Research Projects

  1. Principle investigator in a in transplantation of genetically engineered insulin-producing hepatoma cell lines. Macrocapsulating these cell lines, and transplanting them intraperitoneally into nude rats with streptozotocin induced diabetes mellitus. Analysis of insulin producing cell viability after rat sacrifice and flow cytometric analysis, viability staining, and macroscopic analysis of dissected chambers. (2000) Thomas N
  2. PRIME Study- Pioglitazone in Ramzan in Muslims and it's Effects.- The first Prospective Randomised double-blind multicentric drug trial in Ramzan ever. (PI- sponsored by USAID-Young investigator award- INCLEN, 2003). (PI) [PHASE III]. Study completed and published. Grant amount: Rs 2, 42,000/-. AC.Min.No.: 46-n:6-2003. Publication: Vide Supra- Int J Diab Developing Countries 2006, 26, 39-45. Thomas N
  3. ORIGIN Trial- (Site PI) [PHASE III]. 2004-2011. The leading site in terms of recruitment and retention in Asia and Europe. A Multicentre, international, randomized 2X2, Factorial design study to evaluate the effects of Lantus (Insulin glargine) versus standard care, and of omega-3-fatty acids version placebo, in reducing cardiovascular. R.C. No.: 5401 20-07-2004. IRB. (EC): 5/30/08/03. AC.Min.No.:100-t. Grant amount: Rs 1, 34, 86,438/- and advancing. Publications evolved: Trial still ongoing. 1st Publication: Am Heart Jr, 2008, 155, 32e1-e6. Thomas N
  4. WDF (World Diabetes Foundation Grant) Prevention and control of Diabetes Mellitus in Rural and Semiurban India Through an established Network of Hospitals. 2004-2009 (Co-PI), along with Prof Abraham Joseph, Dr Vijay Aruldas and Dr Mannam Ebenezer A unique project, the first large scale national rural diabetes education project in India. One hundred hospitals have been covered and a structured course, follow up strategy and book have developed. 700 diabetes nurse educators have been trained, 300 doctors, 80 foot care technicians and 20 cobblers from across the country. 24 course sessions (10 days) have been conducted of for doctors and 21 course sessions for educators (13 days). 25 hospitals have been visited and evaluated in detail. AC.Min.No.60-r: 7-04. Grant Amount :Rs 15,000, 000/-. Publications evolved: Vide Supra J Assoc Phys Ind.2009, 57,305-309. Practical Guide to Diabetes Mellitus- 5th Edition (Academa Publishers) Thomas N
  5. Detemir Trial- Multinational Trial: 2004-2006 (Site PI) [PHASE III]. Study completed. Insulin Detemir in Type 1 subjects with diabetes. R.C. No. : 5349; Grant Amount: 6,81,890/-. Thomas N
  6. GRACE Study- Multinational Trial: 2003-2008. Site PI). [PHASE III]. Glucose Reduction and Atherosclerosis Continuing Evaluation. R.C. No.: 5401. Grant Amount: Rs 1,100,000/-. Thomas N
  7. GOLD Study- (Site PI) [PHASE II]. Study completed. The joint leading site in terms of recruitment in India and the world. A double-blind, proof of concept trial of the use of Pegvisomant to reduce urinary albumin excretion in Type 1 and 2 diabetic patients treated with Angiotensin Convertase Inhibitors I Angiotensin Receptor blockers, with persistent albuminuria. R.C. No: 5553, Ac.Min.No.22-S: 3-05. Grant Amount: Rs 8, 98,000/-. Thomas N
  8. Bone Densitometry in patients with insulin analogues- a prospective study. (International Co-Author and Co-PI). Papaioannou A, Thomas N, Kanakamani. A Multinational trial jointly conducted by McMaster University, Hamilton and Christian Medical College, Vellore. 2005-2007. Study of fracture and Bone mineral density in ORIGIN trial participants (Origin Osteoporosis Sub-study). R.C.Min. No.: 5595. Grant Amount: Rs1,89,000/-. Thomas N
