A Phase 4 interventional study of Dapagliflozin (Forxiga®) and Placebo matching Dapaglifolzin in Type2diabetes, PreDiabetes and Renal Failure, sponsored by University Hospital Tuebingen. Recruiting at 9 sites in Germany. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by University Hospital Tuebingen · Phase 4, Interventional, and Treatment
Among 11 studies testing dapagliflozin in Prediabetic State — 4 open to participants now, 4 under way, none of them phase 3. dapagliflozin · Prediabetic State.
Among the 11 studies testing dapagliflozin in Prediabetic State, this one is the 3rd largest by planned enrollment, is one of 2 that started in 2023, is one of 7 in phase 4, and was the 9th registered.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 170 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →4 of the 11 studies testing dapagliflozin in Prediabetic State are open now, in 4 countries. Each count lists the studies.
dapagliflozin: first FDA approval 2014 (FARXIGA), first EMA approval 2012. What it is approved for, and how studies give it, is on its page →
Of the 145 Prediabetic State studies recruiting now, 51 (35%) set no upper age limit and 84 (58%) stop at 75 or younger; 12 take children under 18; 54 take healthy volunteers.
This study: 35 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 2 started in 2023.
Median enrollment 120 across the 11 interventional studies. Of the 6 that completed or were terminated, 3 (50%) have results posted.
1 of 11 have an industry lead sponsor. The 10 most frequent:
University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.
University Hospital Tuebingen has 5 studies filed under Prediabetic State — fewer than ten, so there is no comparison to draw.
2 of the studies testing dapagliflozin in Prediabetic State that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06054035University Hospital TuebingenSGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes | 2027-06-30 |
| NCT07891234Sherihan AboElyazed Mohamed KhalilEffect of SGLT2 Inhibitor on Metabolic-Dysfunction-Associated Fatty Liver Disease in Patients With Insulin Resistance | 2027-10-01 |
Among the 11 studies testing dapagliflozin in Prediabetic State, from their registry updates:
More than 50% of patients with type 2 diabetes develop micro- and/or macrovascular complications during the course of the disease. Additionally, many patients at risk for diabetes develop metabolically driven complications including kidney and heart disease. Thus, it is of utmost importance to improve prevention of T2D and with this complications. Remission of prediabetes, i.e. normalization of hyperglycemia by means of lifestyle intervention is one of the most effective ways to prevent the development of T2D and complications. Novel sub-phenotyping analysis identified clusters of risk for diabetes associated with different complications, opening opportunities to new therapeutic approaches, despite and in addition to lifestyle changes. So far, pharmacological therapy is not indicated for patients with prediabetes. Remission of hyperglycemia associated with prediabetes during lifestyle interventions not only prevents T2D but is also linked with reduced albuminuria and lower microvascular and kidney complications. Thus, reaching normoglycemia (i.e. prediabetes remission) is important for reducing the risk of (pre-)diabetes-associated complications including micro- and even macrovascular disease. In patients with T2D, recent data show that dapagliflozin can improve diabetes remission, and thus, likely complications. However, to date no data have assessed whether or not this is also true in patients with hyperglycemia related to prediabetes which, as outlined above, already causes different complications.
Subphenotyping of patients with newly onset diabetes suggests that for some individuals, it would be too late to start interventions against dagainst complications at the time of diagnosis of type 2 diabetes. Therefore, individuals at elevated risk to develop T2D and complications should receive preventive measures well before the diagnosis of T2D. This study will provide evidence whether such an early intervention contributes to the remission of hyperglycemia related to prediabetes to protect from associated complications such as renal disease. The studied population will comprise individuals who have hyperglycemia in the range of prediabetes and are thus prone to not only develop T2D, but also early nephropathy but in clinical practice do not receive medical treatment due to the early stage of the disease. These subjects will receive Dapagliflozin 10 mg or Placebo for 6 months. The placebo treatment arm reflects current practice. In order guarantee a benefit the patients in the placebo arm will receive a lifestyle intervention.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Subject (male, female or intersexual) is not willing to use highly effective methods during treatment and for 14 days (male or female) after the end of treatment (highly effective methods are defined as: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).
Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the trial participant and that the vasectomized partner has received medical assessment of the surgical success.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Dapagliflozin (Forxiga®) · Behavioral: Lifestyle Intervention
Drug: Placebo matching Dapaglifolzin · Behavioral: Lifestyle Intervention
Dapagliflozin 10 mg once daily for 6 months. Route of administration: oral.
Placebo matching Dapaglifolzin once daily for 6 months. Route of administration: oral.
Patients receive a conventional lifestyle intervention (one in depth individual session at the beginning and standard care information on a healthy lifestyle at every visit thereafter).
Frequency of remission of hyperglycemia
Frequency of individuals with prediabetes remission (normalization of fasting and 2h glucose concentrations) with dapagliflozin in comparison to treatment with placebo.
Time frame: 6 months
Reduction of urinary albumine-creatinine ratio.
To test differences between the two treatment arms for reduction of urinary albumine-creatinine ratio.
Time frame: 1 month throuhg 6 months
Change in estimated glomerular filtration rate (eGFR)
To test differences between the two treatment arms for reduction in estimated glomerular filtration rate (eGFR).
Time frame: 7 months
Slopes over time of estimated glomerular filtration rate (eGFR).
To test differences between the two treatment arms for slopes over time of estimated glomerular filtration rate (eGFR).
Time frame: baseline to 4 weeks, baseline to 7 months, 3 months to 7 months, baseline to 12 months
Numbers of patients showing resolution of chronic kidney disease (CKD)
To test differences between the two treatment arms for resolution of chronic kidney disease (CKD) for at least 3 months continuously: Urine Albumin Creatinin Ratio (uACR) \< 30mg/g
Time frame: 3 months through 12 months
Prediabetes remission maintenance
Effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on remission of prediabetes as defined in the oGTT a fasting glucose \<100 mg/dl and 2 h glucose \<140 mg/dl at follow up
Time frame: 12 months
Insulin sensitivity
Baseline-adjusted insulin sensitivity at EoT using Insulin sensitivity: ISI-Matsuda/Oral glucose insulin sensitivity index.
Time frame: 6 months, 12 months
Insulin secretion
Baseline-adjusted insulin secretion at EoT using an estimate for insulin secretion: C-peptide0-30AUC/glucose0-30AUC.
Time frame: 6 months, 12 months
Number of patients progressing to Type 2 Diabetes
Effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on the progression to T2DM as defined as a HbA1c ≥ 6.5
Time frame: 6 months, 12 months
Change in body weight
Effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on change in body weight.
Time frame: 6 months, 12 months
Change in BMI
Effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on BMI.
Time frame: 6 months, 12 months
Change in whole body fat
Effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on whole body fat measures by magnetic resonance imaging.
Time frame: 6 months, 12 months
Change in visceral fat
Effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on visceral fat measures by magnetic resonance imaging.
Time frame: 6 months, 12 months
Change in liver fat
Effects of 6 months reatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on liver fat measures by magnetic resonance spectroscopy.
Time frame: 6 months, 12 months
Change in subcutaneous fat
Effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on subcutaneous fat measures by magnetic resonance imaging.
Time frame: 6 months, 12 months
Arterial blood pressure
Baseline-adjusted arterial blood pressure at EoT
Time frame: 6 months, 7 months, 12 months
New onset or progress of neuropathy
Effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on new onset or progress of and neuropathy assessed by using the Rydel-Seiffer tuning fork and a 10 g monofilament
Time frame: 6 months, 12 months
Quality of life using the Short Form Health Survey (SF)-36 questionnaire
Effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on quality of life using the SF-36 questionnaire (scored on a 0 to 100 range; the higher the score, the higher quality of life)
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention for numbers of patients showing a resolution of Prediabetes
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on remission of prediabetes as defined a fasting glucose \<100 mg/dl and 2 h glucose \<140 mg/dl in the OGTT.
