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  S. Poongothai  
   
 

Academic Qualification:    

 

Degree

Year

B.Sc (Nutrition & Dietetics)

1986

M.Sc (Psychology)

2002

PDCR (Professional Diploma in Clinical Research)

2005

Ph.D

2010

   
 

RELEVANT TRAINING:

 

Underwent Introductory Course In Epidemiology – January-1999.

Jan-1999

Completed Course In Case Control Study Designs and Clinical Trials at CMC Vellore

Nov 1998

Underwent GCP training in the year 1998,2000 and 2001

1998,2000&
2001,200

Nominated as a Monitor for a Multinational study in the year 2004

2004

 

Underwent course in Regulatory Affairs

2008

Participated in the workshop on Introduction  to Evidence-Informed Healthcare

March-2009

   
 

CAREER REVIEW

 

Designation

Department

Year
Dietitian cum Patient Educator

M.V. Diabetes Specialities Centre Pvt. Ltd

May 1992 to 1994

Research Officer

Dr. Mohan’s Diabetes Specialties centre Pvt. Ltd

May1994 to 1998
Chief Research Officer

Madras Diabetes Research Foundation

May 1998  to May 2008

Head-Clinical Trials Operations

Madras Diabetes Research Foundation

June 2008 till date
   
 

Completed Trials (n= 78)

 
  1. Normopan –SF - Natural Remedies
  2. Diabecon - Himalayan Pharmeuctical
  3. Gemfibrozil - Parke Davis
  4. Creon - Solvay Pharmaceuticals
  5. Glucobay - Bayer
  6. Reclide - Dr.Reddy’s
  7. Glyboral - USV
  8. Rosiglitazone - (Dr.Reddy's)
  9. Repaglinide – Novo Nordisk
  10. Combination Therapy with Human Insulin and Sulphonylureas In Indian
  11. NIDDM Patients - Novo Nordisk
  12. Rosiglitazone - Torrent
  13. NN2344 – 1185 – Phase II Trial - Novo Nordisk
  14. Cardace - Hoechst
  15. Novomix (GCP) – Novo Nordisk
  16. DCBT - Dalmia  Centre for Biotechnology
  17. Cogent DB - Cybele Herbal Laboratories
  18. Novolet - Novo Nordisk
  19. Sit-100 - Lilly
  20. Hyponidd - Charrak Pharma
  21. Doxasozin - Hoechst Pharma
  22. Diamicron MR - Serdia Pharma
  23. F3Z - IN-IONL - Lilly
  24. Human Insulin Zinc Suspension (Lente) - Wochardt
  25. GOURDIN - Pfizer
  26. NN622-1343 - Novo Nordisk
  27. ASDIAB - Novo Nordisk
  28. CL3-21403-010-IND - Serdia Pharma
  29. BI/PM/001/IND - Biocon
  30. Oral Insulin - Hemisphere
  31. BI/NPH/001/IND - Biocon
  32. BI/REG/001/IND - Biocon
  33. Clinical Evaluation of the Efficacy and Safety of Atorvastatin+
    • Fenofibrate - Cipla
  34. NMITLI-DM-FN-01 - SPAARC
  35. F3Z-IOOI-IOL - Lilly
  36. LY333531Treatment for Symptomatic Peripheral Neuropathy In Patients with Diabetes Lilly
  37. Nerve Conduction - Lilly
  38. Pegvisomant - Pfizer
  39. LAF 237 - Novartis
  40. LAF 237(Extension Study) - Novartis
  41. CLAF 237A239 & CLAF237A2329E1 - Novartis
  42. INSULIN GLARGINE(rDNA origin) - Wochardt
  43. DREAM - Aventis & Mcmaster
  44. EPI-DREAM - Aventis & Mcmaster
  45. EXENATIDE - Lilly
  46. MK-0431 -Merck
  47. FAITH  - USV
  48. ROSUVASTATIN  - Investigator driven study
  49. LY333531 - Lilly
  50. SYR-322-SULF-007 - Takeda
  51. SYR-322-MET-008 - Takeda
  52. SYR-322-TZD-009 - Takeda
  53. SYR-322-PLC-010 - Takeda
  54. SYR-322-INS-011 - Takeda
  55. 01-05-TL-322OPI-001 - Takeda
  56. 01-06-TL-322OPI-002 - Takeda
  57. DIATHEA
  58. ADVANCE - Serdia & George Insittute
  59. VILDAGLIPTIN MONOTHERAPY - Novartis
  60. Control on Pre-Clinical Artherosclerotic Markers in Type II Diabetes - Johnson & Johnson
  61. NN 1998 – 1682 - Novo Nordisk
  62. H7U-MC-IDAW - Lilly
  63. H7U-MC-IDAV(a) - LIlly
  64. AGI-1067(ANDES) - AtheroGenics
  65. VIAJECT-06 J Biodel
  66. DREAM-ON - Aventis & Mcmaster
  67. EPI-DREAM ON - Aventis & Mcmaster
  68. ACTIV X 0104-003
  69. POLYCAP - CADILA, St.John’s and McMaster
  70. F3Z-MC-IOOY - Lilly
  71. F3Z-MC-IOPE - Lilly
  72. NMITLI-DM-FN-02 - SPAARC
  73. ICON-39 - BMS
  74. NN2211-1572 - Novo Nordisk
  75. NNC 0113-0217 - Novo Nordisk
  76. BMS- 477118 - BMS
  77. CLF2301210601 - Fournier     
  Fifteen Ongoing Projects:
 
