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Center for Global Research Data

Stratification of SGLT2 inhibitor glucose lowering therapy in Type 2 diabetes

Lead Investigator: John Dennis, University of Exeter Medical School
Title of Proposal Research: Stratification of SGLT2 inhibitor glucose lowering therapy in Type 2 diabetes
Vivli Data Request: 5959
Funding Source: Government Funding (Medical Research Council, UK)
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Type 2 diabetes affects over 350 million people. Good control of blood glucose (sugar) with appropriate lifestyle 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 HbA1c change and side effects for glucose lowering treatments called sodium–glucose cotransporter 2 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
4. 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.

Requested Studies:

A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.
Sponsor: Boehringer Ingelheim
Study ID: NCT00736099
Sponsor ID: 1218.40

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
Sponsor: Boehringer Ingelheim
Study ID: NCT01159600
Sponsor ID: 1245.23

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control
Sponsor: Boehringer Ingelheim
Study ID: NCT01164501
Sponsor ID: 1245.36

A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Trial of BI 10773 (10 and 25 mg Administered Orally Once Daily) Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite a Background Therapy of Pioglitazone Alone or in Combination With Metformin
Sponsor: Boehringer Ingelheim
Study ID: NCT01210001
Sponsor ID: 1245.19

A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 10773 and Sitagliptin Administered Orally Over 24 Weeks, in Drug naïve Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Diet and Exercise
Sponsor: Boehringer Ingelheim
Study ID: NCT01177813
Sponsor ID: 1245.20

A Randomised, Double-blind, Placebo Controlled, Parallel Group 24 Week Study to Assess the Efficacy and Safety of BI 1356 (5 mg) in Combination With 30 mg Pioglitazone (Both Administered Orally Once Daily), Compared to 30 mg Pioglitazone Plus Placebo in Drug Naive or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control.
Sponsor: Boehringer Ingelheim
Study ID: NCT00641043
Sponsor ID: 1218.15

A Randomised, Double-blind, Placebo-controled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug Naive or Previously Treated (6 Weeks Washout) Type 2 Diabetic Patients With Insufficient Glycemic Control
Sponsor: Boehringer Ingelheim
Study ID: NCT00621140
Sponsor ID: 1218.16

A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
Sponsor: Boehringer Ingelheim
Study ID: NCT00601250
Sponsor ID: 1218.17

A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg) Administered Orally Once Daily Over 24 Weeks, With an Open-label Extension to One Year (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With a Sulphonylurea
Sponsor: Boehringer Ingelheim
Study ID: NCT00602472
Sponsor ID: 1218.18

A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23
Sponsor: Boehringer Ingelheim
Study ID: NCT01289990
Sponsor ID: 1245.31

A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment
Sponsor: Boehringer Ingelheim
Study ID: NCT01167881
Sponsor ID: 1245.28

A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
Sponsor: Boehringer Ingelheim
Study ID: NCT00622284
Sponsor ID: 1218.20

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 (EXAMINE)
Sponsor: Takeda
Study ID: NCT00968708
Sponsor ID: SYR-322_402

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 (ENDURE)
Sponsor: Takeda
Study ID: NCT00856284
Sponsor ID: SYR-322_305