IDRF operates as a Site Management Office (SMO) for the conduct of Clinical Trials in Diabetes / Cardiovascular Disease / Hypertension.

Salient Features of the SMO

  • Well equipped local lab facility
  • Experienced Site Coordinators
  • Facility to conduct Phase –II / III / IV Trials
  • Secure Drug Storage Area
  • Secure Document Storage Area
  • Archival Facility
  • Electronic Medical Records
  • Facility for EDC / IVRS
  • High – Speed Internet
ORIGIN Study

ClinicalTrials.gov Identifier: NCT00069784

A Multicenter, Multinational, Randomized, 2x2 Factorial Design Study To Evaluate The Effects of LANTUS (Insulin Glargine ) Versus Standard Care And Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People with Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes mellitus.

Study Start Date: Dec 2007
Study End Date: Nov 2011

GRACE Study

A Multicenter, International, Randomized, 2x2 Factorial Design Study To Evaluate The Effects of LANTUS (Insulin Glargine ) Versus Standard Care And Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People with Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes mellitus: The ORIGIN Trial (Outcome Reduction with Inital Glargine Intervention)

The objective of the study is to demonstrate a reduction of atherosclerosis (thickening of the blood vessels) with Lantus and/or Ethyl esters of Omega-3-fatty acids as measured by carotid (one of the blood vessel in neck) intimal thickness in patients with Impaired fasting glucose (IFG), Impaired Glucose Tolerance (IGT) and early Type 2 Diabetes Mellitus.

Study Start Date: Jul 2007
Study End Date: Nov 2011

STEP Study

A Multicentre, Randomised, Double-Blinded Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118)In combination with Thiazolodidione Therapy in subjects with type 2 diabetes who have inadequate glycaemic control on Thiazolodidione therapy alone.

Start Date: Jul 2007

End Date: July 2009

SIBA Study

A 26 week Randomized, controlled, open-label, multicentre, multinational, Three-arm, Treat to target trial Comparing Efficacy and Safety of three different Dosing Regiments of Either NN1250 or Insulin Glargine with or without combination with OAD treatment, in Subjects with Type 2 Diabetes Mellitus.

ClinicalTrials.gov Identifier: NCT01006291

Start Date: Nov 2009
Stop Date: Jan 2011

IDMPS WAVE 5 Study

An international, multicentric study to assess current practices in the management of type 1 and type 2 diabetes mellitus.

TIDE Study

Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) a Multicenter Randomized Double-blind Placebo-controlled trial of a Thiazolidinedione or placebo and of Vitamin D or placebo in people with type 2 diabetes at a risk for cardiovascular disease.

Start Date: Apr 2010

End Date: Jan 2011

VERIFY Study

A 5-year study to compare the durability of glycemic control of a combination regimen with vildagliptin and metformin versus standard of care monotherapy with metformin, initiated in treatment-naive patients with type 2 diabetes mellitus.

Start Date: Dec 2012

End Date: Dec 2019

ORGINALE Study

The ORIGINALE (Outcome Reduction with an Initial Glargine Intervention and legacy effects)  Follow-up  Study

Start Date: Feb 2013

End Date: Jun 2014

VILDAGLIPTIN Study

A multicenter, randomized, open-label study on comparison of Pancreatic Beta Cell recovery and perseveration in Type 2 diabetic patients treated with a DPP-4 inhibitor (vildagliptin) and Metformin.

Start Date: Dec 2013

End Date: Jan 2019

LANPLUS Study

A Prospective, multicentric, randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog Glargine plus Glulisine with Premixed Insulin in Adult Patients with Type 2 Diabetes Mellitus.

Start Date: Dec 2016

End Date: Jan 2019

TRESIBA Study

A multicentre, prospective, open-label, single-arm, non-interventional, post-marketing surveillance (PMS) study of Tresiba (Insulin degludec) to evaluate long term safety and efficacy in patients with Diabetes Mellitus in routine practice in India.

Start Date: Dec 2015

End Date: Aug 2017

RYZODEG Study

A multi-center, prospective, open-label, single-arm, non-interventional, post-marketing surveillance (PMS) study of Ryzodeg (IDegAsp) to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practices in India.

Start Date: Feb 2016

End Date: Sep 2017

CANAGLIFLOZIN Study

Retrospective observational study to observe clinical effectiveness of Canagliflozin 300 mg containing treatment regimens in Indian type 2 diabetes patients with BMI>25 kg/m2, in the real-world clinical setting.

Start Date: Sep 2018

End Date: Jan 2020