  1. ORIGIN
  2.  Receptor Blockers Protocol B7A-MC-MBDL-Reduction in the Occurrence Of      Center Threatening Diabetic Macular Edema.
  3. A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of SYR 110322(SYR-322) in Subjects with Type 2 Diabetes
  4. A randomized study to Evaluate the role of Spirolactone and Amiloride in the        prevention of Rosiglitazone induced fluid retention in Type 2 Diabetes
  5. An Open-Label,Multi-Center Follow-on Study Examining the Long-Term Safety, and Efficacy of Insulin VIAject Group Study Comparing the Efficacy and Safety of   Insulin  VIAjectä in Subjects with Type 1 Diabetes mellitus
  6. ALTITUDE – A randomized, double-blind, placebo-controlled, parallel group study to determine whether, in patients with type 2 diabetes at high risk for cardiovascular and renal events, Aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality Alone
  7. A Randomized, Double-blind, Active-Controlled, Parallel Group Efficacy and Safety Study of BI 1356 (5.0 mg, administered Orally Once Daily)Compared to Glimperide (1 to 4 mg Once Daily)over Two Years in Type 2 Diabetic Patients  With Insufficient  Glycaemic Control Despite Metformin Therapy
  8.  A randomized,double-blind,placebo-controlled, 2 arm parallel-group,multicenter 24-week study followed by an extension assessing the efficacy and safety of AVE0010 on top of a sulfonylurea in patients with type 2 diabetes not adequately controlled with sulfonylurea
  9. A multi-center,randomized,double-blind study to evaluate the efficacy and long-term safety of Vildagliptin modified release(MR)as monotherapy in patients with type 2 diabetes (CLAF 237B2201)
  10. A Multicenter randomized double blind study to evaluate the efficacy & long term safety of vildagliptin modified release (MR) add-on therapy to metformin in patients with type 2 diabetes  (CLAF 237B2224)
  11. A Multicenter, Randomized, Double-Blind ,Placebo Control Study of IN-105 tablets [oral insulin]in patients with Type 2 Diabetes Melitus who have inadequate  Glycemic Control on Optimal doses of Extended Release Metformin Tablets
  12. Heart Outcomes Prevention Evaluation (HOPE)-313.
  13. A randomized,double-blind,placebo-controlled, 2 arm parallel-group,multicenter 24-week study followed by an extension assessing the efficacy and safety of AVE0010 on top of a sulfonylurea in patients with type 2 diabetes not adequately controlled with basal Insulin

