Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04620590
Status:
UNKNOWN
Last Update Posted:
2021-09-08
First Post:
2020-11-03
Brief Title:
An Open Label Phase IV Study to Evaluate Dapagliflozin Treatment in Type 2 Diabetes Mellitus Patients With Impaired Renal Function
Sponsor:
George Clinical Pty Ltd
Organization:
George Clinical Pty Ltd
Study Overview
Official Title:
DAPASALT An Open Label Phase IV Mechanistic Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin Treatment in Type 2 Diabetes Mellitus Patients With Impaired Renal Function
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Open label mechanistic single-arm study to evaluate the natriuretic effect of 2 weeks dapagliflozin treatment in T2DM patients with impaired renal function It will measure the average change in 24-hr sodium excretion from average Baseline to average values at Day 2 to 4 within the study group The study will allow for an up to 6-week Screening and Run-in Period a 2-week Treatment Period and a 5-day Follow-up Period Patients will consume food from standardized food boxes starting on Day -6 patients not on insulin or Day -20 at the earliest patients on insulin of the study until Day 18 inclusive Eligible patients will receive dapagliflozin 10 mg tablets once daily for 141 days starting on Day 1 This will be followed by a Follow-up Period of 5 days
Detailed Description:
This is an open label mechanistic single-arm study to evaluate the natriuretic effect of 2 weeks dapagliflozin treatment in T2DM patients with impaired renal function The study population is as described below The maximum duration of the study will be 62 days including the allowed window periods for the study 1 day for Visit 7 at Day 13 The study will allow for an up to 6-week Screening and Run-in Period The Run-in Period should always last 6 days for patients not on insulin but may be up to 20 days day -20 to day -1 for patients on insulin Patients on insulin may require a longer Run-in Period in order to be able to adjust their insulin requirements according to the caloric content of the food boxes if needed It is recommended to keep the insulin dose stable during the trial but investigators can change the dose if medically required However it is not mandatory for the patient on insulin to use the entire extended Run-in Period Based on the Investigators judgement the Run-in Period may be shortened once each patient on insulin has had sufficient time to adapt to the food boxes and it is determined that the patients insulin requirement has stabilised sufficiently to continue in the study The study will then include a 2-week Treatment Period Day 1 to Day 14 and a 5-day Follow-up Period Day 15 to Day 19 Patients will consume food from standardised food boxes with sodium content 150 mmol starting on Day -6 patients not on insulin or Day -20 at the earliest patients on insulin of the study until Day 18 inclusive Eligible patients will receive dapagliflozin 10 mg tablets once daily for 141 days starting on Day 1 This will be followed by a Follow-up Period of 5 days
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HC6-24-c243179 | OTHER | Health Canada | None |
| 2020-001247-12 | EUDRACT_NUMBER | None | None |