:: Affiliated to the Tamilnadu Dr. M.G.R. Medical University, University of Madras
  :: ‘ICMR Advanced Centre for Genomics of Type 2 Diabetes’ :: IDF Centre for Education
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Clinical Trials

 
 

Vision

 
 

1.To provide a world class environment for conducting  state of the art Clinical Research
2. Serve as a national resource centre of international standing in the design, conduction, analysis, Interpretation and dissemination of clinical trials

 
  Mission
 
 

Providing service of world class standard to the study subjects that have agreed to actively participate in facilitating pharmacology based clinical research in diabetes and its complications and to the pharmaceutical companies involved in drug discovery and development in the areas of diabetes and its complications aiding them in various phases of clinical trials to ensure the proper evaluation of new therapies prior to their actual launch into the market. 

 
 

ACTIVITIES OF THE DEPARTMENT

Till date the department has conducted hundred and one national and international trials to its credit. All the 107 trials were ICH-GCP compliant, controlled and essentially double-blinded clinical trials from all the major diabetes-focused pharmaceutical companies across the globe. The department has also been ranked as the Global top recruiter for ten of the 107 trials. A consistently low screen failure rate of < 5% and a high Quality Control (QC) score serve as an indicator of the thorough understanding of the process of clinical research that the department possesses. The low drop-out rate serves both as a measure of the dedication of the workforce in ensuring that any trial undertaken is followed through successfully to its completion and the level to which the clinical trial team takes rapport-building with the study subjects involved in a clinical trial seriously. These factors account for MDRF being preferred as a nodal centre by many pharmaceutical companies involved in drug trials. Audited for about 10 times by the external agency and sponsors to see the compliance with the GCP guidelines and adherence to the study protocol.

 Dr.Poongothai, who is the head of the Clinical trails departments and she has more than twenty years of clinical trials experience and directly supervised a number of international clinical trials in all its clinical phases (II - IV). She is well versed in GCP starting from subject recruitment to SAE reporting. The department has a team of 20 personnel directly connected with Clinical Trials work.

 
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Portfolio of Current Activities of the Department

 
 

Currently the department is involved in 14 global Phase II and III trials.

     FOURTEEN ONGOING PROJECTS:

  • 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
  • Heart Outcomes Prevention Evaluation (HOPE)-3
  • Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in  patients with type 2 Diabetes Mellitus and Inadequate Glycemic Control on Mono- or Dual Combination Oral Anti hyperglycemic Therapy(TECOS)
  • ADVANCE –ON
  • A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ‑28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus (The CANVAS Trial: CANagliflozin CardioVascular Assessment Study)
  • A 2-year, Randomized, Double-blind, Placebo-Controlled, Multi-center, Phase II-III   Evaluate the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate  Diabetic Sensorimotor  Polyneuropathy. Protocol Number AS3201-G000- 291  
  • A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide Administered in Combination With Metformin and Glimepiride Compared With Metformin Plus Glimepiride and Placebo and With Metformin Plus Glimepiride and Pioglitazone in Subjects With Type 2 Diabetes Mellitus
  • A phase III Randomized, double-blind, active-controlled parallel group efficacy and safety study of BI 10773 compared to Glimiperide administered orally during 104 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin treatment
  • A phase III Randomized, double-blind, placebo-controlled, parallel group efficacy and safety study of BI 10773 (10 mg and 25 mg administered once daily)as add on to pre-  existing antidiabetic therapy over 52 weeks  in patients with type 2 diabetes mellitus and 
         renal impairment and insufficient glycaemic control
  • A 26-weeks randomised, parallel two-arm, double-blind, multi-centre, multinational treat-to-target (TTT) trial in subjects with type 2 diabetes inadequately controlled with basal insulin and metformin with or without sulfonylurea (SU or glinides comparing the efficacy and safety of insulin degludec/liraglutide once daily with insulin degludec once daily both added on to metformin.
  • A Multicentre, International, Randomized, Parallel group, Double Blind study to evaluate Cardiovascular safety of Linagliptin versus Glimepiride in patients with type 2 Diabetes Mellitus at high cardiovascular risk.- CAROLINA TRIAL
  • A randomized double-blind placebo-controlled trial for the evaluation of a Polycap, low dose Aspirin and Vitamin D supplementation in primary prevention - The International Polycap Study (TIPS)-3
  • CLAF237A23156: A 5-year study to compare the durability of glycemic control of a combination regimen with vildagliptin & metformin versus standard-of-care monotherapy with metformin, initiated in treatment-naïve patients with type 2 diabetes mellitus
 
