Type 1 diabetes mellitus
Conditions
Interventions
Phase 1 clinical trial , monocentric, randomized, double blind, 2 treatments crossed-over conducted in 2 periods with 14 (± 7) wash-out days between doses , comparing two recombinant human Regular ins
Biological/vaccine
Sponsors
Instituto de Ciências Farmacêuticas de Estudos e Pesquisas Ltda.
Instituto de Ciências Farmacêuticas de Estudos e Pesquisas Ltda.
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). Primary outcomes: Pharmacokinetic parameters (PK): AUCins.0-12h e Cins.max. Pharmacodynamic parameters (PD): AUCTIG0-T e TIGmax. ;Pharmacokinetic parameters (PK): T1/2; AUCins.0-4h, AUCins.0-6h; AUCins.6-12h, AUCins.6h-infinite, Tmax; Pharmacodynamic parameters (PD): AUCTIG0-4, AUCTIG0-6h; AUCTIG6-T, duration of action; TTIGmax. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). 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. | — |
Countries
Brazil
Contacts
Public ContactSérgio Vêncio
Instituto de Ciências Farmacêuticas de Estudos e Pesquisas Ltda.
Outcome results
None listed