Approved data access requests

2018: Diabetes Prevention as a Function of Baseline Diabetes Risk Assessed Using Cardio Metabolic Disease Staging in the SCALE Obesity and Prediabetes Phase 3 Randomized, Controlled Trial

Proposal number:

2018.005

Requested Studies

NN8022-1839

Lay summary

Individuals with overweight or obesity are at increased risk of type 2 diabetes mellitus (T2DM). A robust body of evidence is conclusive that weight loss is highly effective in preventing T2DM, yet weight loss is difficult to maintain with lifestyle interventions alone1. Treatment with once-daily subcutaneous liraglutide 3.0mg is a promising medication that provides sustained clinically relevant weight loss for 3 years2, and also may offer additional benefits in terms of reduced risk of T2DM.3 The ability to show links between exposure and bivariate outcome using logistic regression has limited power to show association.4 The CMDS score is classified based on bivariate criteria (i.e. you either have it or you don’t) according to National Cholesterol Education Program Adult Treatment Program III (ATP III) criteria.5 However, Metabolic Syndrome related risk for T2DM risk exists as a spectrum, and bivariate responses are not adequate to classify this range.6 This analysis uses a continuous cardiometabolic staging score (CMDS) system to assess the ability of liraglutide 3.0 mg to prevent T2DM and pre-diabetes as a function of the baseline CMDS score. The goal is to identify patients who are most likely to benefit from weight loss with the greatest benefit/risk ratio.

2018: Evaluation of the interaction between intracerebral hemorrhage location and the effect of recombinant factor VIIa treatment

Proposal number:

2018.006

Requested Studies

F7ICH-1371, F7ICH-1641

Lay summary

Intracerebral hemorrhage (ICH), bleeding into the brain from a ruptured blood vessel, is the deadliest type of stroke and has no effective treatments. We will investigate whether the location of the bleed in the brain, known to be associated with different underlying disease processes, modifies the effect of new treatments for ICH. Specifically, we will determine whether recombinant Factor VII treatment can reduce the amount of bleeding and swelling in the brain due to ICH in specific locations and improve outcomes.

2018: Prediction of the effects of liraglutide on renal outcomes in the LEADER trial

Proposal number:

2018.002

Requested Studies

EX2211-3748 (LEADER)

Lay summary

Short lay summary of the proposed research The applicants propose within the context of the Innovative Medicine Initiative BEAt-DKD (Novo Nordisk is an EFPIA partner in BEAt-DKD), to perform a post-hoc analysis of the LEADER trial. In the proposed analysis, the short term effects (± 6 months) of liraglutide on multiple renal and cardiovascular risk markers are assessed using individual data from the LEADER trial. The PRE score, a validated algorithm that translates the short term drug effect on multiple renal/cardiovascular risk markers into a predicted long term ((± 3-4 years) effect on renal/CV outcomes, will be applied on the observed short term risk marker changes in LEADER to predict the effect of liraglutide on renal outcomes.

2018: Optimal Titration in Type 2 Diabetes

Proposal number:

2018.003

Requested Studies

NN1250-3579

Lay summary

Identification of model parameters in Box-Jenkins and Stochastic Differential Equation. The models are to be used for designing optimal titration protocols for type 2 diabetic patients and should express the relation between insulin and blood glucose.

2018: Are todays Continuous Glucose Monitoring precise and can they be used to reveal and reduce glycaemic variability?

Proposal number:

2018.004

Requested Studies

NN1218-3854

Lay summary

Use of devices for continuous monitoring of the blood sugar is valuable for people with diabetes to understand their disease and to help prevent low blood sugar. Furthermore, continuous monitoring should be used in drug development to evaluate efficacy and safety. However, the devices have been criticised for being too inaccurate. This investigation seeks to reveal the inaccuracies of current devices and to assess the subsequent usability related to the mentioned use cases

2018: Web Accessible Population Pharmacokinetics Service - Hemophilia (WAPPS-Hemo) Service

Proposal number:

2018.001

Requested Studies

NN7999-3747

NN7999-3639

Lay summary

Short lay summary of the proposed research
The service will be a centralized, dedicated, web-accessible, actively moderated tool that allows the input of anonymized and certified hemophilia patient PK data. The service will provide expert validation of the estimation of the PK disposition of factor VIII/IX and report the results to the inputting physician. The service will facilitate the progressive accumulation of PK patient data which will be continuously enhanced by the data inputted into the system; thereby, allowing for progressive refinement of the knowledge of factor VIII and IX pharmacokinetics. The service will lead to a reduction in the need for blood plasma samples in individual patients. This should result in better care, intended both as more effective prophylaxis and optimization of resource utilization.

