Observational, open-label study of type 1 and type 2 diabetes patients switching from human insulin to insulin analogue basal–bolus regimens: insights from the PREDICTIVE study

Abstract

Objective:

Evaluation of the safety and efficacy of insulin detemir (IDet) in the observational and non-interventional PREDICTIVE study.

Methods:

A total of 2923 patients with type 1 or 2 diabetes on basal–bolus regimens were followed for 6 months: Group (1) NPH + human insulin (HI) bolus switching to IDet + analogue bolus (n = 349); Group (2) NPH + HI bolus switching to IDet + HI bolus (n = 500); Group (3) NPH + analogue bolus switching to IDet + analogue bolus (n = 1144); Group (4) Glargine + analogue bolus switching to IDet + analogue bolus (n = 704). Primary endpoint was major hypoglycaemia; change in HbA_1c, fasting plasma glucose, fasting plasma glucose variability and bodyweight were secondary endpoints.

Results:

These results need critical review due to the observational nature of the study (non-randomisation, no control group) as well as limitations of a possible study effect and the fact that some endpoints are based on patient recall, diaries or reports. Mean incidence of any hypoglycaemia was significantly reduced following the switch to insulin detemir therapy in all groups: the greatest reduction in total hypoglycaemia was in Group 1 from 42.38 to 20.28 episodes per patient-year (mean difference −22.10; p < 0.0001) and in nocturnal hypoglycaemia from 11.83 to 2.08 episodes/patient-year (mean difference −9.88; p < 0.0001). HbA_1c, FPG and FPG variability also improved significantly in all groups: the greatest reduction in HbA_1c was in Group 1 from 8.13 to 7.42% (mean difference −0.71; p < 0.0001). Bodyweight was reduced in all groups.

Conclusions:

Whichever basal–bolus insulins were previously used, switching to insulin detemir as the basal insulin component resulted in significant lowering of hypoglycaemia, HbA_1c, FPG and bodyweight over a period of 6 months in patients with type 1 or 2 diabetes. Switching to an all-analogue regimen may be the most effective option when moving patients from human insulin-based basal–bolus regimens.

Key words: :

• Diabetes
• Glycaemic control
• Hypoglycaemia
• Insulin aspart
• Insulin detemir
• Observational study

Transparency

Declaration of funding

The PREDICTIVE study and the publication of this article are sponsored by Novo Nordisk A/S, Copenhagen, Denmark.

Declaration of financial/other arrangements

All contributing authors have received support from Novo Nordisk A/S, Copenhagen, Denmark.

Peer Reviewer 1 has disclosed that he/she is a recipient of research/grant funding from, is a consultant/advisor to, and is a member of the speaker's bureaux for: Pfizer, Merck & Co. Inc., Schering-Plough, Servier, Hoffman-La-Roche, Eli-Lilly, Novo Nordisk, Daiichi Sankyo, Takeda, GlaxoSmithKline, Sanofi-Aventis and Novartis. Peer Reviewer 2 has disclosed that he/she is the recipient of research/grant funding from GlaxoSmithKline, Novartis, Novo-Nordisk, Takeda, Astra-Zeneca, Pfizer, Sanofi-Aventis, Eli Lilly and Daiichi-Sankyo; is a consultant to, and lecturer for GlaxoSmithKline, Novartis, Takeda, Pfizer, Sanofi-Aventis, Eli Lilly and Daiichi Sankyo.

Acknowledgements

Editorial assistance in the preparation of this manuscript was provided by Elizabeth Southey and Sheila Dunleavy of Watermeadow Medical. This assistance was funded by Novo Nordisk A/S.