Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 4:30 PM
Study NCT ID:
NCT05696366
Status:
RECRUITING
Last Update Posted:
2024-11-04
First Post:
2023-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes
Status:
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:
SOTA
Brief Summary:
This is a single site, double-blind, placebo-controlled, crossover trial to quantify the effects of combination adjunctive therapy on glycemic control, ketogenesis during insulinopenia, insulin resistance, and diabetes burden and quality of life.
Detailed Description:
This is a single site, double-blind, placebo-controlled, crossover trial to quantify the effects of combination adjunctive therapy on glycemic control, ketogenesis during insulinopenia, insulin resistance, and diabetes burden and quality of life.
Up to 22 adult participants with type 1 diabetes (T1D) will be enrolled with at least 16 participants completing the study in full. After screening, baseline data (A1c, CGM, ambulatory insulin dosing, ambulatory ketones \[fasting and after infusion set change\], and psychosocial questionnaires) will be collected and participants will complete an insulin withdrawal test (IWT) and a hyperinsulinemic-euglycemic clamp (HEC) with indirect calorimetry (IDC). Participants will then receive 12-week insulin-adjunctive treatments with both: (1) SGLTi (sotagliflozin 200 mg daily) + Placebo and (2) SGLTi + GRA (volagidemab 35 mg weekly), in a random-order, cross-over design with a 14-week washout period between treatment periods. Throughout the treatment periods subjects will be seen weekly in clinic for medication dosing (GRA or placebo) and download/review of CGM, insulin, and ketone data. At the end of each treatment period, the baseline studies will be repeated. Subjects will return for a safety follow up visit 6 weeks after the final GRA or placebo dose.
Up to 22 adult participants with type 1 diabetes (T1D) will be enrolled with at least 16 participants completing the study in full. After screening, baseline data (A1c, CGM, ambulatory insulin dosing, ambulatory ketones \[fasting and after infusion set change\], and psychosocial questionnaires) will be collected and participants will complete an insulin withdrawal test (IWT) and a hyperinsulinemic-euglycemic clamp (HEC) with indirect calorimetry (IDC). Participants will then receive 12-week insulin-adjunctive treatments with both: (1) SGLTi (sotagliflozin 200 mg daily) + Placebo and (2) SGLTi + GRA (volagidemab 35 mg weekly), in a random-order, cross-over design with a 14-week washout period between treatment periods. Throughout the treatment periods subjects will be seen weekly in clinic for medication dosing (GRA or placebo) and download/review of CGM, insulin, and ketone data. At the end of each treatment period, the baseline studies will be repeated. Subjects will return for a safety follow up visit 6 weeks after the final GRA or placebo dose.
Study Oversight
Has Oversight DMC:
False
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?: