::Welcome to Mdrf::

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.

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

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

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.