Patient reported outcomes in adults with type 2 diabetes on basal insulin randomized to addition of mealtime pramlintide or rapid-acting insulin analogs

Abstract

Objective:

To determine whether treatment satisfaction and quality of life were affected by adding mealtime pramlintide or rapid-acting insulin analogs (RAIAs) to basal insulin therapy for patients with inadequately controlled type 2 diabetes.

Research design and methods:

In this 24-week open-label, multicenter study of adults with type 2 diabetes, mealtime pramlintide (PRAM) (120 μg fixed dose; n = 56) or titrated RAIAs (n = 56) was added to basal insulin therapy with or without oral antidiabetic medications.

Clinical trial registration:

ClinicalTrials.Gov NCT00467649

Main outcome measures:

Quality of life (Diabetes Distress Scale – DDS, and Pittsburgh Sleep Quality Index – PSQI), and treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire – DTSQ, and Pramlintide Treatment Satisfaction Questionnaire – PRAM-TSQ) were assessed at baseline and week 24. Mixed-effect models estimated mean group changes from baseline to week 24 (adjusted for baseline scores) in patient reported outcomes.

Results:

PRAM patients experienced significant improvement in total diabetes distress, while RAIA patients did not; both groups experienced significant improvement in regimen-related distress and physician-related distress. Between-group differences in DDS measures were not significant. PRAM patients experienced significant improvement in sleep latency and daytime dysfunction, while RAIA patients did not; the difference between groups was significant for daytime dysfunction. Both treatment groups experienced significant improvement in most individual DTSQ items and total diabetes treatment satisfaction, while only PRAM patients experienced significant improvement in perceived hypoglycemia. Between-group differences in DTSQ measures were not significant. Both treatment groups experienced significant improvement in most individual PRAM-TSQ items and total treatment satisfaction; RAIA patients experienced increased eating flexibility and reduced perceived weight control. PRAM patients experienced significantly better perceived weight and appetite control than RAIA patients.

Limitations:

The sample size was relatively small and there were few non-white subjects. The schedule for implementation of change in therapy may have affected study outcomes.

Conclusions:

Adding pramlintide on a background of basal insulin improved some aspects of treatment satisfaction and quality of life relative to adding rapid-acting insulin analogs.

Key words::

• Pramlintide
• Insulin
• Quality of life
• Treatment satisfaction
• Randomized controlled trial

Transparency

Declaration of funding

This study was funded by Amylin Pharmaceuticals Inc., San Diego, CA, USA. M.P., R.R.R and W.H.P. have received research and consultation funding from Amylin. J.H.B. is an Amylin employee.

Declaration of financial/other relationships

M.P has received research and consultation funding from Animas, Eli Lilly, MannKind, Medtronic MiniMed, Novo Nordisk, and Patton Medical Devices. R.R.R has received research and consultation funding from Animas, Eli Lilly, Lifescan, MannKind, Medingo, Medtronic MiniMed, Novo Nordisk, Patton Medical Devices, and sanofi-aventis. W.H.P. has received funding from Abbott, Eli Lilly, Novo Nordisk, Roche, and sanofi-aventis.

Peer reviewers may receive honoraria from CMRO for their review work. Peer Reviewers 1 and 2 have disclosed that they have no relevant financial relationships.

Acknowledgments

No medical writers were involved in the preparation of this manuscript.

Previous presentation: Data was presented at the 69th Scientific Session of the American Diabetic Association25.