  9. Inhaled Insulin study in patients with obstructive lung disease. Multinational trial. 2005-2007. (Site PI) [PHASE III]. The leading site in terms of recruitment in India. Study completed. H7U-MC-IDAS, A Pivotal Open-Label, Parallel Study to Evaluate the Safety and Efficacy of Human Insulin Inhalation Powder (HIIP) Compared To Injectable Insulin Inhalation Powder (HIIP) Compared to Injectable Insulin in Patients with Diabetes and COPD or Asthma. R.C.Min.No.: 5656. E.C.Min.No.: IRB (EC). AC.Min.No.117-a:12-05. Grant Amount: Rs 1,915,000 /-. Thomas N
  10. Copenhagen-Vellore University Collaboration on: Low Birth Weight and the risk of glycaemic disorders as assessed by glucose-insulin clamp studies, indirect calorimetry and Hydrogen Nuclear magnetic spectroscopy and the impact of an intensive 6 week phase of exercise. 2006-2011. (PI) 120 subjects have been recruited. The study involves intensive collaboration between the Copenhagen University where several personal from the department of endocrinology have been trained in Denmark for technical purposes including metabolic nurses, radiation physicists and endocrinologists. The department of endocrinology has linked up with community health, biochemistry, and radiodiagnosis to enable this project. The department of endocrinology has become the first in the country to perform hyperinsulinemic euglycaemic clamp studies on a regular basis. Data has evolved to form a basis for insulin sensitivity in young Indian males. R.C. Min.No.: 5879, AC.Min.No. 50-y: 6-06 and AC.Min.No. 2-k: 1-09. Grant Amount: Rs1, 20, 00,000/-. Thomas N
  11. Oral Insulin Study. Multinational trial 2006-2007. (Site PI) [PHASEII]. 2006-2007. Study completed. Ac.Min.No.21-b:3-06. Grant Amount: Rs 1,200,000/-. Thomas N
  12. STEPS Study: Saxagliptin Study Multinational trial 2006-2009(Site PI) [PHASE III]. A multicenter, randomized, double-blind, placebo combination, phase 3 trial to evaluate the efficacy and safety of Saxagliptin in combination with Thiazolidinedione therapy in subjects with type 2 diabetes who have inadequate glycaemic control on Thiazolidinedione therapy alone. R.C. No. 6023 AC. Min. No.: 39-u: 5-06. Grant Amount: Rs 21,78,490/- Thomas N
  13. ACCORD Study. Avosentan Study (Endothelin Antagonist) (Site PI) [PHASE III]. 2006-2007. (Study Terminated internationally). A randomized, double blind, placebo controlled parallel group study to assess the effect of the endothelin receptor antagonist avosentan on time to doubling of serum creatinine, end stage renal disease or death in patients with type 2 diabetes mellitus and diabetic nephropathy. R.C.Min.:5858. Grant Amount: 78,527/-. Thomas N
  14. PPD Study on DPPV-4 antagonists in patients on Oral Hypoglycaemic agents. (Site PI) [PHASE III]. 2006-2011. Protocol No. SYR-322-OLE-12 titled a Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of SYR110322 (SYR-322) in Subjects with Type 2 Diabetes. R.C. Min. No.: 5890. E.C.Min.No.: IRB (EC) 28.04.2006. AC.Min.No. 67-k: 8 -06. Grant Amount: Rs 60, 53,378/- and advancing. Thomas N
  15. IINHALE: AeRx: Inhaled Insulin Study in patients with Type 2 Diabetes Mellitus. (Site PI) [PHASE III]. 2006-2007. The leading site for recruitment in India. Trial ID NN1998-1682. Inhaled pre-prandial human insulin with the AeRx iDMS plus Glimeperide versus rosiglitazone plus Glimeperide in type 2 diabetes: a 26-week, open- Label multicentre, randomized, parallel trial to investigate efficacy and safety. R.C. No. 6020. AC.Min.No: 93-i: 10-06. Grant amount: 8, 60,400/- Thomas N
  16. Metabolex: Meglitisen as an add on therapy for patients with Type 2 diabetes Mellitus. (Site PI) [PHASE II/III]. 2006-2008. A phase 2/3, randomized, double blind, placebo and active comparator controlled, parallel group, multicenter study to determine the safety and efficacy of Metaglidasen (MBX 102) in the treatment of type 2 diabetes in patients sub optimally controlled on Insulin R.C. No: 6022. AC.Min.No. 113-j: 12 – 06. Grant Amount: Rs 16, 39,130/- Thomas N
