Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06054035

SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Type2diabetes Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases PreDiabetes Prediabetic State Renal Failure Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Charité Universitätsmedizin Berlin, Klinik für Endokrinologie und Stoffwechselmedizin, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male, female or intersexualpatients aged between 35 and 75 years (including)
  • Prediabetes (defined by one of the following: FG ≥ 100 mg/dL or 2h OGTT glucose ≥ 140 mg/dL)
  • BMI ≥20 kg/m2
  • TSH within normal range
  • Ability to understand and follow study-related instructions
  • Negative pregnancy test for premenopausal women (blood)
  • Patients who are receiving thyroid replacement therapy must be on a stable treatment regimen for at least 3 months prior to the screening visit (V-1)
  • Patients who are receiving antihypertensive medication such as mineralocorticoid receptor antagonists must be on a stable treatment regimen for at least 6 weeks prior to the screening visit (V-1)
  • Patients who are treated antihypertensive medication such as ACE inhibitors and AT1receptor antagonists, thiazides as well as loop diuretics must be on stable treatment for at least 2 weeks
  • Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
  • Patients will not be included in the study if, in the opinion of the investigator participation will lead to an unacceptable risk to the subjects' safety or well-being

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

Treatment and study plan

Dapagliflozin (Forxiga®)

Drug

Dapagliflozin 10 mg once daily for 6 months. Route of administration: oral.

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).

Primary outcomes

  1. Frequency of remission of hyperglycemia

    Time frame: 6 months

    Frequency of individuals with prediabetes remission (normalization of fasting and 2h glucose concentrations) with dapagliflozin in comparison to treatment with placebo.

Secondary outcomes

  1. Reduction of urinary albumine-creatinine ratio.

    Time frame: 1 month throuhg 6 months

    To test differences between the two treatment arms for reduction of urinary albumine-creatinine ratio.

  2. Change in estimated glomerular filtration rate (eGFR)

    Time frame: 7 months

    To test differences between the two treatment arms for reduction in estimated glomerular filtration rate (eGFR).

  3. 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

    To test differences between the two treatment arms for slopes over time of estimated glomerular filtration rate (eGFR).

  4. Numbers of patients showing resolution of chronic kidney disease (CKD)

    Time frame: 3 months through 12 months

    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

  5. Prediabetes remission maintenance

    Time frame: 12 months

    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

Other outcomes

  1. Insulin sensitivity

    Time frame: 6 months, 12 months

    Baseline-adjusted insulin sensitivity at EoT using Insulin sensitivity: ISI-Matsuda/Oral glucose insulin sensitivity index.

  2. Insulin secretion

    Time frame: 6 months, 12 months

    Baseline-adjusted insulin secretion at EoT using an estimate for insulin secretion: C-peptide0-30AUC/glucose0-30AUC.

  3. Number of patients progressing to Type 2 Diabetes

    Time frame: 6 months, 12 months

    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

  4. Change in body weight

    Time frame: 6 months, 12 months

    Effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on change in body weight.

  5. Change in BMI

    Time frame: 6 months, 12 months

    Effects of 6 months treatment with dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on BMI.

  6. Change in whole body fat

    Time frame: 6 months, 12 months

    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.

  7. Change in visceral fat

    Time frame: 6 months, 12 months

    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.

  8. Change in liver fat

    Time frame: 6 months, 12 months

    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.

  9. Change in subcutaneous fat

    Time frame: 6 months, 12 months

    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.

  10. Arterial blood pressure

    Time frame: 6 months, 7 months, 12 months

    Baseline-adjusted arterial blood pressure at EoT

  11. New onset or progress of neuropathy

    Time frame: 6 months, 12 months

    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

  12. Quality of life using the Short Form Health Survey (SF)-36 questionnaire

    Time frame: 6 months, 12 months

    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)

  13. Interaction between diabetes risk cluster and intervention for numbers of patients showing a resolution of Prediabetes

    Time frame: 6 months, 12 months

    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.

  14. Interaction between diabetes risk cluster and intervention for change in albuminuria

    Time frame: 6 months, 12 months

    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.

  15. Interaction between diabetes risk cluster and intervention for change in estimated glomerular filtration rate (eGFR).

    Time frame: 6 months, 12 months

    To test interaction between diabetes risk clusters and intervention on estimated glomerular filtration rate (eGFR).

  16. Interaction between diabetes risk cluster and intervention for slopes over time of estimated glomerular filtration rate (eGFR).

    Time frame: 4 weeks, 3 months, 6 months, 7 months, 12 months

    To test interaction between diabetes risk clusters and intervention on slopes over time of estimated glomerular filtration rate (eGFR).

  17. Interaction between diabetes risk cluster and intervention for numbers of patients showing resolution of chronic kidney disease (CKD)

    Time frame: 3 months, 6 months, 7 months, 12 months

    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

  18. Interaction between diabetes risk cluster and intervention for insulin sensitivity.

    Time frame: 6 months, 12 months

    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.

  19. Interaction between diabetes risk cluster and intervention for insulin secretion

    Time frame: 6 months, 12 months

    To test interaction between diabetes risk clusters and intervention for baseline-adjusted insulin secretion at EoT using insulin secretion:C-peptide0-30AUC/glucose0-30AUC.

