Efficacy assessment of the Superporous Hydrogel (SPH) polymer-based oral insulin delivery systems on plasma glucose in patients with type 1 diabetes
Phase 1
- Conditions
- Dibetes mellitus.insulin-dependent diabetes mellitus
- Registration Number
- IRCT138808111414N4
- Lead Sponsor
- Endocrinology and Metabolism Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
inclusion criteria: type1 diabetes, age of 17 - 45 years and the BMI levels =19 and = 27 kg/m2.
Exclusion criteria : any significant GI symptoms, previous hypersensitivity to polymer, clinically diagnosed diabetic gastroparesia, C-peptide> 0.5 ng/dl, forcing patients to use drugs intervention with insulin during study (LHRH agonists, cimetidine, ranitidine, quinolones, estrogen, diuretics, glucocorticoids, ß blockers, somatostatins, pegvisomant, thiazolidinediones and herbal medicines), history of GI bleeding, history of uncontrolled thyroid disease, history of acute febrile illness, history of blood donate in the past 3 months, psychological disease, cardiac disease.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma insulin. Timepoint: At injection visit, 0(immediately before dosing), 5, 15, 30 (immediately before the meal), 60, 90, 120, 180, 240, and 360 min ; and at oral capsule visit, 0 (immediately before dosing), 30, 60, 120, 150, 180 (immediately before the meal), 210, 240, 300, 360 min. Method of measurement: blood sampling with ELISA kits (DiaMetra, Milano, Italy) for insulin.
- Secondary Outcome Measures
Name Time Method Blood suger. Timepoint: At injection visit, 0 (immediately before dosing), 5, 15, 30 (immediately before the meal), 60, 90, 120, 180, 240, and360min; and at oral capsule visit, 0 (immediately before dosing), 30, 60, 120, 150, 180 (immediately before the meal), 210, 240, 300, 360 min. Method of measurement: blood sampling with enzymatic assay (Pars Azmoon, Iran).