Vision

1. 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

Departmental Activities
Till date the department has seventy-nine (79) national and international trials to its credit. All seventy-nine trials were ICH-GCP compliant, controlled and essentially double-blinded clinical trials from all the major diabetes-focussed pharmaceutical companies across the globe. The department has also been ranked as the Global top recruiter for eight of the 75 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 it being preferred as a nodal centre by many pharmaceutical companies involved in drug trials. 

Portfolio of Current Activities of the Department

Trials Completed

1. Normopan –SF
2. Diabecon
3. Gemfibrozil
4. Creon
5. Glucobay
6. Reclide
7. Glyboral
8. Rosiglitazone
9. Repaglinide
10. Rosiglitazone
11. Combination Therapy with Human Insulin and Sulphonylureas In Indian  NIDDM Patients
12. NN2344 – 1185 – Phase II Trial
13. Cardace
14. Novomix (GCP)
15. DCBT
16. Cogent DB
17. Novolet
18. Sit-100
19. Hyponidd
20. Doxasozin
21. Diamicron MR
22. F3Z – IN-IONL
23. Human Insulin Zinc Suspension (Lente)
24. GOURDIN
25. NN622-1343
26. ASDIAB
27. CL3-21403-010-IND
28. BI/PM/001/IND
29. BI/NPH/001/IND
30. Clinical Evaluation of the Efficacy and Safety of Atorvastatin+ Fenofibrate   
31. NMITLI-DM-FN-01
32. F3Z-IOOI-IOL
33. LY333531Treatment for Symptomatic Peripheral Neuropathy in Patients with Diabetes
34. A Cross-sectional Study to assess the Correlation between The Quantitative testing of Vibration sensation and Nerve Conduction studies of Peroneal and Tibial  Nerves in Patients With Diabetes mellitus
35. A Double-blind, Proof of Concept Trial of the use of  Pegvisomant to Reduce Urinary Albumin Excretion In Type 2 Diabetic patients treated with Angiotensin  Convertase Inhibitors/ Angiotensin
36. A multicenter, randomized,double-blind study to compare the effects of 24  weeks treatment With LAF 237(50 mg qd, 50 mg bid or 100 mg qd) to placebo in  drug naïve patients with Type 2 Diabetes (Core Study).
37. A 52 week Extension to A Multicenter, Double-Blind, Randomized, Active Controlled, parallel Group Study to Compare the Effect of 12 weeks Treatment  With LAF 237  50 mg BID to 50 mg OD in Patients with Type 2 Diabetes with HbA1C 9-11%(Extension Study)
38. Protocol CLAF 237A239 & CLAF237A2329E1: A multicenter, double- blind, randomized, active controlled, parallel group study to compare the effect of 12 weeks treatment with LAF 237 50 mg BID  to 50 mg OD in patients with Type 2 Diabetes with HbA1c-9-11%
39. Evaluation of Efficacy and Safety of insulin Glargine (rDNA origin) for control of Hyperglycemia in Subjects with Type 2 Diabetes mellitus(Phase III study)
40. DREAM
41. EPIDREAM
42. A 90-day, Multicenter, Double-Blind, randomized, Add-On study to Evaluate the safety and Efficacy of Low and High Dose of Oral Insulin/4-CNAB Tablets versus Placebo in subjects With Type 2 Diabetes Mellitus who have Inadequate  Glycemic Control with Metformin Monotherapy.
43. Safety and Efficacy of Exenatide in patients with Type 2 Diabetes using Metformin or Sulphonylureas and Metformin
44. A Multicenter, Double- Blind, Randomized, Placebo-Controlled Study of MK-0431 in Patients with Type 2 Diabetes mellitus Who have Inadequate  Glycemic Control
45. Randomised trial on the effect of Atorvastatin versus Fenofibrate on serum lipid profile among type 2 diabetic patients-– Fenofibrate and Atorvastatin  In Treating Hyperlipidaemia [FAITH] trial.
46. Impact of Lipid Lowering by Rosuvastatin and Fenofibrate in patients with Diabetic Retinopathy (ROSUVASTATIN)
47. Treatment of peripheral Neuropathy in Patients with Diabetes( LY333531)
48. A Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Determine the Efficacy and Safety of SYR 110322 (SYR-322) When Used in Combination with Metformin in Subjects with Type 2 Diabetes
49. A Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to  Determine the Efficacy and Safety of SYR 110322(SYR-322) when used  in  Combination with Sulfonylurea in Subjects with Type 2 Diabetes
50. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR 110322(SYR-322)When Used in Combination with Pioglitazone in Subjects with Type 2 Diabetes
51. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR 110322(SYR-322)When Used In Combination with Insulin in Subjects with Type 2 Diabetes
52. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine The Efficacy and Safety of SYR 110322 (SYR-322) Compared with Placebo in Subjects with Type 2 Diabetes
53. A Multicenter, Randomized, Double–Blind, placebo-controlled study to determine the efficacy and safety of the combination of SYR –322 (SYR110322) and Pioglitazone HCL (ACTOS®), in subject with Type 2 Diabetes
54. A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Study to  Determine the Efficacy and Safety of the Combination of SYR-322 (SYR110322)and Pioglitazone HCl (ACTOS®), in Subjects with Type 2 Diabetes
55. Evaluation of Diathea in patients with type-2 diabetes mellitus
56. ADVANCE
57. A Randomised double-blind,active-controlled,Multicenter study to compare the effect of 24 weeks treatment with a fixed combination therapy of Vidagliptin and Metformin to the Individual Monotherapy components in drug naïve patients with Type 2 Diabetes             
58. A single centre, open, comparative study of the importance of effective pre-prandial and post- prandial hyperglycemic Control on pre-clinical atherosclerotic markers In Type 2 Diabetic subjects.
59. NN1998-1682 – Inhaled Pre-prandial human insulin with the AERxiDMS  plus Glimepiride versus rosiglitazone plus Glimepiride in type 2 diabetes: a phase 3a, 26-week, open-label, multicenter, randomized, parallel trial to investigate efficacy.
60. A randomized, double-blind study comparing the efficacy and safety of a  Fixed  combination of Fenofibrate and Metformin vs Metformin alone in  Patients with type   2 diabetes mellitus and dyslipidemia not appropriately
61. Protocol H7U-MC-IDAV(a)A Phase 3,Open-Label,Parallel Group to Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation  Powder(HIIP)
62. A Phase 3,Open-Label, parallel Group Treatment Concordance Study to Compare Insulin Use and Its Effect on Glycemic Control in patients with Type 2 Diabetes mellitus: Two Populations with Different Insulin Treatment  Options
63. AGI-1067 As a Novel Antidiabetic Agent Evaluation Study(ANDES)
64. An Open-Label,Multi-Center,Randomized,Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAjectä-06 J and Regular Human Insulin in Patients With Type 1 Diabetes Mellitus
65. Dream On
66. Epidream On
67. ACTIV X 0104-003 – A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of KRP-104 in patients with Type 2  Diabetes Inadequately Controlled on Metformin
68. Compare to Preprandial Injectable Insulin in patients with Type 1 Diabetes.              
69. The Indian POLYCAP (Quintapil)- A randomized double-blind controlle  trial of the efficacy and safety of POLYCAP versus its components in subjects with at least one additional cardio-vascular risk factor and its related documents Controlled with a statin ( C LF23 0121 06 01)
70. A Multicenter, Randomized, Double-Blind, placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin BMS 477118 in combination with Thiazolidinedione with Type2 Diabetes Who Have Inadequate Glycemic Control Thiazolidinedione Therapy Alone
71. Liraglutide Effect and Action in Diabetes(LEAD-2):Effect on glycemic control after Once daily administration of Liraglutide in combination with Metformin versus Metformin Monotherapy and Glimepiride combination therapy in subjects with Type 2 Diabetes A six-month double-blind, double-dummy, randomized,  active control, parallel-group, Multi national trial with an 18 months trial  extension period
72. Investigation of safety and efficacy of five doses of NNC 0113-0217 versus placebo and open-label liraglutide, as add on therapy ,in subjects diagnosed with type 2 diabetes currently treated with metformin or controlled with diet and exercise. A 12 week multi centre, multi-national, double-blind placebo-controlled randomized, nine armed parallel group, dose finding trial
73. The PERSISTENT Trial: A ProspectivE Randomized Trial Comparing InSulin ProTamine SuspEnsion to Insulin GlargiNe in patients with Type 2 Diabetes on Antihyperglycemic Medications
74. The COMPLETE T2D Trial: COMParison of Insulin Lispro Protamine Suspension and DETEmir in Type 2 Diabetes Mellitus
75. A Multicenter, Randomized, Double- Blind, Active- Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in combination with Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and To Metformin IR Monotherapy in subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control