ventilator use;
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 |
|---|---|---|
| Dapagliflozin 10mg TabAlso: Dapagliflozin TabletsDapagliflozin Tablets, Oral, 10mg, Once daily | Drug | Intervention group |
| lifestyle interventionsConsisting of 30 minutes of moderate-intensity exercise every day and a reduction of 300 calories in the total diet | Behavioural | Control group, Intervention group |
Primary outcome
2h plasma glucose on an oral glucose tolerance test (OGTT)
Time frame: Change from baseline (time 0) to study end (12 weeks)
2h-PG change
8 secondary outcomes
Change in HbA1c
Time frame: Change from baseline (time 0) to study end (12 weeks)
Change in Body Weight
Time frame: Change from baseline (time 0) to study end (12 weeks)
Change in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Time frame: Change from baseline (time 0) to study end (12 weeks)
Change in Waist Circumference (WC)
Time frame: Change from baseline (time 0) to study end (12 weeks)
Glycemic control including Fasting Blood Glucose (FBG) and Glycosylated Hemoglobin (HbA1C)
Time frame: Change from baseline (time 0) to study end (12 weeks)
Plasma lipid fractions including Total Cholesterol Levels (CHOL) and Triglyceride (TRG) Levels
Time frame: Change from baseline (time 0) to study end (12 weeks)
Liver Enzymes including ALT and AST levels
Time frame: Change from baseline (time 0) to study end (12 weeks)
Creatinine, calculated eGFR, and Albumin/Creatinine Ratio (ACR)
Time frame: Change from baseline (time 0) to study end (12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Derived from this study: PubMed 38494571Zhu X, Xia L, Yin D, Yang J, Wei R. Evaluating the Safety and Efficacy of Sodium-Glucose Co-transporter 2 Inhibitors in Subjects with Prediabetes: A Protocol for a Randomized Controlled Trial. Diabetes Ther. 2024 May;15(5):1231-1244. doi: 10.1007/s13300-024-01560-3. Epub 2024 Mar 18.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jin Yang, doctorate principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin 10mg Tab and lifestyle interventions in people with Prediabetic State and Impaired Fasting Glucose, run by Yangjin at 1 site in China.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Yang, Associate chief physician (82122515, yangjin@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2h plasma glucose on an oral glucose tolerance test (OGTT) (time frame: Change from baseline (time 0) to study end (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05914857, which also lists 1 linked publication.
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 25 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.