  17. Prospective Study in the Usage of Metformin versus Glibenclemide in Patients with gestational diabetes mellitus.2007-2010. Self designed and funded by research corpus in collaboration with Obstetrics and gynaecology at CMC, Vellore. Thomas N
  18. Reboxetine in the therapy of peripheral neuropathy in subjects with diabetes. (Site PI) [PHASE III]. 2006-2010. The leading site for recruitment in the world. Study terminated due to and increased prevalence of arrhythmias. Protocol A6061031. A phase 2B long-term, randomized, open label safety and tolerability trial comparing (S-S) Reboxetine (PNU-165442G) with routine care in patients with chronic painful diabetic peripheral neuropathy (DPN). R.C. No.: 6021,IRB(EC)23/09/2006, AC.Min.No.: 13-g:2-07. Grant Amount: Rs 13,56,906/-. Thomas N
  19. IDAZ study for inhaled insulin in Type 2 diabetes with normal pulmonary function. (Site PI) 2007-2009. The leading site for recruitment in the India. A phase 3, open label, crossover study to evaluate the efficacy and safety of Human Insulin Inhalation Powder (HIPP) compared with once daily Insulin Glargine in Insulin naïve patients with type 2 diabetes mellitus on oral agents: Protocol H7U-MC-IDAZ. R.C. No: 6120 E.C. Min.No. IRB (EC) 26.01.2007; AC.Min.No.29-h: 3-06. Grant Amount: Rs 1,300,000/-. Thomas N
  20. Polypill study (Site PI and Steering Committee member) 2007-2008. In conjunction with McMaster University. Study Complete. Published in Lancet, 2009. Nihal Thomas was part of the steering committee and writing committee.A randomized double-blinded controlled trial of the efficacy and safety of POLYCAP versus its components in subjects with at least one additional cardio-vascular risk factor R.C. No. 6019 AC.Min.No.: 29-g: 3-07. Grant Amount: Rs 2,00,000/-. Publication: Vide supra in publication section- Was principle last author in the article; Published in: Lancet 2009. 373(9672):1341-51. This is a landmark publication which has been widely cited and is likely to make a major impact on the management of the metabolic syndrome and diabetes on an international basis. Thomas N
  21. Novartis study on DPPV-4 inhibitor in addition to metformin. 2007-2009. (Site PI) Study complete. A multicenter, double-blind, randomized, active controlled study to compare the effect of 52 weeks treatment with LAF237 50 mg bid to Gliciazide up to 320 mg daily as Add-on therapy in patients with type 2 diabetes inadequately controlled with Metformin monotherapy. R.C.Min.No.: 6152. IRB (EC) - 11.03.07. AC.Min. No.: 38-u: 4-07; Grant Amount: Rs 10, 27,855/-. Thomas N
  22. Wyeth Study on DPPV-4 inhibitor in addition to sulphonylureas or metformin. 2007-2008. (Site PI). Study terminated following inadequate hypoglycaemic impact to comparator arm. Protocol 3180A1-200-WW. A 24-week randomized, double-blind, placebo-controlled, multicenter study of the safety and efficacy of PPM-204 in subjects with type 2 diabetes R.C. No. 6151 AC.Min.No.: 38 T – 4 / 07. Grant Amount: Rs 32,76,660/-. Thomas N
  23. Soluble Insulin Basal Analogue in the management of Type 2 diabetes three types of doses versus glargine. [PHASE II]. 2008-2009. Study Completed. Largest recruiter in the world. A 16 week randomized, open labelled, four armed, treat to target, parallel-group trial, comparing SIBA-D once daily, SIBA-E once daily, SIBA-D Monday, Wednesday and Friday, and Insulin glargine once daily, all in combination with metformin in subjects with type 2 Diabetes failing on OAD treatment. AC. Min. No.: 6424 EC. Min. No.IRB (EC) A2 – 27.2.08, AC. Min. No.: 1-Q: 01-08. Grant Amount: Rs 32, 55, 926/-. Publication: . Insulin Degludec, a new ultra-long-acting basal insulin, used once daily or three-times weekly or once-daily insulin glargine in type 2 diabetes: a 16-week, randomised, open-label, parallel-group trial. Lancet 2011, 377:924-31 PMID: 21396703; landmark publication of a potential molecule. Thomas N
