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)(PI)

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.

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, 03, 86,438/- and advancing.
Publications evolved: Trial still ongoing. 1st Publication: Am Heart Jr, 2008, 155, 32e1-e6.

-Prevention and control of Diabetes Mellitus in Rural and Semiurban India Through an
established Network of Hospitals. 2004-2009 (Co-PI). 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. Rs 15,000, 000/-.
Publications evolved: Vide Supra J Assoc Phys Ind.2009, 57,305-309.
Practical Guide to Diabetes Mellitus- 4th Edition (Academa Publishers)

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/-.

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/-.

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/-.

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/-.
Publication: Manuscript on BMD and insulin analogues being worked out.

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 /-.

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)
Study in progress, 120 subjects need to be 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.
A link between lack of energy expenditure through indirect caloriemetry and actiheart has
been established in the low birth weight individuals. Normative values for intra and inter myocellular fat and hepatic fat in Indians has been derived.
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/-.
Publications: More than 10 publications are to be generated through this study from 2009-2011.

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/-.

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/-

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/-.

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 40, 53,378/- and advancing.

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/-.

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/-

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.

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/-.

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/-.

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.

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/-.

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/-.

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. On writing committee for the publication due in 2010.
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: Co-author in the publication being written. Due for 2010.

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]. 2008-2011.
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.
R.C.Min No: 6458. E.C.Min No: IRB-9-16-01-2008, AC.Min.No: 15-J:2-06 .
Grant Amount: Rs 2,000,000/- and advancing.

25. Pfizer Investigator Initiated Research Grant for Immunogenetics of Type 1 Diabetes Mellitus 2008-2009. January-2008. Grant Amount: Rs 400,000/- .

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/-.

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 6,48.000.00/-

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/-

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/-.

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/-.

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

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.

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.

33. Indian Diabetes Educator Project Sponsored by Project-HOPE. A project instituted to
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/-

34. PEARL Study: Postmenopausal Evaluation and Risk-Reduction with Lasofoxifene (PEARL). The protocol requires recruitment of 7500 postmenopausal women with osteoporosis with 33 countries participating around the globe.

35. Protocol H4Z-MC-GJAD titled: “Effects of Arzoxifene on Vertebral Fracture Incidence and on Invasive Breast Cancer Incidence in Postmenopausal Women with Osteoporosis or with Low Bone Density” – A double-blind, randomized, placebo-controlled, Phase 3 study to determine the efficacy of Arzoxifene 20 mg/day to reduce the incidence of vertebral fractures and invasive breast cancer incidence in postmenopausal women with osteoporosis or with low bone density without Osteoporosis.

36. Protocol MK-0822 - Phase III trial on safety and efficacy of Odanacatib in Osteoporosis – by Clinigene 2009.