2017: The psychosocial impact of diabetes and diabetes care provision for people with severe mental illness: a patient, carer and healthcare staff survey

Proposal number:

2017.005

Requested Studies

INS-3966 (DAWN2)

Lay summary

Short lay summary of the proposed research 
People with a severe mental illness (SMI), e.g. schizophrenia or bipolar disorder, are almost three times more likely to have diabetes, and experience poorer health and healthcare than the general population. Diabetes has a major psychosocial impact, causing distress, poor quality of life and reduced capacity for self-management. People with SMI have additional psychological and social difficulties that are likely to increase their risk of diabetes distress and poor quality of life. However, very little is known about the impact of diabetes in this population. 
This study will explore the psychological and social impact of having diabetes alongside SMI and experience of diabetes healthcare. The aim is to increase understanding of how to improve diabetes care, including diabetes self-management for this vulnerable population. We will survey people with SMI and diabetes, their carers and healthcare professionals to examine the psychosocial impact of diabetes in SMI including diabetes distress, quality of life, and factors affecting diabetes self-management. Participants will be recruited through general practices and mental health services. We will compare findings with data from DAWN2, a global study of diabetes in the general population (http://www.dawnstudy.com/dawn2/about-dawn2.html). We will also test whether questions to measure diabetes distress and psychosocial impact are appropriate for people with 
SMI. Multi-stakeholder workshops will be used to discuss findings and identify opportunities to increase support for diabetes management. 
This study will provide insights on how diabetes can be managed more effectively for people with SMI. Study findings will be disseminated through our established research, clinical and service user networks to increase knowledge among clinicians and service providers, who sometimes make assumptions about why people with SMI experience poor diabetes outcomes (e.g. attributing blame to lifestyle and life choices). People with SMI and diabetes should experience better care, and improved physical and mental health outcomes as a result. 

2017: Evaluation of clinical outcome in spontaneous intracerebral hemorrhage across age groups.

Proposal number:

2017.004

Requested Studies

F7ICH-1602

 

F7ICH-1371

 

F7ICH-2073

 

F7ICH-1389

 

F7ICH-1641

 

Lay summary

Short lay summary of the proposed research 
We know very little about how intracerebral hemorrhage affects the elderly. While what improves outcomes for younger people has been well documented little information exists concerning the elderly. We will describe this population looking for novel markers of improved outcome in elderly population. We hope this will lead to both improved manage of these elderly patients and novel therapeutic drug targets in intracerebral hemorrhage.

2016: Dipeptidyl-peptidase (DPP)-4 inhibitors or glucagon-like peptide (GLP)-1 analogues for prevention or delay of type 2 diabetes mellitus and its associated complications in persons at increased risk for the development of type 2 diabetes mellitus

Proposal number:

2016.001

Requested Studies

NN8022-1807, NN8022-3970, NN8022-1923, NN8022-1839

Lay summary

Short lay summary of the proposed research The incidence of type 2 diabetes is increasing worldwide. It is currently unknown if dipeptidyl-peptidase (DPP)-4 inhibitors or glucagon-like peptide (GLP)-1 analogues could prevent or delay type 2 diabetes mellitus and its associated complications in persons at increased risk for the development of type 2 diabetes mellitus. We will identify all published and unpublished trials including participants with increased risk of type 2 diabetes comparing DDP-4 inhibitors or GLP-1 analogues with no intervention, placebo or other glucose-lowering drugs with a duration of 12 weeks or more. Data and bias assessment will be performed by two authors. Data will be combined through meta-analysis. The outcomes assessed will be all-cause mortality; incidence of type 2 diabetes; serious adverse events, cardiovascular mortality; non-fatal myocardial infarction; congestive heart failure; non-fatal stroke; amputation of lower extremity; blindness or severe vision loss; end-stage renal disease; non-serious adverse events; hypoglycaemia; health-related quality of life; time to progression to type 2 diabetes; measures of blood glucose control; socioeconomic effects.

2017: Safety and effectiveness of long-acting versus intermediate-acting insulin for patients with type 1 diabetes: a systematic review and individual patient data network meta-analysis

Proposal number:

2017.001

Requested Studies

NN304-1335

NN304-1708

NN304-1595

NN304-1448

NN304-1205

NN304-1430

NN304-1687

NN304-1316

NN304-1372

NN304-1447

NN304-1181

NN304-1243

NN304-1375

Lay summary

Short lay summary of the proposed research

Type 1 Diabetes Mellitus (T1DM) is a basal-bolus insulin regimen, for which two choices exist for basal insulin: long- and intermediate-acting insulin. These choices may have different risks of adverse events and effectiveness. To help patients and clinicians optimally select a basal insulin, knowledge regarding how the effectiveness of these agents differs across patient characteristics (eg, lifestyle, age, general health) is required. We aim to investigate the association between the individualized treatments for T1DM patients and A1C or severe hypoglycaemia. The results will be of interest to stakeholders and will help in improving existing guideline recommendations.