  24. ALITITUDE study. Study of Aliskiren in patient with Diabetes and proteinuria or macrovascular disease and it’s impact on cardiovascular and all-cause mortality. [PHASE III]. 2008-2013. 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 cardio and renal morbidity and mortality. R.C.Min No: 6458. E.C.Min No: IRB-9-16-01-2008, AC.Min.No: 15-J:2-06 .Grant Amount: Rs 6,000,000/- and advancing. Thomas N
  25. Pfizer Investigator Initiated Research Grant for Immunogenetics of Type 1 Diabetes Mellitus 2008-2009. January-2008. Grant Amount: Rs 400,000/- . Thomas N
  26. A Poverty Alleviation and Diabetes Prevention and Management Programme, Gadag, North Karnataka. 2008-2009. Funded by the Global Micro-clinic Group. with additional support staff and site resources. AC. Min. No.:36-d: 5-08. Grant Amount: Rs 800,000/-. Thomas N
  27. HOPE-3 Study. In collaboration with McMaster university and St John’s Unit of Clinical Trials. 2008-2013. (Phase III). A large simple multi centre, international randomized placebo-controlled trial, utilizing a 2X2 factorial design and evaluating cholesterol modification with Rosuvastatin vs. placebo, blood pressure lowering with candesartan/HCT vs. placebo on major vascular events. R.C.Min.No.: 6569.IRB Min. No.: 15-11-06-08. AC.Min.No. 87-D: 10-08. Grant Amount: Rs 19,000,000/- Thomas N
  28. Dapagliflozin in the control of type 2 diabetes- a Renal Sodium Glucose Transport Inhibitor. 2009-2010. (Phase III). A Multicenter, randomized, double-blind, placebo-controlled, parallel group, phase 3 trial to evaluate the safety and efficacy of Dapagliflozin in combination with thiazolidinedione therapy in subjects with type 2 diabetes who had inadequate glycemic control on thiazolidinedione therapy alone. R.C. Min.No. 6665. IRB. Min.No. -1-22-10-2008, AC.Min.No. 16-F: 02-09; Grant Amount: Rs 11, 42,460/- . Thomas N
  29. Metabolex in the control of type 2 diabetes mellitus- a Phase 3 study in comparison with Pioglitazone. 2009-2010. (Phase III). A Phase 2 Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate The Safety and Efficacy of MBX-102/JNJ-39659100 in Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Metformin Monotherapy. IRB Min.No. 6717, AC.Min.No.: 16g:2-09. Grant Amount: Rs 16,00,000/- Thomas N
  30. Saxagliptin in the treatment of subjects with type 2 diabetes on insulin or insulin in combination with metformin. (Phase III). 2009-2011. A Multicentre Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination with Metformin in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination with Metformin. R.C.Min.No.: 6836. Grant Amount: Rs 21, 35,925/-. Thomas N
  31. A Multi-Centre, randomized, Double blind study to evaluate the efficacy and a long term safety of vildagliptin modified release (MR) as add on therapy to metformin in patient with type 2 diabetes. RC.Min.No. 6721, AC.Min.No.43-g:5-09. Grant Amount: Rs 37,79,600/-. Thomas N
  32. Study of prevalence of Diabetes Associated Antibodies and Specific Haplotypes in subjects with Gestational Diabetes in South India. 2007 – 2009. EC.Min.No: IRB (EC) 24.07.2007 dt 10th July 2007. Thomas N
  33. Study of Immunogenetics of Type 1 Diabetes in South India with Karolinska Instiute,Sweden . 2007-2009. EC.Min.No.: IRB(EC)23.07.2007 dt 10th July 2007. Thomas N
  34. Indian Diabetes Educator Project Sponsored by Project-HOPE. A project instituted to train 400 diabetes educators across the country through a 6 month programme with 3 contacts at CMC, Vellore and a distance education programme in between. 2009-2011. Grant Amount: Rs 3,000,000/- Thomas N
  35. A 26 month randomised, controlled, open label, multicentre, multinational, three-arm, treat to target trial comparing efficacy and safety of three different dosing regimens of either Soluble insulin basal Analogue(SIBA) or insulin Glargine with or without combination with OAD treatment, in subjects with type 2 diabetes mellitus. [Trial ID:NN1250-3668]-Phase3a. Grant Amount: 3,000,000/-. Thomas N