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  Portfolio of Past Activities of the Department
 
 

The Clinical trial department completed 107 global Phase II, III and IV trials from the year 1994  till date. Please find the details of the clinical trials.

1. Normapan 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 NIDDM Patients -              Novo Nordisk
11. Rosiglitazone Torrent
12. NN2344 – 1185    Novo Nordisk
13. Cardace      Hoechst
14. Novomix (GCP)   Novo Nordisk
15. DCBT Dalmia  Centre for Biotechnology
16. Cogent DB            Cybele Herbal Laboratories
17. Novolet  Novo Nordisk
18. Sit-100 Lilly
19. Hyponidd Charrak Pharma
20. Doxasozin Hoechst Pharma
21. Diamicron MR Serdia Pharma
22. F3Z - IN-IONL       Lilly
23. Human Insulin Zinc Suspension (Lente) Wochardt
24. GOURDIN Pfizer
25. NN622-1343       Novo Nordisk
26. ASDIAB  Novo Nordisk
27. CL3-21403-010-IND   Serdia Pharma
28. BI/PM/001/IND       Biocon
29. Oral Insulin            Hemisphere
30. POLO   Johnson & Johnson
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. Effect of Essentiale in Diabetic Subjects with Non-alcoholic fatty liver  
37. Efficacy of Atorvastatin +Niacin with Atorvstatin in patients with Dyslipidemia-LUPIN   
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 MBBR Lilly
50. LY333531 MBCW Lilly
51. MBCV Lilly

52.

SYR-322-SULF-007  Takeda
53. SYR-322-MET-008    Takeda
54. SYR-322-TZD-009     Takeda
55. SYR-322-PLC-010      Takeda
56. SYR-322-INS-011 Takeda
57. 01-05-TL-322OPI-001 Takeda
58. 01-06-TL-322OPI-002  Takeda
59. MK 0524 A                   Merck

60.

Survey of Burden of illness (BOI) in Indian patients with Neuropathic Pain-Pfizer  
61. DIATHEA TAFE Stanes
62. ADVANCE Serdia & George Institute
63. VILDAGLIPTIN MONOTHERAPY Novartis
64. Control on Pre-Clinical Artherosclerotic Markers in Type II Diabetes Johnson & Johnson  
65. NN 1998 – 1682  Novo Nordisk
66. H7U-MC-IDAW             Lilly
67. H7U-MC-IDAV(a)  Lilly
68. AGI-1067(ANDES) AtheroGenics
69. VIAJECT-06 J              Biodel
70. DREAM-ON                 Aventis & Mcmaster
71. EPI-DREAM ON           Aventis & Mcmaster
72. ACTIV X 0104-003        Atherogenesis
73. POLYCAP      CADILA, St.John’s and McMaster
74. F3Z-MC-IOOY                Lilly
75. F3Z-MC-IOPE                 Lilly
76. NMITLI-DM-FN-02         SPAARC
77. ICON-39                          BMS
78. NN2211-1572                 Novo Nordisk
79. NNC 0113-0217               Novo Nordisk
80. BMS- 477118                  BMS
81. CLF2301210601 Fournier
82. MBDL  Lilly
83. VIAject   07                      Biodel
84. Rosiglitazone GSK
85. Dutogliptin/PHX1149T    Phoenix
86. CACZ88512207 Novartis
87. NN-1250-3585  Novo Nordisk
88. IN-105                            BIOCON
89. Soluble Insulin                 SIAC
90. CLAF 237B2201              Novartis
91. RO5073031   Roche (the study was terminated )
92. CACZ885I2202 Novartis
93. AVE0010 Sanofi-Aventis (Metformin)
94. Pf-04971729                      Pfizer
95. CLAF 237B2224                Novartis
96. BI 1356.20                          Boehringher
97. AVE0010      Sanofi-Aventis (Basal Insulin)
98. AMR01-01-0016                 Amarin
99. 99. NN1250-3725              Novo Nordisk
100. PolycapTM        Cadila
101. SK-0403-2.01US                KOWA
102. EFC-10781                          Sanofi-Aventis
103. Select Simple                    Johnson & Johnson  
104. SYR-012                            Takeda
105. ORIGIN Sanofi-Aventis & PHRI
106. LC-005                        LG life sciences
107. LC-006                        LG life sciences
 
