IRCT138808111414N4
Completed
Phase 1
Efficacy assessment of the Superporous Hydrogel (SPH) polymer-based oral insulin delivery systems on plasma glucose in patients with type 1 diabetes
Endocrinology and Metabolism Research Center0 sites15 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Dibetes mellitus.
- Sponsor
- Endocrinology and Metabolism Research Center
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- Not provided
Outcomes
Primary Outcomes
Not specified
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