Phase 2 ,3 and 4 clinical trials are being conducted in the field of Diabetology . Multinational Research projects are being handled by us for the last 12-14 years. We have done projects for Novo Nordisk, Elli Lilly, Astra Zenica, GSK, Quintiles, PPD, Torrent Pharmaceuticals, USV Limited, India, Bayer, India, Servier, and Biocon etc,. A complete list of Research projects done by the Hospital is attached down below. Our Research Unit comprises of qualified doctors & Research Associates. All the equipment’s needed for conducting clinical trials as per GCP guidelines are available. Hospital has its own IRB which meets once in 30 days to review the current research projects & to approve new projects. Constitution of the IRB is as per GCP guidelines. Our IRB (Institutional Review Board) is recognized by DCGI (Drug controller, Govt. of India). Hospital takes up training of research associates free of cost.

Specializations

We are proud to say that Hospital has done research in all forms of Insulin ( Injectables, Nasal Spray, Inhaled Insulin & Oral ) . We are also evaluating Glucose estimation by non invasive techniques for several companies. Most of the Multicentric international Cardiovascular Out come trials (CVOT’s) as per regulatory agencies requirement are being conducted here.

Participation in Clinical Trials is purely voluntary and patients are encouraged to discuss in detail about participation in research activities of the Hospital. Science progress through research & voluntary patient participation is solicited.

• NN622 - Ragagitazaar in uncontrolled diabetes.
• Sponsor - NovoNordisk and CRO: Novo Nordisk

• Studies in the field of proteomics and genomics.
  Sponsor: Biocon

• DREAM and EPIDREAM – Diabetes Reduction Assessment with medications (Ramipril and Rosiglitazone) – a 5 year follows up.
  Sponsor: PHRI

• STARR – Measurement of INTIMA – MEDIA thickness using Carotid Ultrasound.(A DREAM substudy).
  Sponsor: PHRI

• Origin – Outcome reduction with Initial Glargine Intervention.
  Sponsor: Sanofi Aventis and CRO: Sanofi Aventis

• GRACE – Measurement of INTIMA – MEDIA thickness using Carotid Ultrasound (A ORIGIN substudy)
  Sponsor: Sanofi Aventis and CRO: Sanofi Aventis

• Worked on the Insulin studies – Long acting and Intermediate acting Insulins.
  Sponsor: Biocon

• GALIDA STUDIES – GALLANT 8, Gallant 14, G-Plus and GALLEX – Tesaglitazaar in type II Diabetes patients with dyslipidemia suboptimally controlled on OHA’s.
  Sponsor: Astrazeneca

• Evaluation of the safety and effects of DHEA (dihydroepiandrosterone) with Niacin in the treatment of patients with primary hypercholesterolemia.
  Sponsor: DHEA and CRO: Manipal Accunova

• ASCEND – To access the effect of endothelin receptor antagonist avosentan on time to doubling of serum creatine, endstage renal disease or death in patients with Type II Diabetes Mellitus and Diabetic nephropathy.
  Sponsor: Speedel and CRO: Quintiles

• Evaluation of Efficacy and Safety of Insulin Lispro.
  Sponsor: Wockhardt

• M102-20509 – Working with Metaglidasen in the treatment of Type II Diabetes in patients suboptimally controlled on Insulin.
  Sponsor: Metabolex and CRO: Icon

• IDAU – Working with Human Insulin Inhalation Powder (HIIP) compared to preprandial injectable insulin in Insulin naïve Type II Diabetes Mellitus.
  Sponsor: Eli-lilly and CRO: Eli-lilly

• IDBA – Evaluation of the efficacy and safety of human insulin inhalation powder (HIIP) in patients with Type II Diabetes Mellitus treated with once daily insulin glargine.
  Sponsor: Eli-lilly and CRO: Eli-lilly

• NN1998-1682 – Working with inhaled pre-prandial human insulin with AERX device.
  Sponsor: Novo Nordisk and CRO: Novo Nordisk

