A study to assess the effect of oral insulin on safety, tolerability, effect of oral insulin on the blood sugar level and effect of oral insulin on the body in typeI Diabetes mellitus patients.
- Conditions
- Health Condition 1: null- Type 1 Diabetes Mellitus
- Registration Number
- CTRI/2009/091/001008
- Lead Sponsor
- Biocon Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
1.Ready for written informed consent.
2.Patients of either gender between 18 to 45 years inclusive.
3.Established diagnosis of TIDM.
4.Body mass Index of 18.5-29.9kg/m2 inclusive.
5.Stable weight.
6.Glycosylated Haemoglobin (HbAIC) 8.0%at screening.
7.On stable insulin or an insulin analogue regimen for atleast 3 months.
•History of hypersensitivity to active or inactive ingredients of the drug
•Significant history of atopy or allergic drug reactions.
•Abnormal lab parameters â?? urine, ECG, hepatic and renal function
•History of drug or alcohol dependence or abuse within 6 months prior to screening.
•Insulin resistance
•Patients on glucocorticoids, other blood-glucose lowering drugs
•Uncontrolled hypertension and hyperlipidemia
•Evidence of severe secondary complications of diabetes
•History of hypoglycemia or hypoglycemia unawareness
•Any hospitalization or emergency room visit due to poor diabetes control within 6 months prior to screening.
•Diseases like coronary artery disease, history of stroke, hematological disorders, planned surgery
•Pregnancy, lactation, or planned pregnancy
•The patient has received another investigational drug
•Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC ratio from 0-130 min for PK and PD with Lispro for different dosesTimepoint: 0-130 min
- Secondary Outcome Measures
Name Time Method Other PK primary and secondary parameters, PD and PK ratio of AUC at different other time intervals till 250 min <br/ ><br>Safety and tolerability <br/ ><br>Timepoint: 0-70min, o-190 min and 0-250 min