Ongoing Sub studies

  1. GRACE
  2. BMD
  3. DSS

Study Related Training and Conferences

  1. Participated In the 16th International Diabetes Federation Conference Held at Helsinki, Finland & Presented a Poster
  2. Participated In the 7th Novo Nordisk Update and Received an award for the Best Poster Presentation
    February- ‘99
  3. Participated In the 1st International Symposium on Clinical Trials – Sydney September1999.
  4. Underwent GCP Training – 1998 And 2000
  5. Participated In the Clinical Trial held By Pharmacia and Upjohn In July 1999.
  6. Participated In the Conference of Indian Association of Biomedical Scientists In April’2001 and Presented a Poster.
  7. Underwent Advanced GCP Training – Singapore- October ‘2001
  8. Participated In the Investigator’s Meeting for the Advance trial held in Delhi, 2001
  9. Participated in the Investigator’s Meeting for the GOURDIN Trial held in Mumbai, January 2002
  10. Participated in the Investigator’s Meeting for the NMITLI Project held in Mumbai, April2002
  11. Participated in the Investigator’s Meeting for the ADVANCE Study held in New Delhi, June 2002
  12. Participated in South East Asian Meeting on ADVANCE held in Kuala Lumpur, July2002
  13. Participated in NMITLI project Update held in Chennai, August 2002
  14. Participated in the Investigator’s Meeting for the Study DREAM held in Quebec, Canada, August 2002
  15. Participated in the ADA-Post Graduate course in Diabetology, Chennai, September 2002
  16. Participated in the Investigator’s Meeting for the Study DREAM held in Bangalore in December 2002 and delivered a talk on Recruitment strategies in Clinical trials
  17. Participated in the MDRF-UAB National Seminar on Diabetes and Cardiovascular Epidemiology held in March-2003.
  18. Participated in the NN622-1343 Closing Meeting held at Thailand in March 2003
  19. Participated in the 18th International Diabetes Federation held at Paris, 2003
  20. Completed online course on the Collaborative IRB Training Imitative (CITI),18.06.2003
  21. Underwent “UAB Vocabulary of Clinical Research” September 15th to 26th, 2003 at Alabama, USA   “Clinical Research Training for studies of CVD in India”.
  22. International Clinical, operational and Health Services Research Training Award” at University Of Alabama, Birmingham. USA September 1- October 10,2003.
  23. Participated in 1st CDC short course on Diabetes at Atlanta, USA 2003
  24. Participated in the DREAM Investigators’ meeting held at Chennai, January 12,2004.
  25. Participated in the ORIGIN Indian Investigators’ meeting held at Chennai, January 13,2004.
  26. Participated in the Steering Committee meeting for the NMITLI project held at Mumbai, April 6, 2004 and also appointed as a Monitor for the same
  27. Participated and presented data for the ongoing study DM-FN-01 at the NMILTI Project meeting held at Mumbai, October 1st, 2004
  28. Monitor the Site –NIMS for the ongoing study ”NMITLI” at Hyderabad, Nov’2004
  29. Participated in the closure meeting for the prospective study ASDIAB (Asian young Diabetics) held at Singapore, Dec’ 2004
  30. Participated in the Start-up Meeting-B7A-MC-MBDL held at Vienna, Austria  January 2005
  31. Participated in the MDRF-UAB National Seminar on Diabetes and Cardiovascular Epidemiology held in March 2005.
  32. Monitor the site –NIMS for the ongoing study” NMITLI” at Hyderabad, Oct’ 2005
  33. Participated in the Investigator’s meeting held at Barcelona, Spain February 2006
  34. Participated in the MDRF-UAB National Seminar on Diabetes and Cardiovascular Epidemiology held at Dr.Mohan’s Diabetes Specialities –March 9th to 12th, 2006
  35. Participated in the Investigator’s Meeting held at Chennai for the studies-IDAW & IDAV– 29th and 30th July, 2006
  36. Participated in the MDRF-ADA Post Graduate course in Diabetology, Chennai, October 2006
  37. Participated in the ADVANCE regional meeting held at Melbourne, November 2006
  38. Participated in the Investigator’s Meeting held at Chennai for the studies-IOOY & IOPE –17th and 18th Aug, 2007
  39. Participated in the PRECONFERENCE MEETING ON REGULATORY AFFAIRS held on 13th January ,2008  at Mumbai
  40. Participated in the NN2211-1572 Liraglutide Result Lead II meeting held at Singapore on January 2008
  41. Participated in the Investigator’s meeting conducted by Indigene on 16th December,  2008,Chennai
