Health Condition 1: null- Type II diabetes
Conditions
Interventions
Intervention1: Generex Oral-LynTM/Oral Recosulin: A metered dose buccal insulin spray containing recombinant human rapid insulin.
Based on the average fasting glucose levels, dose will be fixed and th
Sponsors
Shreya Life Sciences Pvt Ltd
Generex Biotechnology Corp
Eligibility
Inclusion criteria
Inclusion criteria: 1 He or she must be between the ages 18 to 75 years 2. Should be having an history of type 2 diabetes with OHA treatment failure indicated by HbA1C of more than 6.5% 3. Current HbA1C level should be between 6.5 to 8.5 4. No clinically significant abnormalities be seen at the time of physical examination including vital signs or ECG etc Have a body mass index 5. BMI less than 28 6. patient must be Willing to follow the American Diabetes Association or the International Diabetes Federation diet guidelines for Type 2 Diabetes Mellitus 7. Must be able to commit to perform self home blood glucose measurement using glucometer and record hypoglycemic and other adverse events 8. Must be Willing to give written informed consent prior to inclusion into the study 9. If the patient is a female of child bearing potential then must be using a reliable form of birth control and be willing to continue as such for the duration of the study
Exclusion criteria
Exclusion criteria: Patient will be excluded from the study if he/she meets any of the following exclusion criteria: ? Have a history or presence of significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease, or conditions known to interfere with the absorption, distribution, metabolism, or excretion of insulin (other than diabetes mellitus); ? Have moderate to severe chronic diseases of the buccal cavity (involving >33% of the buccal cavity and/or deeper tissues of oral cavity), oral lesion(s) and/or active disease involving the oral cavity, including ulcers and/or gingivitis which would prevent proper use of the Generex Oral-LynTM= RapidMist? System; ? Have a history of drug or alcohol dependency or psychological disease; ? Have any clinically significant acute or chronic illness duringth e 4 weeks prior to admission into the study; ? Require regular use of medication (other than insulin for treatment of DM) that interferes with the absorption, action and/or metabolism of insulin or on concomitant medications that alter blood glucose levels (e.g., steroids); ? Participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study; ? Are pregnant or lactating; ? Have a diagnosis of Type-1 Diabetes Mellitus; ? Have a history of frequent episodes of ketoacidosis or hypoglycemia (seizures or coma) within 6 months prior to admission to this study; ? Have elevated liver enzymes (ALT, AST, alkaline phosphatase), as follows: if any two of the liver enzymes is >3 times the upper limit of normal; or, ? Have poor oral hygiene.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in glycemic control from the base-line as reflected by home self-monitored 4 point blood glucose levels measured daily and by home self-monitored 7 point blood glucose levels measured prior to each site visit using glucometer, in each group.Timepoint: 0 6 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in HbA1c levels from baseline at each site visit, in each group. ? Changes in glycemic control in buccal insulin spray group versus rapid insulin s.c. group, as reflected by daily home self-monitored 4 point blood glucose levels and 7 point blood glucose levels using glucometer, prior to each site visit. ? Changes in HbA1c levels in buccal insulin spray group versus rapid insulin s.c. Group.Timepoint: reduction in HbA1c level in 12 weeks | — |
Countries
India
Contacts
Public ContactDr KChandrasekaran
Outcome results
None listed