  36. Adult Type 1 Diabetes project for patients above the age of 16 years. Supported by the International Diabetes Federation and Diabetes Australia from 2010 to 2017. Grant Amount: US$ 40, 200/- (2,012,000INR). Thomas N
  37. The Impact of Vitamin D replenishment on indices of insulin sensitivity an resistance in subjects with vitamin D deficiency. Thomas N, Kishore P, Hawkins M, Kehlenbrink S, Koppaka S, Morrill M, Sudeep K, Spurgeon R, Siddharth R, Inbanathan M, Christopher S, Fleming J, Arulappan G. Grant Amount: 1,500,000/-. The study utilizes hyperinsulinemic euglycaemic clamp techniques, stable isotopes and is in collaboration with the Albert Einstein University. IRB Min. No.7088 dated 17.02.2010. Thomas N
  38. Safety and Efficacy of HO/03/03 10micg in the treatment of plantar neuropathy diabetic foot ulcers. IRB Min No 7202 dated 21.07.2010 Grant Amount: 18,000,240/- INR. Thomas N
  39. A long term Multicentric International Randomized double blind placebo controlled trial of the Liraglutide Effect and Action in Diabetes: Evaluation of the Cardiovascular Outcome Results. Novo Nordisk. IRB number: 7348, 8th December, 2010 to 2016. Grant Amount: 87,50,000/-. Thomas N
  40. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone. IRB: November 2010. Thomas N
  41. Metabolic Characteristics of Lean Diabetes in Rural and Semi-Urban India". Thomas N, Hawkins M, Kishore P, Kehlenbrink S, Koppaka S, Inbakumari M, Siddarth. In collaboration with Albert Einstein Medical School, Yeshiva University, New York. Grant amount: 3000,000/- INR. IRB Min. No. 7375, dt.27.01.2011. Thomas N
  42. Albert-Einstein New York-Vellore Educational and Charitable grant. For needy diabetes patients and to perpetuate their education and support. Grant amount: 2,000,000/-. AC minute dated: 24th April, 2011. Thomas N
  43. Prevalence of diabetes mellitus, its risk factors and attitude towards diabetic health care in rural population of Arunachal Pradesh, North East India. With Baptist Hospital Tezpur. Grant amount: 4,00,000/-IRB Min. No. 7541. Dated 13.07.2011. Thomas N
  44. The Rishi Valley Vascular Disease Project-- an observational public health project in vascular health in a rural South Indian community living below the poverty line, with long-term follow-up. In Collaboration with Monash University and Rishi Valley Health Centre. Grant Amount: 5,000,000/- IRB Min No. 7539 dated 13.07.2011. Thomas N
  45. D1693C00001: DECLARE Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients with Type 2 Diabetes. IRB Min No. 8643 dated 22.01.2014. Grant Amount: 52,76,700/- Thomas N
  46. PnO Training in India by NIROGI Paadha Programme of Sri Lanka Medical Association Funded by World Diabetes Foundation. Project sponsored by the Sri Lankan Health Ministry and World Diabetes Foundation for training technical staff on diabetes foot care management and education. Grant Amount: Rs.253110/-. AC Min No. 14-f:1/14; dated 23.01.2014. Thomas N
  47. CSOM230G2304: A randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease. IRB Min No. 8644 dated 22.01.2014. Grant Amount: 14,63,000/-. Thomas N
  48. CSOM230B2411.A Phase II trial to assess the efficacy and safety of pasireotide S.C. alone or in combination with cabergoline in patients with Cushing’s disease. IRB Min No: 8905{INTERVEN} dated 23.04.2014.Grant Amount 12,45,600. Thomas N
  49. CLR_10_33.Safety and Efficacy of Exenatide Injection in Subjects with Type 2 Diabetes Mellitus: A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Multicentric, 24 Week Trial. IRB Min No: 8969{INTERVEN} dated 23.07.2014.Grant Amount 1400000/-. Thomas N
