The effect of Alogliptin in the prevention of Type 1 Diabetes Mellitus

Phase 2

• Conditions: Type 1 Diabetes mellitus; C18.452.394.750

• Registration Number: RBR-723bk5p
• Lead Sponsor: niversidade Federal do Ceará

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-23
• Last Update Posted: 29 May 2023
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients of both sexes aged between 18 and 35 years; Confirmed diagnosis of stage 2 autoimmune diabetes mellitus through the presence of 1 or more positive pancreatic islet autoantibodies anti-insulin antibodies, anti-GAD, IA-2, anti-ZnT8A associated with 2 blood glucose values fasting glucose between 100-124 mg/dL or 2 glycated hemoglobin values between 5.7%-6.4% or a fasting glucose between 100-124 mg/dL + 1 glycated hemoglobin value between 5.7%-6.4%

Exclusion Criteria

Pregnant women, breast-feeding women or those who wish to conceive in the last 3 months; Patients with a clinical-laboratory diagnosis of diabetes; Patients on insulin therapy or any other hypoglycemic therapy at the time of inclusion; chronic kidney failure carriers

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess whether the use of alogliptin 25mg/day in patients with stage 2 type 1 diabetes mellitus reduces the rate of progression to stage 3 at the end of 24 months of follow-up when compared to a control group.

Secondary Outcome Measures

Name	Time	Method
In addition to the key outcome, it is expected to compare the following intermediate outcomes between the two groups: A1c, fasting blood glucose and every 30 minutes during 2-hour oral glucose tolerance test; fasting and C-peptide levels at 120 minutes. We will monitor fasting blood glucose, A1c and fasting C-peptide levels every 3 months. Glucose, C-peptide and 25-hydroxyvitamin D levels will be monitored every 6 months. For patients progressing to stage 3, we will assess the dose of exogenous insulin requirement, IDAA1c, and incidence of diabetic ketoacidosis.