Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630585
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
GIPGLP-1RA as Adjunctive to Automated Insulin Delivery in Adults With Type 1 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
GIPGLP-1RA as Adjunctive to Automated Insulin Delivery in Adults With Type 1 Diabetes A Prospective Randomized Clinical Study - The AID-JUNCT Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
AID-JUNCT
Brief Summary:
Blood glucose management in type 1 diabetes T1D remains a challenge with only 30 of adults within the recommended consensus guidelines Novel drugs like glucagon-like peptide-1 receptor agonists GLP-1RAs and glucose-dependent insulinotropic polypeptide GIPGLP-1RAs have emerged as promising add-ons to insulin in T1D
This application has been designed to test in a prospective study whether adding a new medicine called tirzepatide GIPGLP-1RA to the usual insulin therapy would make a difference for people with T1D in terms of better glucose control
This application has been designed to test in a prospective study whether adding a new medicine called tirzepatide GIPGLP-1RA to the usual insulin therapy would make a difference for people with T1D in terms of better glucose control
Detailed Description:
Glycemic control in type 1 diabetes T1D remains a challenge with 30 of adults achieving an A1c target of 7 The glucagon-like peptide-1 receptor agonists GLP-1RAs and glucose-dependent insulinotropic polypeptide GIPGLP-1RAs have emerged as a promising therapy in T1D Retrospective studies have shown patients with T1D can significantly improve glycemic control with a reduction in insulin dose and body weight when long-acting GLP-1RAs or GIPGLP-1RAs are added to insulin therapy However randomized controlled trials RCT are still lacking
This is a prospective randomized open-label design The investigators will enroll 42 participants over 18 years of age with confirmed T1D diagnosis 6 months currently on automatic insulin delivery AID therapy for at least three months with A1C 65 and 10and BMI 23 kgm2 Participants will be randomized in a 11 ratio to either tirzepatide 50 mg or continue with the Standard of Care SoC for 12 weeks after a titration phase with the lowest dose of 25 mg The primary endpoint is continuous glucose monitoring CGM percent time spent between 39 and 100 mmolL TIR from baseline to follow-up after 12 weeks of treatment Secondary endpoints include the change in 247 CGM percent time ampgt100 mmolL 247 CGM percent time ampgt139 mmolL 247 CGM percent time amplt39 mmolL 247 CGM percent time amplt30 mmolL and the change in body mass index BMI
This is the first prospective study to investigate the efficacy and safety of tirzepatide GIPGLP1-RAs as an adjuvant therapy to AID This study may contribute unique data to significantly improving glucose outcomes reducing the T1D burden improving the quality of life and re-directing attention to further treatment in T1D beyond insulin therapies
This is a prospective randomized open-label design The investigators will enroll 42 participants over 18 years of age with confirmed T1D diagnosis 6 months currently on automatic insulin delivery AID therapy for at least three months with A1C 65 and 10and BMI 23 kgm2 Participants will be randomized in a 11 ratio to either tirzepatide 50 mg or continue with the Standard of Care SoC for 12 weeks after a titration phase with the lowest dose of 25 mg The primary endpoint is continuous glucose monitoring CGM percent time spent between 39 and 100 mmolL TIR from baseline to follow-up after 12 weeks of treatment Secondary endpoints include the change in 247 CGM percent time ampgt100 mmolL 247 CGM percent time ampgt139 mmolL 247 CGM percent time amplt39 mmolL 247 CGM percent time amplt30 mmolL and the change in body mass index BMI
This is the first prospective study to investigate the efficacy and safety of tirzepatide GIPGLP1-RAs as an adjuvant therapy to AID This study may contribute unique data to significantly improving glucose outcomes reducing the T1D burden improving the quality of life and re-directing attention to further treatment in T1D beyond insulin therapies
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