  50. CLCI699C2301. A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease. IRB Min No: 9120 { INTERVEN} dated 15.10.2014.Grant Amount Rs.1917700/- Thomas N
  51. CSOM230B2219; A multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult patients with Cushing’s disease or acromegaly. IRB Min No.9228{INTERVEN} dated 17.12.2014.Grant Amount 1160500/- Thomas N
  52. Title of Research Childhood and young adult predictors of myocardial structure and function at age 45 years in the New Delhi and Vellore Birth Cohorts, India. Early predictors of cardiac abnormalities to birth weight and early growth. IRB Min No.9548{OBSERVE} dated 22.07.2015. Grant amount : 22,283,697. Thomas N
  53. BIAsp-4157; A 32-week Randomised, multinational, treat-to-target, open label, parallel group comparison of stepwise insulin intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately controlled on oral anti-diabetic therapy. Role: Co-Investigator. IRB Min No.9546 [INTERVEN] dated 22.07.2015.Grant Amount 1436400/- Thomas N
  54. NN9535-4216. Efficacy and safety of semaglutide versus Dulaglutide as add-on to metformin in subjects with type 2 diabetes.(SUSTAIN 7)- Principal investigator. Grant Amount Rs.2063290/- NN1218-4131:Efficacy and Safety of Faster-acting Insulin Aspart compared to NovoRapid® both in combination with Insulin Degludec in Adults with Type 1 Diabetes: Onset 8.Phase3.Co-investigator.Grant Amount -694710.IRB Min No: 9887 dated 20.Jan.2016.Grant Amount: 2063290/- Thomas N
  55. SOM230B2412 An open label, multi-center pasireotide roll-over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment. Phase 3.Co-investigator.IRB Min. No9950 Dated:17.Feb.2016.Grant Amount -5667200/-. Thomas N
  56. LIVING STUDY: A lifestyle intervention program for the prevention of type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus. Principal Investigator. IRB Min No 10597(INTERVEN) dated 29.03.2017. Grant Amount - 22,13,773.8. Thomas N
  57. AMPLITUDE O: EFC14828.A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk.Phase 3.Co-investigator.IRB Min No 11426 [INTERVEN] dated 25.07.2018.Grant Amount Rs. 8188345.00. Thomas N
  58. SCORED STUDY: EFC14875. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function. Phase 3.Co-investigator.IRB Min No 11259 {INTERVEN} dated 28.03.2018.Grant Amount 17504828.00. Thomas N
  59. SELECT STUDY : EX95364388 : Semaglutide effects on cardiovascular outcomes in people with overweight or obesity Phase 3 Principal Investigator.IRB Min No 11573 (INTERVEN) Dated 31.Oct.2018.Grant Amount 17504828.00. Thomas N
  60. SOUL STUDY: EX9924-4473 : Semaglutide cardiovascular outcomes trial in patients with type 2 diabetes (SOUL).IRB Min No 12298 {INTERVEN} dated 30.10.2019.Grant Amount 9762645. Thomas N
  1. Senior coordinator in Christian Medical College, Vellore under Department of Endocrinology in Pfizer Global Research and Development, Global Phase III Protocol on PEARL (Postmenopausal Evaluation and Risk reduction with Lasofoxifene (Co-PI). From Feb 2003- Jan 2008. Grant Amt Rs.2,00,00,000/- Paul TV
  2. Senior coordinator in Christian Medical College, Vellore under Department of Endocrinology in QUINTILES, Global Phase III Protocol on Generations. (Co-PI) June 2005 – 2009. Grant Amt Rs.1,83,32,261/- Paul TV
  3. Principal Investigator in Christian Medical College, Vellore under the department of Endocrinology in Phase III trial on safety and efficacy of Odanacatib in Osteoporosis. (PI) Jan 2009 – Jun 2015. Grant Amt Rs.1,26,00,000/- Paul TV
  4. Principal Investigator in Christian Medical College, Vellore under the department of Endocrinology in Phase III trial on Efficacy and Safety of AMG 785 Treatment in Postmenopausal Women with Osteoporosis from. From Nov 2012 – Jul 2016. Grant Amt Rs.67,00,000/- Paul TV
  1. Indian Council of Medical Research Grant for the Winter Symposium-2007 in January- 2007 of 100,000/- INR. For Thomas Paul, Nihal Thomas.
