Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06217302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2024-01-09
Brief Title:
Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease
Sponsor:
Alessandro Doria
Organization:
Joslin Diabetes Center
Study Overview
Official Title:
Effectiveness and Safety of Sotagliflozin in Slowing Kidney Function Decline in Persons With Type 1 Diabetes and Moderate to Severe Diabetic Kidney Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUGARNSALT
Brief Summary:
Powerful new drugs that can prevent or delay end stage kidney disease ESKD - so called sodium-glucose cotransporter-2 inhibitors SGLT2i - are now available for patients with type 2 diabetes Whether these drugs have similar effects in patients with type 1 diabetes T1D remains unknown because of the few studies in this population due to concerns about the increase in risk of diabetic ketoacidosis DKA a serious potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies observed with SGLT2i therapy in T1D One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin SOTA to very low levels In the present study a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD After a 2-month period during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented eligible study subjects will be randomly assigned 5050 to take one tablet of SOTA 200 mg or a similarly looking inactive tablet placebo every day for 3 years followed by 2-months without treatment Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet The DKA prevention program will include participant education close follow-up with study staff continuous glucose monitoring and systematic ketone body self-monitoring with a meter provided by the study If successful this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD
Detailed Description:
Despite improvements in glycemia management and the use of renin-angiotensin system blockade RASB the overall incidence of ESKD incidence in the US T1D population is not decreasing For patients with type 2 diabetes T2D powerful new drugs that can prevent or delay ESKD sodium-glucose cotransporter-2 inhibitors SGLT2i are now available Whether similar results can be achieved in T1D remains unknown because of the paucity of studies in this population due to concerns about the 2- to 3-fold increase in risk of diabetic ketoacidosis DKA associated with SGLT2i therapy in T1D One of the few T1D studies conducted to date inTandem a sotagliflozin SOTA trial showed that implementation of an enhanced DKA risk monitoring and mitigation strategy can reduce DKA incidence to 1year in subjects on 200 mgday of this dual SGLT1 and SGLT2 inhibitor The goals of the present study are to evaluate the renal effectiveness of SGLT2i in T1D and to better understand the benefitrisk ratio of SOTA in T1D persons with moderate to advanced diabetic kidney disease DKD - two goals that are warranted and critical given the high risk of death and ESKD in this population The study carried out by the Preventing Early Renal Loss PERL and the Canadian Institute of Health Research CIHR-funded SUGARNSALT SS consortia is a multi-center double-blind placebo-controlled parallel-group randomized clinical trial in 150 patients with T1D and moderate to advanced diabetic kidney disease estimated glomerular filtration rate eGFR 20-60 mlmin173 m2 and ACR200 mgg After a 2-month run-in period during which diabetes care is standardized and education on monitoring and minimizing DKA implemented eligible study subjects are randomized in a 11 ratio to receive placebo or once daily 200 mg SOTA for 3 years followed by a 2-month wash-out period The eGFR at the end of the wash-out adjusted by its baseline value will be used as the primary outcome on which SOTA efficacy on DKD progression will be evaluated An intensive DKA risk mitigation plan will be implemented based on the inTandem enhanced protocol as well as on the STICH Stop SGLT2i Insulin administration Carbohydrate intake Hydration and STOP-DKA protocols Cornerstones of this plan will be enhanced participant education close follow-up with study staff continuous glucose monitoring and systematic ketone body beta-hydroxybutyrate BHB self-monitoring If successful the present study will provide efficacy and safety data that could be used to seek FDA and Health Canada approval of SOTA for a T1D DKD indication Based on the available data in T1D it can be conservatively postulated that SOTA may reduce eGFR loss by 2 mlmin173 m2 per year Depending on the baseline eGFR this would translate to a 5-10 year delay of ESKD The reduction in morbidity and mortality resulting from the prevention or delay of ESKD due to the use of SOTA would have a major impact on the lives of T1D patients with significant DKD as well as on society at large substantially reducing the human and financial costs associated with this condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None