Research Centre and Facilities:
The research wing comprises of dedicated workstations for CRCs with individual computers that have broadband internet connections, dedicated fax line, scanning and STD/ISD facilities. A conference/monitoring room will be used for all monitoring visits, review meetings, the Ethics Committee (EC) meetings. The conference room is air-conditioned and has a LED projector for giving presentations, with a broadband internet connection and an STD/ISD line.
The research wing is situated on the first floor of the complex with all the facilities available for conducting research as per ICH- GCP standards and Schedule-Y.
The research wing has a secure drug storage room with a locked door which has biometric fingerprint restricted access, 24-hour air – conditioning facility with temperature surveillance and individualized locked cupboards for storing Investigational Products (IP). The drug storage room also has a refrigerator, minus 20°C and minus 70°C deep freezer.
Prof(Dr.)L. Sreenivasa Murthy is Part of Landmark Trials like HOPE-3, Clarify, BEGIN-BOOST, Degludec, ELIXA, EFC etc
Whenever there is need to store IPs of two different trials ina single unit (Refrigerator/Deep freezer) necessary precautions will be taken to maintain the confidentiality of the IP’s and to avoid misuse, by compartmentalizing them with thermocol, which will be clearly labelled. All instrumentswill be calibrated twice a year and calibration certificates maintained in separate file in PI’s Chamber. The entire unit is backed by 24-hour on-line UPS & Back up Diesel Generator of capacity 63 kva .
The Lifecare hospital and Research Centre was inspected by US FDA in 2012 without major findings!
World’s first ever CANADIAN HEALTH AUTHORITY inspection (outside Canada) was conducted at LIfecare hospital in 2018.
we have faced DCGI inspection from Government of India and many sponsor audits!
Research & Clinical Trials
Sentinel surveillance study
Sentinealsurveillance study, multicentric national study, who sponsored-Co investigator.
Sitatliptin versus Glipizide
Protocol Id: MK-0431-063-00 Protocol Title: A Multicenter, Randomized, Double-Blind Study to evaluate efficacy and Safety of Sitatliptin versus Glipizide in Patients with Type 2 Diabetes Mellitus and Chronic Renal Insufficiency who have inadequate Glycemic control.(SIV:21-MAY-2009 COV:18-Mar-2011)
A randomised, multicentric, double blind,
A randomised, multicentric, double-blind, parallel group study to assess the efficacy, safety, and tolerability of a hidrasec 100 mg tid versus loperamide 2 mg tid in the treatment of acute diarrhoea from Dec 1999 to Jun 2001, one of the 4 centres nationwide (kimsHospital, bangalore).
Protocol Id: MK-0431-102-01
Protocol Id: MK-0431-102-01 Protocol Title: “A Multicenter, Randomized, Double blind study of the co-administration of Sitagliptin and Pioglitazone in patients with type-II Diabetes Mellitus who have inadequate Glycemic control” (SIV:04-JUN-2009 COV:10-FEB-2011).
Protocol Id: MK0941-007 -03
Protocol Id: MK0941-007 -03 Protocol Title: A phase IIb/III Multicentre Randomized Double-Blind, Placebo Controlled Dose-Range Finding Clinical Trail of MK-0941 in patients with Type 2 Diabetes Mellitus with Inadequate Glycemic control on Insulin.(SIV:28-MAY-2009 COV:08-SEP-2011).
Trial ID: NN5401-3593
Trial ID: NN5401-3593 Protocol Title: A trial comparing efficacy and safety of NN 5401 with insulin glargine, both in combination with oral antibiotic drug in subject with type 2 diabetes. (SIV: 02-MAR-2010 COV: 22-FEB-2011)
Protocol ID: SYR-322MET_302 Study
Protocol ID: SYR-322MET_302 Study Title: A Multicenter, Randomized, Double-blind, Placebo controlled Study to Determine the Efficacy and Safety of Alogliptin Alone, or Metformin Alone in Subjects with Type 2 Diabetes.(SIV:31-Mar-2010 COV:12-SEP-2011)
Protocol Title: DUT-MD-303 Study
Protocol Title: DUT-MD-303 Study Title: A phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus on background treatment with glimepiride with or without metformin (2010)
Protocol Title: DUT-MD-304 Study
Protocol Title: DUT-MD-304 Study Title: A phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus on background treatment with glimepiride with or without metformin (2010)
Protocol ID: RIT-1/AID Study
Protocol ID: RIT-1/AID Study Title: Protocol Title: “A randomised, double-blind, double-dummy, multi-centre, comparative parallel-group study to evaluate the efficacy and safety of oral daily Rifamycin SV-MMX® 400 mg b.i.d. vs. Ciprofloxacin 500 mg b.i.d. in the treatment of acute infectious diarrhoea in travellers” (SIV: 19-OCT-2010 COV: 15-NOV-2011)
Study ID:MK-0431-262
Study ID:MK-0431-262 Study Title: An Open-Label Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin with Sulfonylurea Treatment in Patient with Type 2 Diabetes During Ramadan Fasting. (SIV:21-Jun-2010 COV:07-FEB-2011)
LANTU_C_02761:
LANTU_C_02761: Superiority study of Insulin Glarigine over sitagliptin in Insulin-Naïve Patients with type 2 diabetes treated with metformin and not adequately controlled EASIE trail.
LANTU_C_02761 EXT:
LANTU_C_02761 EXT: Combination therapy of insulin glargine and sitagliptin in patients with type 2 diabetes not adequately controlled by a previous treatment with metformin and either insulin glargine or sitagliptin
LANU_C_04589:
LANU_C_04589: A 24-week, open, multicenter, comparative study of 2 strategies (including insulin glargine versus premixed insulin) for the therapeutic management of patients with type-2 diabetes failing oral agents
BI 1245.19:
BI 1245.19: A randomized, double-blinded, placebo-controlled parallel group efficacy and safety trial of BI 10773 (10 and 25 mg administered orally once daily) over 24 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control despite a background therapy of pioglitazone alone or in combination with metformin
BI1245.20:
BI1245.20:A phase III randomised, double-blind, placebo-controlled parallel group efficacy and safety study of BI 10773 and Sitagliptin administered orally over 24 weeks, in drug naïve patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet and exercise.
MB102-055:
MB102-055: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.
MB102-054:
MB102-054: A Multicenter, randomized, double-blind, placebo-controlled, parallel group, phase 3 trial to evaluate the safety and efficacy of Dapagliflozin as Monotherapy in Asian subjects with Type 2 diabetes who have inadequate Glycemic control with diet and exercise.
CLCZ696:
CLCZ696: A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction
BI1245.31:
BI1245.31: A phase III double-blind, extension, placebo-controlled parallel group efficacy and safety study of BI 10773 (10 mg and 25 mg once daily) and sitagliptin (100mg once daily) given for minimum 76 weeks (incl. 24 weeks of preceding trial) as monotherapy or with different back ground therapies in patients with type 2 diabetes mellitus previously completing trial 1245.19, 1245.20 or 1245.23
MK0431-130:
MK0431-130: A Phase III,Multicenter, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and AcarboseMonotherapy
MB102-073:
MB102-073: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trail to Evaluate the Safety and Efficacy of Dapagliflozin in subjects with Type2 Diabetes with inadequately controlled hypertension on an Angiotension –Converting Enzyme Inhibitor (ACEI) Or Angiotension Receptor Blocker (ARB)
MB102077-A
MB102077-A Multicenter ,Randomized, Double-Blind, Placebo – Controlled ,Parallel Group, Phase 3 Trail to Evaluate the safety and Efficacy of Dapaglifozin in subject with Type 2 Diabetes with Inadequately Controlled Hypertension treated with an Angiotension-Converting Enzyme Inhibitor (ACEI)or Angiotensin Receptor Blocker(ARB) and Additional Antihypertensive Medication
Trial ID NN9068-3697 :
Trial ID NN9068-3697, “ A 26 Week randomized, parallel three-arm, open label, multi-centre, multinational treat-to-target trial comparing fixed ratio combination of Insulin degludec and liraglutide versus insulin degludec or liraglutide alone, in subjects with type 2 diabetes treated with 1-2 oral anti-diabetic drugs(OAD’s).
TRIAL ID: ELIXA- EFC11319:
TRIAL ID: ELIXA- EFC11319: A randomized, double-blind, Placebo-Controlled, parallel-group, multicenter study to evaluate cardiovascular outcomes during treatment with Lixisenatide in type 2 diabetes patients after an acute coronary syndrome.
TRIAL ID:NN5401-4149
TRIAL ID:NN5401-4149: A multi-centre, prospective, open-label, single arm, non-interventional, post marketing surveillance (PMS) study of RyzodegTM (insulin degludec/insulin aspart) to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India
TRIAL ID NN95353625 :
TRIAL ID NN95353625:Efficacy and safety Semaglutide once weekly versus Insulin Glargine once dailyas add on to Metformin with or without Sulphonylurea in insulin-naïve subjects with type-2 diabetes.
TRIAL ID : EFC12382:
TRIAL ID : EFC12382: A randomized, double-blind, placebo-controlled, 2-arm parallel-group,multicenter study with a 24-week treatment period assessing the efficacy and safety ofLixisenatide in patients with type 2 diabetes insufficiently controlled with basal insulinwith or without Metformin.
TRIAL ID : DI680R00019:
TRIAL ID : DI680R00019: A Non-Interventional, Multicentre, Prospective, Observational Study to Understand usage andeffect of Saxagliptin as first add-on after metformin in Indian Type-2 Diabetes patients.
Cme Titled ‘Sudden Cardiac Death’
Completed The Cme Titled ‘Sudden Cardiac Death’ Provided By University ofNebraska Medical Center(Center For Continuing Medical Education) On 09thMay 2007.
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2748/2152, M.L.N Enclave,
16TH ‘E’ Cross Road,
8TH Main,’D’ Block
next to Corporation Bank,
Sahakara Nagar, Bangalore-560092