  2. CSIR Grant for the Winter Symposium-2007 in January-2007 of 100,000/- INR. For Thomas Paul, Nihal Thomas.
  3. Investigator initiated research Grant for Senthilvasan, Nihal Thomas, CB Sanjeevi in March 2008, for the year 2007, for the Immunogenetics of Type 1 Diabetes. By the Research Society for the Study in Diabetes (RSSDI). 4, 00,000/- INR.
  4. Winter Symposium 2007: Grants Raised: Rs 22, 10,825/-.
  5. Distance education in Diabetes Grant for conducting a 1 year fellowship in diabetes For 100 hundred doctors across India. 2008-2010: 3,000,000/- INR. Publications: Vide Supra- 12 workbook series have been generated. Nihal Thomas.
  6. Comparison of two generic forms of insulin in subjects with Type 1 diabetes. 2009-2010 (Biocon) (Phase III). A randomized active controlled, parallel group, multi-centre, two stage, open label, study comparing safety and immunogenicity of insugen ® R and Insugen ® N with Actrapid ® and Insulatard in patients with type 1 diabetes mellitus. IRB Min.No.: 6835. Grant amount: 15, 30,160/-. Thomas N.
  7. Expression of miR-200 family, miR-205 and cell surface proteins as markers of metastasis in thyroid tumors using real- time PCR and immunohistochemical analysis: With: Pai R, Premkumar AJ, George SM, Hephzibah J, Samuel P, Paul MJ, Rajaratnam S, Thomas N, Oommen R, Shanthly N, Manoj R, Nair A, Seshadri MS. 19,82,379/- INR. (DBT Grant).
  8. Chloroquine in the therapy of diabetes in patients on oral hypoglycaemic agents. IPCA. Grant amount: 1,500,000/-. Thomas N
  9. Isolation of placental perivascular cells (pericytes) and endothelial progenitor cells from Gestational Diabetes to explore early microvascular functional abnormalities. Samuel R, Shrivastava A, Mathew J, Thomas N, Kumar S, Seshadri MS. Applied to DBT, 2012.IRB no: 7896, dated 27th June, 2012.
  10. The study of pregnant women with diabetes and screening for mutations related to common MODY (Maturity Onset Diabetes of the Young) genes and Polymorphisms in TCF7L2. IRB 7894. Dated 27th June, 2012. DBT grant of 70,000,000INR. Thomas N, Rajaratinam S, Paul TV, Chapla A, Jacob M, Mathew J, Jose R, Lionel J, Regi A, Kuruvilla A, Jeyaseelan L..
  11. Targeted Second Generation Resequencing for the Molecular Genetic Diagnosis of Maturity Onset Diabetes of the Young(MODY). IRB: 7774, Dated 22nd February, 2012. Thomas N, Rajaratinam S, Paul TV, Asha HS, Nair VV, Chapla A, Arulappan N, Christina F, Inbakumari M, Pai R, Samuel P. CSIR Grant of 30,000,000 INR.
  12. The manifestations of Wilson’s disease with respect to renal tubular dysfunction, bone health growth and puberty Paul TV, Sajith KG, Asha HS, Thomas N, Eapen CE, Thomas M, Job, V.
  13. Immunological, biological and genetic markers in the reactivation of latent tuberculosis. Arulselvi UI, Balaji V, Michael JS, Thomas N, Danda D.
