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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
| German Center for Diabetes Research | OTHER |
| AstraZeneca | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin (Forxiga®) and lifestyle counselling | Experimental |
| |
| Placebo matching Dapaglifolzin and lifestyle counselling | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin (Forxiga®) | Drug | Dapagliflozin 10 mg once daily for 6 months. Route of administration: oral. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of urinary albumine-creatinine ratio. | To test differences between the two treatment arms for reduction of urinary albumine-creatinine ratio. | 1 month throuhg 6 months |
| Change in estimated glomerular filtration rate (eGFR) |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | Baseline-adjusted insulin sensitivity at EoT using Insulin sensitivity: ISI-Matsuda/Oral glucose insulin sensitivity index. | 6 months, 12 months |
| Insulin secretion | Baseline-adjusted insulin secretion at EoT using an estimate for insulin secretion: C-peptide0-30AUC/glucose0-30AUC. |
Inclusion criteria:
Exclusion Criteria
Manifest diabetes mellitus
eGFR (as calculated by the CKD-EPI equation) < 60 ml/min/1.73 m2
all glucose altering medications (including current therapy with dapagliflozin or empagliflozin or any other SGLT2-Inhibitor)
Symptomatic chronic congestive heart disease
New diuretic or antihypertensive medication or dosing changes within the last 2 weeks, for aldosterone antagonists within the last 6 weeks
known or suspected orthostatic proteinuria
any acute severe or chronic severe illness, including the following: malignant disease ongoing or < 5 years ago, unstable cardiovascular disease or procedure within 3 months prior to enrolment or expected to require coronary revascularisation procedure
history of or current therapy for congestive heart failure (NYHA III and IV), pacemaker or aortic stenosis > II°
acute pancreatic disease (i.e. elevated lipase 3x ULN)
rapidly progressing renal disease or anuria
known HIV infection or positive HIV test at screening
history of or planned organ transplantation
history or presence of inflammatory bowel disease or other severe gastrointestinal diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis
relevant hepatic disease, including, but not limited to, acute hepatitis, chronic active hepatitis, or severe hepatic insufficiency, including patients with alanine aminotransferase and/or aspartate aminotransferase > 3 x upper limit of normal and/or total bilirubin (TB) > 2 mg/dL (> 34.2 μmol/L) (patients with TB > 2 mg/dL [> 34.2 μmol/L] and documented Gilbert's syndrome will be allowed to participate).
treatment with glucocorticoids
antibiotic treatment within the last 4 weeks
History of ketoacidosis
history of repeated urogenital infection
hemoglobinopathies, haemolytic anaemia, or chronic anaemia (haemoglobin concentration <12.0 g/dL)
presence of psychiatric disorder or new intake of antidepressant or antipsychotic agents(start within last 3 months)
Positive Screening for a severe depression (BDI ≥29)
history of hypersensitivity to the study drug or its ingredients
more than 5% weight loss in the last 3 months
Pregnant or breastfeeding women
Subject (male, female or intersexual) is not willing to use highly effective contraceptive 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.
Current participation in other interventional clinical trials or treatment with other IMPs within five times the half-life of the drug
Previous therapy with dapagliflozin or other drugs that can potentially lead to overlapping toxicities within five times the half-life of the drug
Patients who do not want to be informed about accidental findings
Any other clinical condition that would jeopardize subjects' safety or well-being while participating in this clinical trial
Patients will not be included in the study if, in the opinion of the investigator, participation leads to an unacceptable risk to their safety and well-being
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Birkenfeld, Prof. Dr. | Contact | 0049707129 | 83670 | andreas.birkenfeld@med.uni-tuebingen.de |
| Andreas Fritsche, Prof. Dr. | Contact | 0049707129 | 80590 | andreas.fritsche@med.uni-tuebingen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Universitätsmedizin Berlin, Klinik für Endokrinologie und Stoffwechselmedizin | Recruiting | Berlin | Germany |
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Randomization will be performed stratified by prediabetes cluster.
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| Placebo matching Dapaglifolzin | Drug | Placebo matching Dapaglifolzin once daily for 6 months. Route of administration: oral. |
|
| Lifestyle Intervention | Behavioral | 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). |
|
To test differences between the two treatment arms for reduction in estimated glomerular filtration rate (eGFR).
| 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). | 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 | 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 | 12 months |
| 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 | 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. | 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. | 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. | 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. | 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. | 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. | 6 months, 12 months |
| Arterial blood pressure | Baseline-adjusted arterial blood pressure at EoT | 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 | 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) | 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. | 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. | 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). | 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). | 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 | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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). | 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 | 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 | 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 6 months, 12 months |
| Changes in risk preferences | To test differences between the two treatment arms for the risk preferences | 6 months, 12 months |
| Changes in time preferences | To test differences between the two treatment arms for the time preferences | 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. | 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 | 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 | 6 months |
| Universitätsstudienzentrum für Stoffwechselerkrankungen , Medizinische Klinik und Poliklinik III | Recruiting | Dresden | Germany |
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| German Diabetes Center, Leibniz-Center for Diabetes Research at the Heinrich-Heine-University Duesseldorf | Recruiting | Düsseldorf | 40225 | Germany |
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| Heidelberg University Hospital - Department of Endocrinology and Metabolism | Recruiting | Heidelberg | 69120 | Germany |
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| Medizinische Klinik und Poliklinik III - Bereich Endokrinologie | Recruiting | Leipzig | Germany |
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| Medizinische Klinik I, UKSH Campus LübeckAG Meyhöfer - Endocrinology, Diabetes & Metabolism | Not yet recruiting | Lübeck | 23562 | Germany |
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| Diabetes Center Med. Klinik und Poliklinik IV, Klinikum der Universität München, LMU | Recruiting | München | Germany |
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| Institut für Ernährungsmedizin, Technische Universität München | Not yet recruiting | München | Germany |
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| University Hospital Tuebingen, Otfried-Mueller Str. 10 | Recruiting | Tübingen | 72076 | Germany |
|
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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