  42. Participated in the Investigator’s meeting conducted by Novartis for the study CLAF 37B2224 at Mumbai-February 2009
  43. Participated in the Investigator’s meeting conducted  for the study TECOS at Goa-May 2009 and delivered a talk on'' Indian Site Experience in Clinical Trial
  44. Participated in the Investigator’s meeting conducted by Novartis for the study CACZ 88512202  at London-May 2009
List of Publications
  1. Poongothai S., Mohan V.  Effect of Normopan SF (Ayurvedic compound) in NIDDM Patients with secondary failure to oral hypoglycaemic drugs. THE ANTISEPTIC. 9:298-299, 1996
  2. Mohan V,  Vijayaprabha R,  Rema M,  Premalatha G,  Poongothai S,  Deepa R, Bhatia E,  Mackay IR,  Zimmet  P. Clinical profile of lean NIDDM in South India. Diabetes Research and Clinical Practice. 38: 101-108, 1998.
  3. Poongothai S, Mohan V. Trial of once daily Gemfibrozil (900 mg) in the treatment of hyperlipidemia in diabetes. The Asian Journal of Diabetology 1: 19-22, 1999.
  4. Mohan V., Poongothai S., Pitchumoni C.S. Oral pancreatic enzyme in the control of diabetes mellitus in tropical calculous pancreatitis. INTERNATIONAL JOURNAL OF PANCREATOLOGY.  24: 19, 1999.
  5. Poongothai S., Rema M., Mohan V. A preliminary report on South Indian diabetic patients from the Asian Young Diabetes Research Study (ASDIAB Study). Novo Nordisk Diabetes Update, Vaz JA, Joshi JK, Moorthy NS (eds), Communication Workshop (P) Ltd., Bangalore, 14 (Abs): 1999.
  6. Mohan V, Poongothai S, Deepa R, Lakshmi Subramanian S, Nalini K, Murali PM. Efficacy of DCBT 2345- An Ayurvedic compound in treatment in Type 2 diabetc patients with secondary failure to Oral drugs – Randomized Double Blind Placebo Control Study. International Journal of Diabetes in Developing Countries.  21: 176-183, 2001.
  7. S. Poongothai, K. Karkuzhali, J. Sharadha, R. Deepa, V. Mohan. Evaluation of safety and efficacy of hyponidd,an ayurvedic compound : A Double Blind, Placebo controlled Study In Type 2 Diabetic Patients With Secondary Failure To Oral Drugs.INT.J.DIAB.DEV.COUNTRIES .22: 19-27,2002.
  8. Mohan V, Poongothai S, Deepa R.  Glipizide improves plasma c-peptide levels over a three-year period after diagnosis of Type 2 diabetes.  International Journal of Diabetes in Developing Countries.  22; 75-80, 2002.
  9. Mohan V, Deepa R, Shefali AK, Poongothai S, Monica M, Karkuzhali K. Evaluation of One Touch Horizon – A highly affordable glucose monitor. Journal of Association of Physicians of India. 52; 779-782, 2004.
  10. Poongothai S, Lavanya S, Deepa R, Mohan V. Randomized trial on the effect of Atorvastatin verses fenofibrate on serum lipid profile among type 2 diabetes subjects-Fenofibrate and atorvastatin in Treating Hyperlipidemia (FAITH) Trial. Diabetic Medicine (in press)
  11. The DREAM Trial Investigators. Rationale design and recruitment characteristics of a large, simple international trial of diabetes prevention: the DREAM Trial. Diabetologia (2004). 47:1519-1527 (Study Co-ordinator)
  12. S. Poongothai. K. karkuzhali, G. Siva Prakash, T. Sangeetha, G.Saravanan, R.Deepa Sharadha Gopalakrishnan,V.Mohan. Effect of Essentiale in Diabetic Subjects with Non-alcoholic fatty liver. International Journal of Diabetes in Developing Countries.  25; 12-19, 2005.
  13. The DREAM Trial Investigators Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose Tolerance or impaired fasting glucose: a randomized controlled trial. (Study Co-ordinator)
  14. The DREAM Trial Investigators. Effect of Ramipril on the Incidence of Diabetes (Study Co-ordinator)
  15. Effects of Ramipril and Rosiglitazone on Cardiovascular and Renal Outcomes in People With Impaired Glucose Tolerance or Impaired Fasting Glucose: Results of the Diabetes REduction Assessment with ramipril and rosiglitazone Medication (DREAM) trial The DREAM Trial Investigators Diabetes Care 2008 31: 1007-1014 (StudyCo-ordinator)
  16. Poongothai.S, Pradeepa.R, Ganesh.A, Mohan.V. Reliability and Validity of a Modified Phq-9 Item Inventory (Phq-12) as a Screening Instrument for Assessing Depression in Asian Indians (Cures - 65). Journal of The Association of Physicians of India. 2009;57:147-52
  17. Effects of a polypill (polycap) on risk factors in middle-aged individuals without cardiovascular disease (tips): a phase ii, double-blind, randomised trial.The Indian Polycap Study (TIPS). Published online March 30, 2009 DOI:10.1016/S0140-6736(09)60611-5 (Study Co-ordinator)
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