Fig 1.
SPIRIT Schedule of Enrolment, Interventions, and Assessments.
Abbreviations: BMI = body mass index; BG = blood glucose; BP = blood pressure; HR = heart rate; BIA = bioelectrical impedance analysis; CGM = continuous glucose monitoring; DTSQs-c = diabetes treatment satisfaction questionnaire status and change versions; ECG = electrocardiogram; U/S = unscheduled; P/D = premature discontinuation; DKA = diabetes ketoacidosis; HbA1c = hemoglobin A1c; Hb = hemoglobin; HCT = hematocrit; IMP = investigational medicinal product (study drug); FDA = Food and Drug Administration. aOnly for the participants in the intervention arm. bIncluded: gender, race/ethnicity, and year of birth. cThe temperature should be measured at the screening visit (V1) and randomization visit (V2) to exclude infection. dA serum pregnancy test will be performed at the screening visit, the result must be available before randomization and the first injection of the study drug for women of childbearing potential only. Additional pregnancy in urine tests will be repeated during the study eInclude: total bilirubin, direct bilirubin, alkaline phosphatase (ALP), partial thromboplastin time (PTT), prothrombin time (PT), international normalized ratio (INR), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT). fInclude: total bilirubin, direct bilirubin, ALT, AST. gInclude: thyroid-stimulating hormone (TSH), free thyroxine (FT4), calcitonin, C-peptide (fasting), estradiol, and follicle-stimulating hormone (FSH). hOnly calcitonin. iInclude: creatinine (with eGFR by CKD-EPI), and urine microalbumin/creatinine ratio (uACR). jOnly creatinine (with eGFR by CKD-EPI).
Fig 2.
Schematic representation of the overall study design, including run-in period, randomization, intervention, and follow-up periods.
Fig 3.
Flowchart of participant progression through the trial, showing screening, randomization, allocation, follow-up, and analysis.