Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532682
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Efficacy of Dapagliflozin in Early Diabetic Nephropathy in Type 1 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Mechanism of Dapagliflozin Combined With Insulin in the Treatment of Early Diabetic Nephropathy in Patients With Type 1 Diabetes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetic kidney disease DKD is a leading cause of chronic and end-stage kidney disease affecting 25-40 of type 1 diabetes T1D patients and 5-40 of type 2 diabetes T2D patients Despite standard treatments like ACE inhibitors and ARBs many patients continue to develop DKD indicating a need for better kidney protection This study aims to evaluate the efficacy and safety of dapagliflozin combined with insulin in early DKD patients with T1DM using ACEiARB as standard treatment to provide new insights into kidney protection and support precision medicine goals
Detailed Description:
This is an open-label randomized parallel-group study to evaluate the effects of dapagliflozin on urinary albumincreatinine ratio UACR in participants with early diabetic nephropathy and type 1 diabetes mellitus T1DM The primary objective is to assess the changes in UACR and estimated glomerular filtration rate eGFR before and after dapagliflozin treatment in these patients Secondary objectives include observing blood glucose control weight improvement and safety evaluation after dapagliflozin treatment
The study comprises three groups dapagliflozin 10 mg dapagliflozin 5 mg and a standard treatment control with a 111 allocation ratio Participants meeting the inclusion criteria and not meeting any exclusion criteria will enter a 4-8 week lead-in period during which they will receive the maximum tolerable dose of ACEIARB medications maintain this treatment for at least 4 weeks and optimize blood glucose control under the guidance of medical professionals while wearing continuous glucose monitoring devices Starting from baseline participants will receive either dapagliflozin 5 mg or 10 mg once daily for 24 weeks while the control group will continue on the maximum tolerable dose of ACEIARB medications Continuous glucose monitoring and regular ketone monitoring will be performed to prevent diabetic ketoacidosis Follow-up visits will occur approximately 30 days after the last dose of study medication or upon study completion
The primary efficacy indicators are the mean changes in UACR and eGFR from baseline to week 24 Secondary efficacy indicators include changes in 24-hour urine biochemistry HbA1c body weight continuous glucose monitoring indices and total daily insulin dose Safety evaluation indicators include adverse events serious adverse events diabetic ketoacidosis severe hypoglycemia and urinary or genital infections
The study comprises three groups dapagliflozin 10 mg dapagliflozin 5 mg and a standard treatment control with a 111 allocation ratio Participants meeting the inclusion criteria and not meeting any exclusion criteria will enter a 4-8 week lead-in period during which they will receive the maximum tolerable dose of ACEIARB medications maintain this treatment for at least 4 weeks and optimize blood glucose control under the guidance of medical professionals while wearing continuous glucose monitoring devices Starting from baseline participants will receive either dapagliflozin 5 mg or 10 mg once daily for 24 weeks while the control group will continue on the maximum tolerable dose of ACEIARB medications Continuous glucose monitoring and regular ketone monitoring will be performed to prevent diabetic ketoacidosis Follow-up visits will occur approximately 30 days after the last dose of study medication or upon study completion
The primary efficacy indicators are the mean changes in UACR and eGFR from baseline to week 24 Secondary efficacy indicators include changes in 24-hour urine biochemistry HbA1c body weight continuous glucose monitoring indices and total daily insulin dose Safety evaluation indicators include adverse events serious adverse events diabetic ketoacidosis severe hypoglycemia and urinary or genital infections
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None