Trial · NCT07460336
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in 2-hour Mixed-Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC) | Baseline, Week 52 | Change from baseline in the area under the curve from 0 to 120 minutes (AUC0-120) for serum C-peptide during a mixed-meal tolerance test (MMTT), calculated using the trapezoidal rule from C-peptide measured at 0, 60, and 120 minutes. |
| Secondary | Change From Baseline in 2-hour MMTT C-peptide AUC at Weeks 12, 26, and 38 | Baseline, Week 12, Week 26, Week 38 | The 2-hour Mixed-Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC) will be calculated using the trapezoidal rule from C-peptide levels measured at 0, 60, and 120 minutes during the MMTT. Change from baseline is defined as the post-baseline value minus the baseline value. This outcome assesses the overall C-peptide response to a standardized meal stimulus. |
| Secondary | Change From Baseline in Fasting C-peptide (FCP) | Baseline, Week 12, Week 26, Week 38, Week 52 | Fasting C-peptide (FCP) is measured from a blood sample taken after an overnight fast of at least 8 hours. It reflects the basal insulin secretion capacity of pancreatic β-cells. |
| Secondary | Change From Baseline in 60-Minute Post-Meal C-peptide | Baseline, Week 12, Week 26, Week 38, Week 52 | Serum C-peptide will be measured at 60 minutes during the mixed-meal tolerance test (MMTT). Change from baseline is defined as the post-baseline 60-minute C-peptide value minus the baseline 60-minute C-peptide value. This measurement assesses the early dynamic response of pancreatic β-cells to a meal stimulus. |
| Secondary | Change From Baseline in 120-Minute Post-Meal C-peptide | Baseline, Week 12, Week 26, Week 38, Week 52 | Serum C-peptide will be measured at 120 minutes during the mixed-meal tolerance test (MMTT). Change from baseline is defined as the post-baseline 120-minute C-peptide value minus the baseline 120-minute C-peptide value. This measurement assesses the late dynamic response of pancreatic β-cells to a meal stimulus. |
| Secondary | Change From Baseline in Glycated Hemoglobin (HbA1c) | Baseline, Week 26, Week 52 | HbA1c provides an indication of the average blood glucose levels over the preceding 2-3 months. This outcome measures the long-term glycemic control in participants. |
| Secondary | Proportion of Participants Achieving HbA1c < 7.0% | Week 12, Week 26, Week 38, Week 52 | The percentage of participants in each group who achieve a target HbA1c level of less than 7.0% (53 mmol/mol), which is a standard therapeutic goal for glycemic control in adults with diabetes. |
| Secondary | Change From Baseline in Mean Daily Insulin Dose | Baseline, Week 12, Week 26, Week 38, Week 52 | The change from baseline in the mean daily insulindose will be calculated as units per kilogram per day (u/kg/day), based on data recorded in participant diaries. This outcome is designed to evaluate the effect of the intervention on the requirement for exogenous insulin. |
| Secondary | Change From Baseline in Homeostatic Model Assessment of β-cell function (HOMA-β) | Baseline, Week 12, Week 26, Week 38, Week 52 | HOMA-β is calculated using fasting glucose and fasting C-peptide levels. It provides an estimate of basal pancreatic β-cell function. Change from baseline is defined as the post-baseline value minus the baseline value. |
| Secondary | Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline, Week 12, Week 26, Week 38, Week 52 | HOMA-IR is calculated using fasting glucose and fasting C-peptide levels. It provides an estimate of insulin resistance. Change from baseline is defined as the post-baseline value minus the baseline value. |
| Secondary | Change From Baseline in Glutamic Acid Decarboxylase Autoantibody (GADA) Titers | Baseline, Week 52 | GADA is a marker of the autoimmune process in LADA. Change from baseline is defined as the Week 52 value minus the baseline value. Changes in its titers may reflect modulation of the autoimmune response. |
| Secondary | Change From Baseline in Insulinoma-Associated Antigen-2 Autoantibody (IA-2A) Titers | Baseline, Week 52 | IA-2A is a marker of the autoimmune process in LADA. Changes in its titers may reflect modulation of the autoimmune response. Change from baseline is defined as the Week 52 value minus the baseline value. |
| Secondary | Change From Baseline in Zinc Transporter 8 Autoantibody (ZnT8A) Titers | Baseline, Week 52 | ZnT8A is a marker of the autoimmune process in LADA. Changes in its titers may reflect modulation of the autoimmune response. Change from baseline is defined as the Week 52 value minus the baseline value. |
| Secondary | Change From Baseline in Body Weight | Baseline, Week 12, Week 26, Week 38, Week 52 | Body weight will be measured in kilograms (kg) at scheduled visits. Change from baseline is defined as the post-baseline value minus the baseline value. |
| Secondary | Change From Baseline in Body Mass Index (BMI) | Baseline, Week 12, Week 26, Week 38, Week 52 | Body Mass Index (BMI) will be calculated as weight in kilograms divided by the square of height in meters (kg/m²) to assess changes in body composition. Change from baseline is defined as the post-baseline value minus the baseline value. |
| Other | Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Throughout the study (52 weeks) | Safety will be evaluated by recording the number of participants who experience treatment-emergent adverse events and serious adverse events throughout the study, including events of special interest such as severe hypoglycemia and potential hypercalcemia. |
| Other | Number of participants with Clinically Significant Abnormal Vital Signs, Laboratory Tests, or ECG Findings | At scheduled visits through Week 52 | Safety will be monitored by assessing the number (and proportion) of participants who experience clinically significant changes from baseline in vital signs (systolic and diastolic blood pressure, heart rate, body temperature), clinical laboratory parameters (hematology, clinical chemistry, and urinalysis), or 12-lead electrocardiogram (ECG) findings. Clinically significant changes will be evaluated by the investigator. Each participant will be counted once if any qualifying abnormality occurs. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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