  20. Interaction between diabetes risk cluster and intervention for number of patients progressing to Type 2 Diabetes

    Time frame: 6 months, 12 months

    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

  21. Interaction between diabetes risk cluster and intervention for change in body weight

    Time frame: 6 months, 12 months

    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.

  22. Interaction between diabetes risk cluster and intervention for change in BMI.

    Time frame: 6 months, 12 months

    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.

  23. Interaction between diabetes risk cluster and intervention for change in whole body fat

    Time frame: 6 months, 12 months

    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.

  24. Interaction between diabetes risk cluster and intervention for change in visceral fat

    Time frame: 6 months, 12 months

    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.

  25. Interaction between diabetes risk cluster and intervention for change in liver fat

    Time frame: 6 months, 12 months

    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.

  26. Interaction between diabetes risk cluster and intervention for change in subcutaneous fat

    Time frame: 6 months, 12 months

    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.

  27. Interaction between diabetes risk cluster and intervention for change in arterial blood pressure

    Time frame: 6 months, 7 months, 12 months

    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

  28. Interaction between diabetes risk cluster and intervention on the new onset or progress of neuropathy

    Time frame: 6 months, 12 months

    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.

  29. Interaction between diabetes risk cluster and intervention for change in quality of life

    Time frame: 6 months, 12 months

    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).

  30. Small vessel density

    Time frame: 6 months, 12 months

    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

  31. Interaction between diabetes risk cluster and intervention on small vessel density

    Time frame: 6 months, 12 months

    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

  32. New onset or progress of diabetic retinopathy

    Time frame: 6 months, 12 months

    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

  33. Interaction between diabetes risk cluster and intervention on the new onset or progress of diabetic retinopathy

    Time frame: 6 months, 12 months

    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.

  34. Composition of the gut microbiome

    Time frame: 3 months, 6 months, 7 months, 12 months

    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

  35. Interaction between diabetes risk cluster and intervention for composition of the gut microbiome

    Time frame: 3 months, 6 months, 7 months, 12 months

    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

  36. Urinary metabolite signature of SGLT2 inhibitors

    Time frame: 6 months, 12 months

    Changes in urinary metabolites within and between intervention and placebo groups over time using MS-based metabolomics and machine learning algorithms

  37. Interaction between diabetes risk cluster and intervention for urinary metabolite signature of SGLT2 inhibitors

    Time frame: 6 months, 12 months

    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

  38. Myocardial function shown by left ventricular mass index

    Time frame: 6 months, 12 months

    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

  39. Interaction between diabetes risk cluster and intervention on Myocardial function shown by left ventricular mass index

    Time frame: 6 months, 12 months

    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.

  40. Myocardial function shown by systolic myocardial function

    Time frame: 6 months, 12 months

    Effects of dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on systolic myocardial function assessed via cardiac magnetic resonance imaging.

  41. Interaction between diabetes risk cluster and intervention on Myocardial function shown by systolic myocardial function

    Time frame: 6 months, 12 months

    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.

  42. Myocardial function shown by diastolic myocardial function

    Time frame: 6 months, 12 months

    Effects of dapagliflozin 10 mg and lifestyle counseling compared to placebo and lifestyle intervention on diastolic myocardial function assessed via cardiac magnetic resonance imaging.

  43. Interaction between diabetes risk cluster and intervention on Myocardial function shown by diastolic myocardial function

    Time frame: 6 months, 12 months

    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.

  44. Health economic evaluation shown by incremental cost-effectiveness ratio

    Time frame: 6 months, 12 months

    Conducting a health economic evaluation from the perspective of the statutory health insurance and society in from of a cost-effectiveness analysis

  45. Interaction between diabetes risk cluster and intervention on health economic evaluation shown by incremental cost-effectiveness ratio

    Time frame: 6 months, 12 months

    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

  46. Health economic evaluation shown by incremental cost-utility ratio

    Time frame: 6 months, 12 months

    Conducting a health economic evaluation from the perspective of the statutory health insurance and society in from of a cost-utility analysis

  47. Interaction between diabetes risk cluster and intervention on health economic evaluation shown by incremental cost-utility ratio

    Time frame: 6 months, 12 months

    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

  48. Changes in risk preferences

    Time frame: 6 months, 12 months

    To test differences between the two treatment arms for the risk preferences

  49. Changes in time preferences

    Time frame: 6 months, 12 months

    To test differences between the two treatment arms for the time preferences

  50. Interaction between diabetes risk cluster and intervention on prediabetes remission maintenance

    Time frame: 12 months

    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.

  51. Interaction between diabetes risk cluster and intervention on the risk preferences

    Time frame: 6 months

    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

  52. Interaction between diabetes risk cluster and intervention on the risk preferences

    Time frame: 6 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Birkenfeld, Prof. Dr.

CONTACT

[email protected]

0049707129 ext. 83670

Andreas Fritsche, Prof. Dr.

CONTACT

[email protected]

0049707129 ext. 80590

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • AstraZeneca
  • German Center for Diabetes Research
  • German Federal Ministry of Education and Research

Registry information

Official study title

SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes - a Randomized, Placebo Controlled, Multi-center Trial

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 26, 2023
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.