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  Facilities    
 

Located in a large tertiary care teaching hospital with state-of-art medical and surgical facilities related to diabetes care; what began as a department geared at conducting Phase III clinical trials, has expanded into a Clinical Research Department that is versatile and comprehensive with the capacity to conduct trials in all phases of clinical development of pharmaceutical products. The department interfaces with companies involved in drug discovery and development in the areas of diabetes and its complications aiding them in various phases of clinical trials to ensure the proper evaluation of new therapies prior the actual launch of a drug into the market.  Our research strength has also been growing in new areas such as Combined Pharmacokinetic-dynamic assessment; Insulin Clamp Studies (Normoglycemic and hyperglycemic clamps); Phase I Studies.

AVAILABILITY OF NEW FACILITY
New site for clinical trials started at Tambaram from April 2011.

SOPs introduced
Introduction of 14 SOPs for smooth functioning of the clinical  trials department.

 
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  Research Team  
 

STAFF NAME

DESIGNATION

Dr.S.Poongothai

Sr scientist & Head, Clinical trials

Dr.S.Kasturi

Clinical trial officer & assistant Diabetologist

Ms.Karkuzhali

Senior Research Officer

Mr.Muniyandi

Senior Phlebotomist

Ms.Phebegeniya

Senior study co-ordinator & QA officer

Ms.Sowmya Research Assistant
Mr.Nandakumar

Research Pharmacist

Ms.Sharmila

Research Lab technician

Ms.Gayathri

Research Assistant

Ms.Savitha

Research Assistant

Ms.Devi

Research Pharmacist

Ms.Lakshmi

Data entry operator

Ms.Rajeshwari Research Lab technician
Mr.Senthil Pharmacist & Study Co-ordinator
Mr.Purushothaman Pharmacist & Study Co-ordinator
 
     
 

The Clinical Trial capability of the organization is also supported by a high-powered Institutional Ethics Committee.

 
 

COMPOSITION OF MDRF – INSTITUTIONAL ETHICS COMMITTEE

 
 

STAFF NAME

DESIGNATION

Dr. M. D. Nair

Chairperson

Dr. G. Vijayakumar Vice Chairperson
Dr. M.Balasubramanyam Member Secretary

Dr. R. M. Anjana

Expert Medicine
Dr. I. Ranjit Unnikrishnan Expert Medicine
Dr. Anand Moses Expert Medicine
Dr. Annabelle Rajaseharan Expert Clinical Pharmacology
Dr. M. S. Jawahar

Expert Medicine

Dr. R. Ramakrishnan

Expert Epidemiology & Statistician

Dr. T. Rajkumar

Expert Medicine

Dr. Purna Shankar Social Scientist
Ms. Aparna Devi

Expert Legal

Dr. Shuba Kumar Kumaraswami Social Scientist
Dr. S. Swarnalakshmi Social worker
Mr. T. Shankar Lay Public
Mr KS Ganapathy Lay Public
Dr.YDM.Prasad Expert Medicine
   
 
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