Approved data access requests

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.

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 We will identify all published and unpublished trials including participants with increased risk of type 2 diabetes comparing DDP-4 inhibitors or GLP-1 analogues with no intervention, placebo or other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.

2015: Individual patient data meta-analysis of randomised controlled trials comparing glycaemic control during continuous subcutaneous insulin infusion vs. multiple daily insulin injections in type 2 diabetes mellitus

Proposal number:

2015.001

Requested Studies

ANA-2023

Lay summary

Insulin pump therapy has proved to be useful in improving diabetes control in selected people with type 1 diabetes but there has been conflicting evidence to date for its effectiveness in type 2 diabetes. In order to identify if there are patient groups that benefit more than others from insulin pump treatment in type 2 diabetes, we now wish to combine the data from all published randomised controlled trials on changes in control during pump therapy compared to best injection therapy (a ‘meta-analysis’). Using advanced statistical techniques, we will analyse the effect of individual patient characteristics such as level of diabetes control at the start of the study (HbA1c), weight and insulin dosage on the effect of pump therapy on HbA1c, hypoglycaemia, insulin dose and weight change.

Publications

Diabetes Care. 2017 May;40(5):715-722. doi: 10.2337/dc16-2201. Glycemic Control During Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Insulin Injections in Type 2 Diabetes: Individual Patient Data Meta-analysis and Meta-regression of Randomized Controlled Trials. Pickup JC, Reznik Y, Sutton AJ

2015: Web Accessible Population Pharmacokinetics Service – Hemophilia (WAPPS-Hemo) Service

Proposal number:

2015.002

Requested Studies

NN7008-3893 NN7008-3522

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 haemophilia 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.

2014: Determination of HbA1c variability of 2 insulins, degludec and glargine, in the BEGIN once long trial

Proposal number:

2014.001

Requested Studies

NN1250-3579

Lay summary

The HbA1c test is a measure of diabetes glucose control over a 2 month period and may vary month by month depending on overall glucose control. We have shown for patients with type 1 diabetes that over the months those patients whose HbA1c remains steady have fewer diabetes related problems than those whose HbA1c varies. By looking at the data from the BEGIN once long study over a 12 month period, we can see if the HbA1c variability for one type of insulin (degludec) is less than for another (glargine) in type 2 diabetes. This may provide information on which to base a long term study in the future.