Pharmacokinetics (PK) and pharmacodynamics (PD) study of InsuBiomm R (Regular Insulin) in comparison to Humulin R in Type 1 patients

Phase 1

• Conditions: Type 1 diabetes mellitus; C18.452.394.750.124

• Registration Number: RBR-7mvgfc
• Lead Sponsor: Instituto de Ciências Farmacêuticas de Estudos e Pesquisas Ltda.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Be between 18 and 65 years old, inclusive;have been diagnosed with type 1 diabetes for at least 1 year;body Mass Index (BMI) between 18 and 30 kg / m2;being on insulin therapy;have basic knowledge of the disease that allows self-adjustment of the insulin dose according to the algorithm described in the protocol;h have positive anti-GAD antibody or anti-IA2 antibody positive or C-peptide levels less than 0.5ng / mL (0.2 mmol / L);participants should be free of any detectable micro- and macroangiopathic complications that are clinically significant at the discretion of the investigator and any major disease other than diabetes as indicated by medical history, physical examination, electrocardiogram, or routine laboratory exams

Exclusion Criteria

Type 2 diabetes;use of any oral hypoglycemic;any factor that opposes the inclusion criteria; pregnant or lactating women who are breastfeeding; participants in the use of glucocorticoids or any other medication that may interfere with glycemic control, at the discretion of the investigator; any concomitant medical condition that may interfere with the performance of the protocol, including but not limited to clamp; participant with chronic hepatopathy, chronic renal failure, renal insufficiency, congestive heart failure grade II or above; history of cancer in the last 5 years;participant with indication for any surgical procedure in the next 6 months;h history of major surgery in the last 6 months.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objective: To compare pharmacokinetics (PK) and pharmacodynamics (PD) of two recombinant human Regular insulins: Regular Human Insulin (BIOMM S.A / Bioton) vs Humulin R (Eli Lilly Brasil Ltda) in type 1 diabetic patients (T1DM).<br><br>Primary outcomes:<br>Pharmacokinetic parameters (PK): AUCins.0-12h e Cins.max.<br>Pharmacodynamic parameters (PD): AUCTIG0-T e TIGmax.<br><br><br>;Pharmacokinetic parameters (PK): T1/2; AUCins.0-4h, AUCins.0-6h; AUCins.6-12h, AUCins.6h-infinite, Tmax;<br>Pharmacodynamic parameters (PD): AUCTIG0-4, AUCTIG0-6h; AUCTIG6-T, duration of action;<br>TTIGmax.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary objectives: To assess local safety and tolerability after single dose of two recombinant human regular insulins: regular human insulin (BIOMM S.A / Bioton) compared to Humulin R (Eli Lilly Brasil Ltda.) in type 1 diabetic patients (T1DM).<br><br>Safety parameters: Adverse events, laboratory tests, physical examination, vital signs, tolerability at the site of insulin application and electrocardiogram. For these parameters will be presented the descriptive statistics of each parameter.<br><br><br>