Value through Innovation23 November 2014

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 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.

Key Areas of Interest for Empagliflozin IIS-Proposals

SGLT-2 Inhibitor Mode of Action

New insights in the mode of action and biochemical pathways of SGLT-2 inhibition focusing on kidney physiology and glucose homeostasis


Cardiovascular System Effects

Effects of SGLT-2 inhibition, e.g., glucose, weight and blood pressure lowering, on overall cardiovascular risk, endothelial dysfunction, CHF


Disease prevention, disease modification and pathophysiology

SGLT-2 inhibitor effects on beta-cells, glucotoxicity and glucose homeostasis 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 Empagliflozin/Linagliptin Combination IIS-Proposals

Joint SGLT-2/DPP-4 inhibition - Mode of Action
Further understanding of the mode of action and biochemical pathways of joint SGLT-2/DPP-4 inhibition focusing on kidney physiology and glucose homeostasis

 

Cardiovascular System Effects
Effects of joint SGLT-2/DPP-4 inhibition, e.g., glucose, weight and blood pressure lowering, on overall cardiovascular risk, endothelial dysfunction, CHF

 

Disease prevention, disease modification and pathophysiology
Joint SGLT-2/DPP-4 inhibitor effects on beta-cells, glucotoxicity and glucose homeostasis in T2DM and earlier stages of the disease

 

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



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.