CTRI Number	CTRI/2012/09/003033 [Registered on: 28/09/2012] Trial Registered Retrospectively
Last Modified On:	28/09/2012
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study Modification(s)	Drug Biological
Study Design	Randomized, Parallel Group, Active Controlled Trial
Public Title of Study Modification(s)	12 week comparative study on new a insulin spray versus regular insulin in type II diabetes patients.
Scientific Title of Study Modification(s)	A 12 Week Open Label, Parallel Group, Comparative, Multicentric Phase III Study to Assess Efficacy and Safety of Metered Dose Buccal Insulin Spray versus Rapid Insulin s.c. on subjects with type II Diabetes who are inadequately controlled i.e. HbA1C 6.5 to 8.5 while on Oral Anti- Diabetic Agents
Secondary IDs if Any Modification(s)	Secondary ID  Registry  E11-IN.MDBS-OR-09/02; VERSION FINAL  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name    Address    Phone     Fax     Email
Details Contact Person Scientific Query Modification(s)	Name  Dr K Chandrasekaran  Address  SHREYA LIFE SCIENCES PVT LTD SHREYA HOUSE 301 A Periera Hill Road Andheri East Mumbai MAHARASHTRA 400099 India  Phone  02266938222   Fax  02266939222   Email  kcs@shreya.co.in
Details Contact Person Public Query Modification(s)	Name  Dr KChandrasekaran  Address  SHREYA LIFE SCIENCES PVT LTD SHREYA HOUSE 301A Periera Hill Road Andheri East Mumbai MAHARASHTRA 400099 India  Phone  02266938222   Fax  02266939222   Email  kcs@shreya.co.in
Source of Monetary or Material Support Modification(s)	Shreya Life Sciences Pvt. Ltd., SHREYA HOUSE, 301/A Periera Hill Road, Andheri East, Mumbai 400099, India
Primary Sponsor Modification(s)	Name  Shreya Life Sciences Pvt Ltd  Address  SHREYA HOUSE 301/A Periera Hill Road, Andheri East, Mumbai 400099, India  Type of Sponsor  Pharmaceutical industry-Indian
Details of Secondary Sponsor Modification(s)	Name  Address  Generex Biotechnology Corp  202-33, Harbour Square Toronto, ON Canada M5J 2G2.
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 7   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Paramesh Shamanna  Bangalore Clinisearch, Bangalore  143 Kullappa Layout560084 Bangalore   08025450070 08025430512 d_paramesh@hotmail.com  Dr Siddharth Shah  Bhatia Hospital Mumbai  Tardeo Road 400007 Mumbai   02266660000 02266660566 info@bhatiahospital.co.in  Dr Sunil Gupta  Diabetes Care n Research Centre Nagpur   42 Lendra Park Ramdaspeth 440010 Nagpur   07122428111 mail@drcindia.com  Dr Sujit Chandratreya  Endocare Clinic  Mohiniraj Gangapur Road 422013 Nashik   02532317466 02532317466 sujitchandratreya@yahoo.com  Dr R S Hariharan  Hariharan Diabetes and Heart Care Hospitals Pvt ltd  24 and 26 SWATI 29th Street Naganallur 600061 Chennai   04422247720 04422247724 hariharanhospitals@yahoo.in  Dr Subhankar Chowdhury  JIPGMER and SSKM Hospital Kolkatta  HOD ENDOCRINOLOGY Ronald Ross Building Fourth floor 244 AJC Bose Road 700020 Kolkata   03324404260 03322235076 subhankr.chowdhury@gmail.com  Dr L Sreenivasa Murthy  Life Care Clinic and Research Centre  2253 MCN Complex Kodigehalli Main Road Sahakaranagar 560092 Bangalore   08041735500 0802363055 lifecareclinic@rediffmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 7   Name of Committee  Approval Status  Bangalore Central Ethics Committee 1423 Kullappa Layout Kullappa Circle St Thomas Town PO Bangalore 560084 Applicable to Dr Paramesh Shamanna Bangalore  Approved  Bhatia Hospital Medical Research Society Ethics Committee Tardeo Road Mumbai 400007 affiliated to Bhatia Hospital Mumabi and the EC approval applicable to Dr Sidharth shah of Bhatia Hospital  Approved  Ethics Committee of Diabetes Care and Research Centre 42 Lendra park Ramdaspet Nagpur 440010 EC approval applicable to Dr Sunil Gupta Nagpur  Approved  Hariran Diabetes and Hariharan Chennai Hospitals Ethics Committee 24 and 26 Swathi 29th street Nanganallur Chennai 600061 affiliated to Hariharan Diabetes and Heartcare Hospital Ltd EC approval applicable to Dr Hariharan chennai  Approved  Institutional Ethics Committee Institute of Post Graduate Medical Education and Research 244 AJC BOSE road Kokatta affiliated to IPGMEandR Kolkatta applicable to Dr Subhankar Chowdhury Kolkatta  Approved  Life Care Ethics Committee 2253 MCN complex Kodigehalli Main Raod Sahakara Nagar Bangalore affiliated to Lifecare Clinic and Research Centre Bangalore EC approval applicable to Dr S R Sreenivasa Murthy Bangalore  Approved  Veridian Ethics Committe Nashik 5 yogchaitanya Kalpananagar Off College Road Nasik 422005 EC approval applicable to Dr Sujit Chandratreya Nasik  Approved
Regulatory Clearance Status from DCGI Modification(s)	Status  Approved/Obtained
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  Type II diabetes
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  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 this dose will be in terms of Number of sprays per meal and to be given in split puffs before and immediately after each meal. Total Duration of therapy will be 12 weeks  Comparator Agent  Recosulin  Recombinant human rapid insulin for administration by s.c. route. Dose will be fixed based on average fasting glucose level. The dose fixed will be given as s.c. inj 30-45 mts. before each meal. Duration of therapy will be 12 weeks
Inclusion Criteria Modification(s)	Age From  18.00 Year(s) Age To  75.00 Year(s) Gender  Both  Details  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
ExclusionCriteria	Details  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.
Method of Generating Random Sequence Modification(s)	Random Number Table
Method of Concealment Modification(s)	Not Applicable
Blinding/Masking Modification(s)	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  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.  0 6 and 12 weeks
Secondary Outcome Modification(s)	Outcome  TimePoints  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.  reduction in HbA1c level in 12 weeks
Target Sample Size Modification(s)	Total Sample Size="200" Sample Size from India="200"
Phase of Trial Modification(s)	Phase 3
Date of First Enrollment (India) Modification(s)	17/08/2010
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial Modification(s)	Years="2" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	none
Brief Summary Modification(s)	This is a phase III study to assess the efficacy and safety of the use of a novel delivery of insulin system where insulin is delivered in the bucal cavity of type two diabetes who have failed to achieve good control of Blood glucose. The patients who use this buccal delivery of insulin are compared with those who use injectable regular insulin.