Value through Innovation10 February 2016

Investigator-Initiated Study Program for Diabetes

The Investigator-Initiated Study (IIS) Program for Diabetes aims at advancing the delivery of quality healthcare by supporting investigator original research that will enhance the understanding of disease entities and their treatment. This program is open to all academic and community-based physicians and researchers worldwide who are interested in conducting their own research.

  • Boehringer Ingelheim works to discover and develop innovative, safe and effective ways to treat and prevent some of the world's most challenging diseases. The Boehringer Ingelheim program for investigator-initiated studies in diabetes was established to provide study drug and/or possible financial support for independent clinical research sponsored by the investigator.

  • The goal of this study program is to expedite the evaluation and approval of requests for unsolicited research support from physicians and other qualified researchers. Independent investigator original research will be supported to enhance the understanding of diabetes.

  • In accordance with ICH E6-Good Clinical Practice the sponsor-investigator is responsible for planning, design, execution, analyses, and disclosure of study relevant information for the IIS. This is to ensure an independent research approach.

Key Areas of Interest for Empagliflozin IIS-Proposals

Exploring the Effects of Empagliflozin on the Cardiovascular System
New insights in the mode of action, potential pleiotropic effects, biochemical pathways and clinical effects of SGLT-2 inhibition with empagliflozin focusing on micro and macro vascular function, heart failure, cardiovascular risk and other diabetic complications in T2DM and earlier stages of the disease

 

Exploring the Effects of Empagliflozin on the Renal System
New insights in the mode of action, potential pleiotropic effects, biochemical pathways and clinical effects of SGLT-2 inhibition with empagliflozin focusing on kidney pathophysiology in T2DM and earlier stages of the disease

 

SGLT-2 Inhibition with Empagliflozin in Combination with Other Mode of Actions
Investigation of SGLT-2 inhibition effects of empagliflozin, e.g. in combination with DPP-4 inhibitor linagliptin, on metabolic control and the cardio-renal-axis in T2DM and earlier stages of the disease

 

Not to restrict scientific creativity other research focus areas will be considered as well.

Key Areas of Interest for Linagliptin IIS-Proposals

Cardiovascular system effects

Exploring biological pathways impacting the cardiovascular system

Applying new investigational laboratory and other diagnostic approaches

Effects of no-incretin DPP-4 substrates


  • Renal system and micro vascular effects

Exploring pathophysiology of the renal system with emphasis on incretin effects

Applying new investigational laboratory and other diagnostic approaches

  • Effects of no-incretin DPP-4 substrates

DPP-IV Inhibition and incretin effects

Pathophysiology and metabolic pathways focusing on a- and b-cell function

Clinical experience in special populations, e.g. in terms of compliance/adherence

Effects on various tissues and different target organs


Not to restrict scientific creativity other research focus areas will be considered as well.

  

  

DOWNLOADS –Templates for IIS-Proposal Submission and Contact

 

“IIS-Abbreviated Study Outline“– As a first step this template may be used as a summary of the scientific medical rationale and objectives. It is intended to check for potential similar studies in the linagliptin IIS grant program before completing the IIS full study outline proposal.

 

"IIS-Study Outline”– Full proposal form including scientific medical rationale and objectives, complete study design, biometry and study management and administration topics.

Please fill out the relevant form and send it to Boehringer Ingelheim:
Info.IIS-Diabetes@boehringer-ingelheim.com

After we received your online-application a local representative of 
Boehringer Ingelheim will contact you.