A Randomized, Double blind, Placebo controlled, Phase 2 Clinical Study to evaluate the Efficacy and Safety of TLPL/AY/04/2008 as an Add-on therapy with Oral Hypoglycemic agents (OHA) in Type 2 Diabetic Patients.

Patients of Type-2 DM attending outpatient clinic at Noble Hospital will be screened for eligibility criteria. On screening visit, a written informed consent will be obtained from subjects for their participation in the study. Subject’s history will be recorded and his/her physical examinations will be done. Then patient will undergo investigations (viz. CBC, ESR, Hb%, BSL Fasting and PP,Urine Sugar (Fasting & PP) Serum insulin, HbA1C, Liver function tests, Renal function tests, Lipid profile, Urine routine and microscopic examinations, Urine pregnancy test (only if the subject is female of child bearing potential), Stool routine & microscopic examinations, HIV test, X- ray chest (PA View) and ECG). Diary card to record daily symptoms of diabetes will be provided to patients. A wash out period of 7 days will be advised during which patients will have to refrain from anti-diabetic medicines (Herbal /homeopathic etc) other than OHA prescribed by Investigator. On baseline visit, subject will be recruited in the study if he/she meets all the inclusion criteria. Subjects will then be randomized to one of the two study groups as per the computer generated randomization list. Subjects will undergo general and systemic examinations. At baseline visit and on every follow up visit (except last follow up visit), subjects will be provided with diary card to record daily symptoms of DM. On every follow up visit, filled diary card will be collected and symptoms assessed and graded on clinical symptom scoring scale as given in Appendix-C. At baseline visit and at every follow up visit (except last follow up visit), as per computer generated randomization list, subjects will be provided a HDPE container containing 72 tablets (60 tablets for 15 days + additional 12 tablets for use if the follow up is delayed maximum by three days) of either ?TLPL/AY/04/2008? or matching placebo. Subject will be advised to consume medication in a dose of 2 tablets twice daily orally before meals for next 15 days. Subject will be advised to continue his/her allopathic anti-diabetic medicines (OHAs). Drug compliance will also be assessed by the investigator on every follow up visit. Subjects will be advised to continue the diabetic diet and exercise regimen (which they are already following) during the entire study. Subjects will be called to Noble Hospital for follow up visits on every 15th day upto 90 days after the baseline visit. On every follow up visit, they will undergo general and systemic examinations and assessment of clinical symptoms of type 2 DM will be done. Subject?s blood sugar (fasting & PP) and Urine sugar (Fasting & PP) will be checked on every month. Patient?s global evaluation for overall improvement and Investigator?s global evaluation for overall improvement will be done on completion of the study. Tolerability of the trial drugs will be assessed by the investigator and by the patient at the end of the trial. All the patients will be closely monitored for any Adverse Events starting from baseline visit till the end of the study visit. On final follow up visit (i.e. Day 90) subjects laboratory investigations (viz. CBC, ESR, Hb%, BSL (fasting & PP), Urine Sugar (Fasting & PP), Serum insulin, HbA1C, Liver function tests, Renal function tests, Lipid profile, Urine routine & microscopic, Stool routine & microscopic) will be performed. After completion of 90 days of study treatment, all the subjects will be asked to stop trial medication and take advice of investigator for further treatment.