Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4201
Source ID: NCT06180616
Associated Drug: Tirzepatide
Title: Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity
Acronym: TZP-T1D
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus|Overweight and Obesity
Interventions: DRUG: Tirzepatide
Outcome Measures: Primary: Body weight, Percent body weight change (%), 32 weeks | Secondary: hbA1c, Change in hbA1c levels (%), 32 weeks|Time in range, Change in continuous glucose monitoring (CGM) metrics (time in range (3.9-10mmol/L)), 32 weeks|Total daily insulin dose, Change in insulin dose (total daily dose, units/kg of body weight), 32 weeks|Insulin carbohydrate ratio, Change in insulin dose (insulin carbohydrate ratio (units per g)), 32 weeks|Waist and neck circumference, Change in waist and neck circumference, 32 weeks|Blood pressure, Change in blood pressure, 32 weeks|Mean glucose, Change in continuous glucose monitoring (CGM) metrics (mean glucose), 32 weeks|Time in hypoglycaemia, Change in continuous glucose monitoring (CGM) metrics (time in hypoglycaemia (mild \< 3.9, severe \< 2.5mmol/L)), 32 weeks|Time in hyperglycaemia, Change in continuous glucose monitoring (CGM) metrics (time in hyperglycaemia (mild \>10, severe 13.9mmol/L)), 32 weeks|Continuous glucose monitoring, Change in continuous glucose monitoring (CGM) metrics (SD), 32 weeks|Continuous glucose monitoring, Change in continuous glucose monitoring (CGM) metrics (CV), 32 weeks|Continuous glucose monitoring, Change in continuous glucose monitoring (CGM) metrics (CONGA), 32 weeks|Continuous glucose monitoring, Change in continuous glucose monitoring (CGM) metrics (J-index), 32 weeks|Continuous glucose monitoring, Change in continuous glucose monitoring (CGM) metrics (MAGE), 32 weeks|Total cholesterol, Change in lipid parameters (total cholesterol), 32 weeks|Triglyceride, Change in lipid parameters (triglyceride), 32 weeks|LDL-C, Change in lipid parameters (LDL-C), 32 weeks|HDL-C, Change in lipid parameters (HDL-C), 32 weeks|ACR, Change in albumin to creatinine ratio (ACR), 32 weeks|eGFR, Change in renal function (eGFR), 32 weeks|HSI, Change in NAFLD biomarker HSI. Hepatic steatosis defined as HSI \> 36, 32 weeks|FIB-4, Change in NAFLD biomarker FIB-4. Hepatic steatosis defined as FIB-4 index ≥ 1.3 or \< 1.3, 32 weeks|Brachial-Ankle Pulse Wave Velocity using Ankle Brachial Index Machine, Change in Brachial-Ankle Pulse Wave Velocity (baPWV), 32 weeks|Arterial Stiffness using a Pulse Wave Tonometer, Change in arterial stiffness, 32 weeks|Aortic Stiffness using a Pulse Wave Tonometer, Change in aortic stiffness, 32 weeks|Left Ventricular Strain using Electrocardiogram, Change in left ventricular strain, 32 weeks
Sponsor/Collaborators: Sponsor: Royal North Shore Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2026-04
Results First Posted:
Last Update Posted: 2024-06-03
Locations:
URL: https://clinicaltrials.gov/show/NCT06180616