• Working with CB-1R inverse agonist (Cannabinoid 1 receptor agonist) in Overweight and Obese patients with Type IIDM.
• CV 181 013 – A Multicenter, Randomized, Double-Blind, Placebo Controlled,            Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS – 477118) In Combination with Thiazolidinedione Therapy in subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone.
  Sponsor: BMS and CRO: Icon
• CV 181-039 – 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.
  Sponsor: BMS and CRO: Icon

• Evaluation of safety and efficacy of add on intranasal insulin spray in Type II DM patients on oral antidiabetic agents.
  Sponsor: Biocon and CRO: Clinigene

• IN 105 – Phase I – evaluation of “Food on the pharmacokinetic and pharmacodynamics of oral insulin in Type II DM patients.
  Sponsor: Biocon and CRO: Clinigene

• Hypoglycemia in sulphonylurea treated Type II DM subject undergoing Ramadan Fasting.
  Sponsor: Merck Inc. and CRO: Syreon
• EFC 6015 – A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter study followed by an extension assessing the efficacy and safety of AVE0010 on top of sulfonylurea in patients with type 2 diabetes not adequately controlled with sulfonylurea.
  Sponsor and CRO: Sanofi Aventis

• EFC 6017 – A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week main treatment period and an extension assessing the efficacy and safety of AVE0010 on top of pioglitazone in patients with type 2 diabetes not adequately controlled with pioglitazone.
  Sponsor and CRO: Sanofi Aventis

• CLG026/BD001/DM/VJ/2007 – An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAJECT™ and Regular Human Insulin in Patients with Type 1 Diabetes Mellitus-06J.
  Sponsor: Biodel and CRO: Clinigene

• L2T3 – Target glycemic control and the incidence of documented symptomatic Hypoglycemia in insulin naïve subjects with type 2 diabetes failing on oral hypoglycemic agents (s) and treated with Lantus ® (insulin glargine) or Levemir® (insulin detemir): multicenter, multinational, randomized, open-label, comparative, parallel-group study.
  Sponsor: Sanofi Aventis and CRO: Sanofi Aventis

• EFC10007 – A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Asses Glycemic Control with Rimonabant in Comparison with Glimepiride over 1 Year in Overweight/Obese Type 2 Diabetic Patients Not Adequately Controlled with Metformin.
  Sponsor and CRO: Sanofi-Aventis

• ECS00107 – “A Multicenter, single -Blind, Active And Placebo-Controlled, Parallel-Group Randomized Study Of Two Dosing Regimens Of Enteric Coated Sevelamer In Patients with Mild To Moderate Hypercholesterolemia”
  Sponsor: Genzyme Corporation and CRO: Manipal Accunova

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• XTL B07 – 001 – A Double-blind Randomized, Placebo-controlled, Parallel, Multicenter Study of the Safety and Efficacy of Two Dosages of Bicifadine SR in Adult Outpatients with Chronic Neuropathic Pain Associated with Diabetic Peripheral Neuropathy.
  Sponsor: XTL development and CRO: GVK Bio

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• M102-20814 – “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”.
  Sponsor: Metabolex and CRO: Pharm Olam.

• 46 – A Phase III randomized, double-blind, placebo-controlled parallel group study to compare the efficacy and safety of twice daily administration of the free combination of BI 1356 2.5 mg + Metformin 500 mg, or of BI 1356 2.5 mg + Metformin 1000 mg, with the individual components of Metformin (500 mg or 1000 mg, twice daily), and BI 1356 (5.0 mg, once daily) over 24 weeks in drug naïve or previously treated (4 weeks wash-out and 2 weeks placebo run-in) type 2 diabetic patients with insufficient Glycemic control.
  Sponsor: Boehringer Ingelheim Pharma GmbH & Co.KG and CRO: Quintiles

• Rosi-DSE – Tissue Doppler imaging and quantification of left and right ventricular myocardial function in type II diabetes mellitus treated with rosiglitazone.
• 52 – A phase III randomised, double-blind parallel group extension study to investigate the safety and efficacy of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46.
  Sponsor: Boehringer Ingelheim Pharma GmbH & Co.KG and CRO: i3 Research.

