Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180616
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-11-21
Brief Title:
Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity
Sponsor:
Royal North Shore Hospital
Organization:
Royal North Shore Hospital
Study Overview
Official Title:
Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity A Placebo-Matched Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
TZP-T1D
Brief Summary:
This study is a 2-arm double blinded randomised clinical trial where 40 participants will be assigned 11 to insulin treatment alone control or insulin treatment and tirzepatide treatment for 32 weeks The primary objective is to demonstrate that tirzepatide treatment dose incremented to 15mg QW for 32 weeks adjunctive to insulin treatment can reduce body weight in patients with T1D and overweight or obesity when compared to insulin treatment alone The secondary objective is to demonstrate that tirzepatide treatment dose incremented to 15mg QW for 32 weeks can improve glycaemic control measured by hbA1c improve time in range reduce insulin requirements and reduce the severity of comorbidities in people with obesity and T1D This trial includes a 6 month follow-up period
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None