Dibetes mellitus. insulin-dependent diabetes mellitus
Conditions
Interventions
Intervention 1: Oral insulin- inside polymer capsule-800 U - consumed once. Intervention 2: Placebo-oral capsule with polymer, without insulin - consumed once. Intervention 3: Oral insulin -1600 U out
Treatment - Drugs
Placebo
Oral insulin- inside polymer capsule-800 U - consumed once
Placebo-oral capsule with polymer, without insulin - consumed once
Oral insulin -1600 U outside polymer capsule - consumed once
Oral insulin -800 U - outside polymer capsule - consumed once
Subcutaneous injection of insulin 0.1 unit/kg and is injected once.
Sponsors
Endocrinology and Metabolism Research Center
Eligibility
Sex/Gender
All
Age
17 Years to 45 Years
Inclusion criteria
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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Iran (Islamic Republic of)
Outcome results
None listed