• 62 – A randomized, double-blind , placebo controlled,3 parallel group efficacy and safety study of linagliptin 2.5 mg twice daily versus 5mg once daily over 12 weeks as add on therapy to a twice daily dosing regimen of Metformin in patients with type 2 diabetes mellitus and insufficient Glycemic control”.
  Sponsor: Boehringer Ingelheim Pharma GmbH & Co.KG and CRO: Manipal Accunova

• D1680C00006 – A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled, Phase III study to Evaluate the Efficacy and Safety of Saxagliptin in combination with Metformin in Adult Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Therapy in addition to Diet and Exercise.
  Sponsor: Astrazeneca and CRO: Neeman

• CLMF237A2302 – A randomized, double-blind, active-controlled, multicenter study to compare the effect of 24 weeks treatment with a fixed dose combination therapy of vildagliptin/metformin to the individual monotherapies in drug naïve patients with type 2 diabetes.
  Sponsor: Novartis and CRO: Novartis

• SYR-322-INS-011 – A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination with Insulin in Subjects with Type 2 Diabetes.
  Sponsor: Takeda and CRO: PPD

• SYR-322-OLE-012 A Long Term, Open-Label Extension Study to Investigate The Long- Term Safety of SYR110322 (SYR-322) in Subjects with Type 2 Diabetes.
  Sponsor: Takeda and CRO: PPD

• IN105-CT3-004-08 – A Multicenter, Randomized, Double-Blind, Placebo Control Study of IN-105 tablets (oral insulin) in Patients with Type 2 Diabetes Mellitus who have inadequate Glycemic Control on Optimal doses of Extended Release Metformin Tablets.
  Sponsor: Biocon and CRO: Clinigene

• 0941-007-00 – A Phase IIb/ III, Multicenter, Randomized, Double-Blind Study, Placebo Controlled Dose-Range Finding Clinical Trial of Mk 0941 in a Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin.
  Sponsor: Merck and co and CRO: Clinigene

• 70971-004 – “Effects of Naturlose (Tagatose) on Glycemic Control and Safety of Naturlose Over one Year in subjects with Type 2 Diabetes under Diet Control and Exercise”.
  Sponsor: Spherix and CRO: Manipal Accunova

• CARISNPP2003 – A randomized, double-blind, Placebo and Active-controlled study of carisbamate in the treatment of Neuropathic pain in Diabetic peripheral neuropathy followed by a Blinded Extension phase.
  Sponsor and CRO: J & J

• EDGE – A multinational, multicenter, post – marketing, prospective observational cohort study to access the profile of vildagliptin and the fixed – dose combination of vildagliptin/Metformin relative to comparator oral antidiabetic drugs in patients with type II diabetes in a real-world setting.
  Sponsor: Novartis

• AMR-01-01-0016 – A Phase3, Multi-center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study With an Open-Label Extension to Evaluate the Efficacy and Safety of AMR101 in Patients With Fasting Triglyceride Levels ≥ 500mg/dl and ≤ 2000mg/dl.
  Sponsor: Amarin Pharma and CRO: Medpace

• DUT-MD-304 – A PhaseIII, 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 Pioglitazone.
  Sponsor: Forest Research and CRO: Parexel

• DUT – MD-303 – 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.
  Sponsor: Forest Research and CRO: Parexel

• SYR322_MET302 – A multicenter, Double-Blind, Placebo-Controlled study to Determine the Efficacy and safety of Alogliptin plus Metformin, Alogliptin Alone or Metformin Alone in subjects with type 2 Diabetes.
  Sponsor: Takeda and CRO: Siroclin pharm

• LG-DPCL005 – A multicenter, multinational, randomized, placebo-controlled, parallel group, double-blind, Phase III trial to evaluate the efficacy and safety of LC15-0444 in patients with type II diabetes.
  Sponsor: LG lifesciences and CRO: LG lifesciences

• LG-DPCL006 – A multicenter, multinational, randomized, active-controlled, parallel group, double-blind, Phase III trial to evaluate the efficacy and safety of LC15-0444 compared with sitagliptin added to ongoing Metformin therapy in patients with type II diabetes adequately controlled with Metformin alone.
  Sponsor: LG lifesciences and CRO: LG lifesciences

• 082-00 – Randomized, placebo controlled clinical trial to evaluate CV outcomes after prescribed with sitagliptin in patients with Type II and inadequate glycemic control on mono/dual combination OHA’s.
  Sponsor: Merck (TECOS) and CRO: Clinsys.

