Type 1 diabetes mellitus
Conditions
Interventions
Phase 1 clinical trial , monocentric, randomized, double blind, 2 treatments crossed-over, 2 periods with 14 (± 7) wash-out days between doses , comparing two recombinant human insulin NPH, NPH human
Biological/vaccine
D06.472.699.587.200.300.200
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 doseaccording to the algorithm described in the protocol;Have positive antiGAD antibody or antiIA2 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: To compare pharmacokinetics (PK) and pharmacodynamics (PD) of two recombinant human insulin NPH: NPH Human Insulin (BIOMM S.A / Bioton) vs Humulin® N (Eli Lilly Brasil Ltda.) in type 1 diabetic patients (T1DM). Primary Parameters: • Pharmacokinetic parameters (PK): AUCins.0-24h e Cins.max. • Pharmacodynamic parameters (PD): AUCTIG0-24h e TIGmax. Secondary parameters: • Pharmacokinetic parameters (PK): T1/2; AUCins.0-t, AUCins.0-12h; AUCins.12-24h, AUCins.0-6h, AUCins.6-12h, AUCins.6-24h, AUC0-_: Tmax; • Pharmacodynamic parameters (PD): AUCTIG0-t, AUCTIG0-12h; AUCTIG12- 24h; AUCTIG6-12h;AUCTIG0-6h, AUCTIG0-4h, AUCTIG6-24h, Tinitial and TTIGmax. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective: To assess local safety and tolerability after dosingunique of two recombinant human insulin NPH: NPH human insulin(BIOMM S.A / Bioton) compared to Humulin® N (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