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention for change in albuminuria
To test interaction between diabetes risk clusters and intervention for kidney damage as shown by albuminuria in patients with CKD stage G1A2/G2A2 and prediabetes can be improved by a treatment with the SGLT2 inhibitor dapagliflozin (10mg/day) and lifestyle counselling compared to placebo and lifestyle counselling for 6 months calculated as mean of baseline-adjusted uACR measurements with dapagliflozin in comparison to treatment with placebo.
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention for change in estimated glomerular filtration rate (eGFR).
To test interaction between diabetes risk clusters and intervention on estimated glomerular filtration rate (eGFR).
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention for slopes over time of estimated glomerular filtration rate (eGFR).
To test interaction between diabetes risk clusters and intervention on slopes over time of estimated glomerular filtration rate (eGFR).
Time frame: 4 weeks, 3 months, 6 months, 7 months, 12 months
Interaction between diabetes risk cluster and intervention for numbers of patients showing resolution of chronic kidney disease (CKD)
To test interaction between diabetes risk clusters and intervention for resolution of chronic kidney disease (CKD) for at least 3 months continuously: Urine Albumin Creatinin Ratio (uACR) \< 30mg/g
Time frame: 3 months, 6 months, 7 months, 12 months
Interaction between diabetes risk cluster and intervention for insulin sensitivity.
To test interaction between diabetes risk clusters and intervention for baseline-adjusted insulin sensitivity at EoT using Insulin sensitivity: ISI-Matsuda/Oral glucose insulin sensitivity index.
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention for insulin secretion
To test interaction between diabetes risk clusters and intervention for baseline-adjusted insulin secretion at EoT using insulin secretion:C-peptide0-30AUC/glucose0-30AUC.
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention for number of patients progressing to Type 2 Diabetes
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on the progression to T2DM as defined as a HbA1c ≥ 6.5
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention for change in body weight
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on change in body weight.
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention for change in BMI.
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on BMI.
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention for change in whole body fat
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on whole body fat measures by magnetic resonance imaging.
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention for change in visceral fat
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on visceral fat measures by magnetic resonance imaging.
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention for change in liver fat
To test interaction between diabetes risk clusters and intervention for effects effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on liver fat measures by magnetic resonance spectroscopy.
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention for change in subcutaneous fat
To test interaction between diabetes risk clusters and intervention for effects effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on subcutaneous fat measures by magnetic resonance imaging.
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention for change in arterial blood pressure
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on the arterial blood pressure
Time frame: 6 months, 7 months, 12 months
Interaction between diabetes risk cluster and intervention on the new onset or progress of neuropathy
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on the new onset or progress of neuropathy assessed by using the Rydel-Seiffer tuning fork and a 10 g monofilament.
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention for change in quality of life
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on the quality of life using the SF-36 questionnaire (scored on a 0 to 100 range; the higher the score, the higher quality of life).
Time frame: 6 months, 12 months
Small vessel density
Change in small vessel density and junction-to-endpoint branches between baseline and EoT in the dapagliflozin versus placebo group as assessed by optoacustic imagingMyocardial function
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention on small vessel density
To test interaction between diabetes risk clusters and intervention for change in small vessel density and junction-to-endpoint branches between baseline and EoT in the dapagliflozin versus placebo group as assessed by optoacustic imagingMyocardial function
Time frame: 6 months, 12 months
New onset or progress of diabetic retinopathy
New onset or progress of retinopathy between baseline and EoT in the dapagliflozin versus placebo group. This will be assessed by a grading algorithm using the iCare DRSplus camera. Since macula edema at early stages cannot adequately be assessed with fundus pictures, we will assess maculopathies using optical coherence tomography
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention on the new onset or progress of diabetic retinopathy
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on the new onset or progress of retinopathy between baseline and EoT in the dapagliflozin versus placebo group. This will be assessed by a grading algorithm using the iCare DRSplus camera. Since macula edema at early stages cannot adequately be assessed with fundus pictures, we will assess maculopathies using optical coherence tomography.