• TIDE – Thiazolidinedione Intervention with Vitamin D Evaluation (“TIDE”): A Multicenter, Randomized Double-Blind Placebo-Controlled Trial of a Thiazolidinedione (TZD) or Placebo and of Vitamin D or Placebo In People With Type 2 Diabetes at Risk For Cardiovascular Disease (Protocol Number AVD111960).
  Sponsor: GSK and CRO: Quintiles

• NC25113 – “A randomized double blind, placebo-controlled clinical trial to assess the effects of taspoglutide (RO5073031) on cardiovascular outcomes in subjects with inadequately controlled type 2 diabetes and established cardiovascular disease”
  Sponsor: Roche and CRO: Quintiles.

• MK-0431– An Open-Label, Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin with Sulfonylurea Treatment in Patients with Type 2 Diabetes During Ramadan Fasting
  Sponsor: MSD Pharmaceutical Pvt. Ltd. CRO: SIRO

• 28431754DIA3008 – “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”
  Sponsor: Janssen Research & Development, LLC and CRO: George Clinical

• P2202/47/10 -“A Phase II, Randomized, Double blind, Placebo-Controlled, Dose-Ranging, Two-Staged, Fixed Design Study to Evaluate the Efficacy, Safety, Tolerability and pharmacokinetics of P2202 in Overweight/Obese Patients of Type 2 Diabetes Mellitus Inadequately Controlled on Metformin, Sulfonylurea, or Both”.
  Sponsor: Piramal Life Sciences Limited and CRO: Pharmanet

• ITC Limited – Corporate Division – “Comparative proof of concept study on taste perception”
  Sponsor and CRO: ITC

• 25 – “A Phase III Multicenter, International, Randomized, Parallel Group, Double Blind Cardiovascular safety study BI 10773 (10 mg and 25 mg administered orally once daily) compared to usual care in type 2 Diabetes Mellitus Patients with Increased cardiovascular risk.”
  Sponsor: Boehringer Ingelheim and CRO: SIRO

• CT/P015/CMR/2012/02_02 – “Safety and efficacy of TRC150094 in treatment of cardio-metabolic risk in overweight/obese diabetic subjects with dyslipidemia.”
  Sponsor: Torrent and CRO: SIRO

• SK-0403-2.01US – “A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo and Active Controlled Phase2 Dose Finding Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well controlled on Metformin Therapy”
  Sponsor: KOWA Research Institute, INC. and CRO: Medpace

• Mk-0431-262 – “An Open-Label, Randomized Naturalistic study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin with Sulfonylurea Treatment in Patients with Type 2 Diabetes During Ramadan Fasting.”
  Sponsor: MSD Pharmaceuticals Pvt. Ltd. And CRO: SIRO

• IN105-CT1-005-09 – “An Open Label, Multicenter, Non-Randomized, Active controlled, Single Dose escalation study to evaluate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of IN-105 under fed conditions in patients with Type 1 Diabetes Mellitus”
  Sponsor: Biocon and CRO: Clinigene

• 09.002.01.1PROT – “A multi-centric, prospective, randomized, double blind study to evaluate the safety and efficacy of 2mg and 4mg of ZYH1 compared to placebo in hypertriglyceridemia with type II diabetes not controlled with Atorvastatin therapy.”
  Sponsor and CRO: Cadila Healthcare Limited

• BI 1218.74 – “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. The CAROLINA Trial”
  Sponsor: Boehringer Ingelheim and CRO: Manipal Acunova Limited

