Changes in HbA_1c, insulin dose and incidence of hypoglycemia in patients with type 1 diabetes after switching to insulin degludec in an outpatient setting: an observational study

Abstract

Objective:

Insulin degludec, a basal insulin with an ultra-long duration of action, became available in Sweden from July 2013. The diabetes team at Danderyd Hospital decided to perform a clinical follow-up of patients with type 1 diabetes switching to insulin degludec to evaluate its clinical performance, using a simple form and available measures, thereby indirectly assessing cost-effectiveness.

Research design and methods:

This was a prospective, open-label, single-arm, observational, clinical follow-up from August 2013 to February 2015 of consecutive patients who switched to insulin degludec according to predefined indications (i.e., currently administering basal insulin twice daily, unacceptable HbA_1c, repeated hypoglycemic events and/or unstable glucose, difficulty with fixed-time administration) in conjunction with professional judgment and patient wishes. Information about HbA_1c, insulin dose and frequency of hypoglycemia (self-reported by patient recall) was collected at baseline and repeated after 4–6 months.

Results:

In February 2015, data were available on 357 patients. Median time to follow-up was 20 weeks. Mean (SD) HbA_1c decreased from 68.9 (15.7) to 65.8 (14.3) mmol/mol, p < 0.0001, and this improvement was achieved despite less insulin. Median reduction of the total insulin dose (basal + prandial) was 12% (interquartile range [IQR] −20% to −3%). The mean (SD) number of self-reported hypoglycemic events in the previous 4 weeks decreased from 8.2 (8.9) to 6.4 (7.6) events, p < 0.0001, and nocturnal hypoglycemic events were reduced from 1.6 (2.9) to 0.7 (2.0) events, p < 0.0001.

Conclusion:

Due to improvement in glycemic control, reduction of hypoglycemic events and reduction of insulin dose, we concluded that insulin degludec was clinically useful and economically justifiable for our patients with type 1 diabetes. Not every patient may benefit to the same degree after switching to insulin degludec. Controlled studies are needed to confirm these benefits in a larger sample of real-world patients.

Keywords: :

• Basal–bolus
• Basal insulin
• HbA_1c
• Hypoglycemia
• Insulin degludec
• Outpatient
• Type 1 diabetes

Transparency

Declaration of funding

This clinical follow-up was conducted by the diabetes team at Danderyd Hospital, with no external funding. Medical writing and editorial assistance, as described below, was sponsored by Novo Nordisk. Novo Nordisk had no role in the collection, analysis, interpretation or reporting of these data.

Declaration of financial/other relationships

L.L.-H. has disclosed that she has served on advisory boards and consulted for Novo Nordisk, received research support from Sanofi and has also received honoraria for giving lectures for Novo Nordisk, Sanofi, Lilly, Abbott, Bayer and Boehringer-Ingelheim.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The author thanks all the members of the Danderyd Diabetes Clinic (DDC) diabetes team for collecting data. Statistical support was provided by Fredrik Johansson, Department of Clinical Sciences, Karolinska Institutet at Danderyd Hospital. Writing and editorial support for this manuscript was provided by Gary Patronek and Daria Renshaw of Watermeadow Medical.