Time frame: 6 months, 12 months
Composition of the gut microbiome
Change in gut microbial community and gene abundances within and between intervention and placebo groups over time using next generation sequencing data and machine learning algorithms
Time frame: 3 months, 6 months, 7 months, 12 months
Interaction between diabetes risk cluster and intervention for composition of the gut microbiome
To test interaction between diabetes risk clusters and intervention change in gut microbial community and gene abundances within and between intervention and placebo groups over time using next generation sequencing data and machine learning algorithms
Time frame: 3 months, 6 months, 7 months, 12 months
Urinary metabolite signature of SGLT2 inhibitors
Changes in urinary metabolites within and between intervention and placebo groups over time using MS-based metabolomics and machine learning algorithms
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention for urinary metabolite signature of SGLT2 inhibitors
To test interaction between diabetes risk clusters and intervention changes in urinary metabolites within and between intervention and placebo groups over time using MS-based metabolomics and machine learning algorithms
Time frame: 6 months, 12 months
Myocardial function shown by left ventricular mass index
Effects of dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on left ventricular mass index assessed via cardiac magnetic resonance imaging
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention on Myocardial function shown by left ventricular mass index
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on left ventricular mass index assessed via cardiac magnetic resonance imaging.
Time frame: 6 months, 12 months
Myocardial function shown by systolic myocardial function
Effects of dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on systolic myocardial function assessed via cardiac magnetic resonance imaging.
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention on Myocardial function shown by systolic myocardial function
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on systolic myocardial function assessed via cardiac magnetic resonance imaging.
Time frame: 6 months, 12 months
Myocardial function shown by diastolic myocardial function
Effects of dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on diastolic myocardial function assessed via cardiac magnetic resonance imaging.
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention on Myocardial function shown by diastolic myocardial function
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on diastolic myocardial function assessed via cardiac magnetic resonance imaging.
Time frame: 6 months, 12 months
Health economic evaluation shown by incremental cost-effectiveness ratio
Conducting a health economic evaluation from the perspective of the statutory health insurance and society in from of a cost-effectiveness analysis
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention on health economic evaluation shown by incremental cost-effectiveness ratio
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on health economic evaluation shown by incremental cost-effectiveness ratio of a cost-effectiveness analysis
Time frame: 6 months, 12 months
Health economic evaluation shown by incremental cost-utility ratio
Conducting a health economic evaluation from the perspective of the statutory health insurance and society in from of a cost-utility analysis
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention on health economic evaluation shown by incremental cost-utility ratio
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on health economic evaluation shown by incremental cost-utility ratio of a cost-utility analysis
Time frame: 6 months, 12 months
Changes in risk preferences
To test differences between the two treatment arms for the risk preferences
Time frame: 6 months, 12 months
Changes in time preferences
To test differences between the two treatment arms for the time preferences
Time frame: 6 months, 12 months
Interaction between diabetes risk cluster and intervention on prediabetes remission maintenance
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on remission of prediabetes as defined in the oGTT a fasting glucose \<100 mg/dl and 2 h glucose \<140 mg/dl at follow up.
Time frame: 12 months
Interaction between diabetes risk cluster and intervention on the risk preferences
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on change of risk preferences
Time frame: 6 months
Interaction between diabetes risk cluster and intervention on the risk preferences
To test interaction between diabetes risk clusters and intervention for effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on change of time preferences
Time frame: 6 months
Started Oct 2023 (actual). Primary completion is estimated for Jun 2027, 44 months after the start.
Of 30 phase 4 interventional studies under Prediabetic State, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 47. This study's planned 44 months is close to that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dapagliflozin
University Hospital Tuebingen →