• 28431754DIA3010 – “A Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type II Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy.”
  Sponsor: Janssen Research & Development, LLC and CRO: George Clinical

• GLP114130 – “A Randomized, Double-Blind, Active-Controlled, Parallel Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Sitagliptin in subject With Type 2 Diabetes Mellitus with Renal Impairment.”
  Sponsor: GlaxoSmithKline and CRO: PPD

• MK-0431- 063 –“A Multicentre, Randomized, Double-Blind Study to Evaluate the  Efficacy and Safety of Sitagliptin Versus Glipizide in Patients with type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have inadequate Glycemic Control.”
  Sponsor: Merck and CRO: Paraxel

• LANTUC06496 – “Importance of Long-Term Follow-up of the ORIGIN Participants: The ORIGINALE (ORIGIN And Legacy Effects) Follow-up Study.”
  Sponsor: PHRI and CRO: David Braley Cardiac, Vascular and Stroke Research Institute

• F3Z-MC-B010 (b) – “Prospective Observational Study Protocol F3Z-MC-B010 (b): A Multinational Observational Study Assessing Insulin Use: understanding the challenges associated with progression of therapy – The MOSAIc Type 2 Diabetes study
  Sponsor: Eli Lilly and CRO: Quintiles

• D1680C00003 – “A Multicenter, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients with Type 2Diabetes”
  Sponsor and CRO : Astra Zeneca Pharma India Ltd.

• India JD Program – “A multicentric, randomized, integrated disease management program to compare structured care using the JADE portal versus usual care using the DIAMOND portal on control of risk factors in type 2 diabetes patients.
  Sponsor: Asia Diabetes Foundation (ADF) and CRO: MSD

• BI 1218.74 – “A multicentre, International, Randomized, parallel group, Double blind study to evaluate”
  Sponsor: BoehringerIngelheimPharma GmbH & Co. CRO: Manipal Acunova Limited

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• 28431754DIA3008 – “A Randomized, Multicenter, Double-Blind, Parallel, placebo-Controlled Study to the Effects of JNJ-28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus.”
  Sponsor: Janssen Research & Development LLC CRO: George Clinical.

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• BI 1245.25 – A Phase III Multicenter, International, Randomized, Parallel Group, Double Blind Cardiovascular safety study of BI 10773 (10 mg and 25 mg administered orally once daily) compared to usual care in type 2 diabetes Mellitus Patients with Increased cardiovascular risk.
  Sponsor: BoehringerIngelheim CRO: SIRO

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• CT/P015/CMR/2012/02_02 – “Safety and efficacy of TRC150094 in treatment of cardio-metabolic risk in over weight/obese diabetic subjects with dyslipidemia”
  Sponsor: Torrent CRO: SIRO.

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• Vitamin-D – EFFICACY OF VITAMIN D SUPPLEMENTATION ON REDUCTION OF CARDIOMETABOLIC RISK IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND DYSLIPIDEMIA
  Sponsor: RSSDI

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• NEM CGM14-8/01 – A Multicentre clinical Investigation Plan to Investigate the Performance of the CGM-Watch in an Adult Population with Type 1 and 2 Diabetes Mellitus.
  Sponsor: NemauraPharma Ltd CRO: Max Neeman International

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• D1690R00002 – DISCOVER: Discovering Treatment Reality of Type 2 Diabetes in Real World Settings
  Sponsor:AstraZeneca CRO: Quintiles

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• INDEPENDENT – Integrating Depression and Diabetes Treatment (INDEPENDENT) Study
  Sponsor: National Institute of Mental Health, National Institutes of Health, USA
  CRO: Madras Diabetes Research Foundation, Chennai, India.

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• IPCA/HCQS/PIV-14 – Evaluation of Safety and Efficacy of Hydroxychloroquine Sulfate as an Adjunct to Diet and Exercise to Improve Glycemic Control in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea + Metformin Combination
  Sponsor: Ipca Laboratories Limited CRO: Ipca Laboratories Limited

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