  14. ALK02-EVO1 A multicenter, randomized, double-blind, double dummy study comparing the efficacy and safety of Evogliptin with Sitagliptin in patients with type 2 diabetes mellitus receiving background therapy with Metformin.Phase 3.Co-Investigator.Grant Amount Rs. 2329900. Thomas N
  15. Drl-Indg02-Lorc/2016. “A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Study To Evaluate The Efficacy And Safety Of Lorcaserin Hydrochloride In The Treatment Of Obesity” Phase 3.Co-Investigator.Grant Amount Rs. 11, 21, 250. Thomas N
  16. GPL/CT/2016/009/III. A 24-week, randomized, double-blind, double-dummy parallel-group, multi-center, active-controlled study to evaluate efficacy and safety of Remogliflozin etabonate in subjects with type-2 diabetes mellitus.RB Min No:10878 (INTERVEN) dated 27.Sep.2017.Grant Amount:3207240/-. Thomas N
  17. TREGO-DM2-03-I-01. An Open Label, Multi-center, Randomized, Parallel Group Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Insulin Tregopil (IN-105) Compared with Insulin Aspart in the Treatment of Patients with Type 2 Diabetes Mellitus on Stable Dose of Metformin and Insulin Glargine.RB Min No:10916 (INTERVEN) dated 27.Oct.2017.Grant Amount: 2124000/- Thomas N
  18. Comprehensive Molecular Studies in Monogenic forms of Diabetes in India”. Thomas N Co-ordinator (Multicentre Study). By the Department of Biotechnology (DBT). The budget approved is: 258.49 lakhs, dated March 27, 2018.Grant No.BT/PR26420/MED/12/774/2017. Thomas N
  19. Principle investigator for National task force project entitled, “Improving the Capacity of Health System and Community for Screening and Management of Some Non-Communicable Diseases among Scheduled Tribes: An Implementation Research in East Khasi Hills District, Meghalaya” Grant No.NTF/NCD/2019/SBHSR/01, Indian Council of Medical Research: Grant Amount:1,00,00,000/-. Thomas N
  1. A Prospective, Comparative, Active Controlled, Randomized, Open label, Multicentre study to compare the Safety and Efficacy of Teriparatide of Enzene Biosciences Ltd. versus Forteo of Eli-Lilly in the Treatment of Postmenopausal Osteoporosis. (PI). From Jul 2018-Jan 2020. Grant Amt.13,00,000/- Dr. Thomas Paul
  2. A Prospective, Active-controlled, Randomized, Double blind, Multicenter Phase III Study to Compare the Safety and Efficacy of Biosimilar Denosumab of Enzene Biosciences Limited versus Innovator Denosumab in the Treatment of Postmenopausal Osteoporosis. (PI) From Jan 2019 – July 2020. Grant Amt.18,00,000/- Dr. Thomas Paul
  1. Copenhagen University Collaboration on: Low Birth Weight and the risk of glycaemic disorders as assessed by glucose-insulin clamp studies, indirect calorimetry and Hydrogen Nuclear magnetic spectroscopy. 2006-2009. (PI)- Dr Nihal Thomas.
  2. Study of Immunogenetic Pattern in Type 1 diabetes in South India - Dr Nihal Thomas , Dr Senthil Vasan.
  3. Bone mineral density and vitamin D status in subjects who are on long term anticonvulsant medication. Thomas V Paul P, TGK.
  4. Bone mineral density and vitamin D status in postmenopausal subjects who are admitted with Hip fracture. Dr Thomas V Paul.
  5. Bone mineral density and vitamin D status in patients infected with HIV infection who were on HAART therapy. Dr M S Sheshadri , Dr Thomas Paul , Asha H S.
  6. study of Immunogenetics of gestational Diabetes and New borns and Offsprings born to Diabetic Mothers - Dr Nihal Thomas , Dr Senthil.Vasan.
  7. Study on Prevelance of Metabolic syndrome in young asian Indian . Dr Nihal Thomas , Dr Senthil Vasan.
  8. Vitamin D Status and Calcium Metabolism in Ambulatory patients on Antiepileptic Drugs. Dr George koshy.
  9. The burden of Osteoporosis in healthy males more than 40 years of age and the Influence of life style factors, Calcium intake and Vitamin D status on Bone Mineral Density from a suburban region in South India. Dr Suresh Prabhu.
  10. Assessing Energy Expenditure in patients with Fibro Calcific Pancreatic Diabetes to help in determining dietary Calorie requirement. Dr Dr Kishore Kumar Behera.
  11. Prevalence of vitamin D deficiency and other risk factors in patients with acute Hip fracture.Dr Sivan Arul Selvan.
  12. Establishing the significance and correlation of Homa, Quicki, Fgir, Matsuda and McAuley's Indices with hyperinsulinemic euglycemic clamp in young South Indian males.Dr Rachaprolu Spurgeon.
  13. Body Composition and Metabolic Abnormalities in HIV infected Men. Dr Asha HS.