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Proposal 1567

Title of the Proposed Research

Stratification of SGLT2 inhibitor glucose lowering therapy in Type 2 diabetes

Lead Researcher

Andrew Hattersley

Affiliation

University of Exeter Medical Scool
(Honorary Consultant Physician (Diabetes) Royal Devon and Exeter Hospital)

Funding Source

MRC - 'MRC APBI STratification and Extreme Response Mechanism IN Diabetes - MASTERMIND' extension £3,281,749, March 2016-June 2019

Potential Conflicts of Interest

None

Data Sharing Agreement Date

23 May 2017

Lay Summary

Background

Type 2 diabetes affects over 350 million people. Good control of blood glucose (sugar) with appropriate life style and medication helps patients feel better and reduces the risks of developing diabetes complications. Current guidelines for treating patients with Type 2 diabetes list a large number of drugs without giving clear guidance on which patients should have which drug. This makes it difficult for patients and their health care professionals to know which drugs are likely to suit them best. We know that patients with Type 2 diabetes vary greatly in how well they respond to different diabetes drugs, and whether they develop side effects.

Aim

The aim of this research is to identify clinical characteristics (such as weight or blood test results) that predict treatment response and side effects for glucose lowering treatments called SGLT2 inhibitors (SGLT2I). The ultimate aim is to help doctors treat patients with Type 2 diabetes with the drug most likely to work well for them.

Objectives

Our objectives are to:

1.Identify if kidney function is associated with glucose lowering response to SGLT2I treatment
2.Identify whether clinical characteristics and blood tests associated with insulin secretion and insulin resistance are associated with glucose lowering response
3.Determine whether patients with higher glucose, and better glucose lowering response, have more side effects
5.Explore what other characteristics might help predict glucose lowering and side effects with SGLT2I

How will this research be conducted?

This research forms part of a larger national project funded by the UK government Medical Research Council, called MASTERMIND. In this study we will use information from 7 large studies where SGLT2 inhibitor treatment or comparison treatment has been previously tested in over 7000 people with Type 2 diabetes. We will test whether differences between people in these studies (for example their age, weight, or common blood test results such as kidney function) can be used to identify those who are likely to have a large reduction in blood glucose with these treatments and/or have a low risk of side effects.

We will compare results from this study with findings from other studies we are undertaking, for example other drug trials and information from patients taking these tablets as part of their normal care, so that we can be sure our findings are true and accurate. Further work to help us interpret these findings will include assessment of the potential benefits and disadvantages of targeting treatment in this way, through ongoing research in the MASTERMIND project.

How will our findings be communicated to patients and the public?

We will work with the charity Diabetes UK to communicate this research via their website, patient newsletter and social media. We will also communicate findings through presentations to patient groups and for important findings though local and national media.

Study Data Provided

BI-1218.40: Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment
BI-1245.23: Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes
BI-1245.36: Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment
BI-1245.19: Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin
BI-1245.20: Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes
TAKEDA-SYR-322_402: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome
BI-1245.31: Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes
TAKEDA-SYR-322_305: A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination With Metformin in Subjects With Type 2 Diabetes

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.