Clinical outcomes after insulin initiation in patients with type 2 diabetes: 6-month data from the INSTIGATE observational study in five European countries

Abstract

Objectives:

To examine insulin regimens and factors that affect glycaemic control at 6 months after initiation of insulin therapy in patients with type 2 diabetes mellitus.

Research design and methods:

Information on patients requiring insulin initiation as part of usual care was collected in a prospective, observational, open-label study in five European countries. Univariate and multiple regression analyses were used to investigate factors associated with HbA1c achieved at 6 months.

Results:

Mean HbA1c for all patients at baseline was 9.6 ± 1.8%. Long/intermediate-acting insulin only was most commonly initiated in France and Spain, while long/intermediate or pre-mixed formulations were initiated in Greece and UK. This was consistent with guidelines used in those countries and there was little change in insulin regimen at 6 months in these countries. In Germany, short-acting insulin only was favoured at baseline and there was a shift towards basal/bolus regimens at 6 months, which reflected the local guidelines for insulin initiation in Germany. Mean HbA1c reduction was greatest in Germany (−2.3%), which was the only country to achieve a mean of <7% at 6 months. In all countries, HbA1c achieved at 6 months was associated with baseline HbA1c. Differences between countries were seen for influence of factors such as BMI, duration of diabetes, insulin regimen, insulin dose and number of oral anti-diabetes drugs on HbA1c achieved. Explained variability for the factors ranged from 5.6% to 22.9%.

Conclusions:

Differences in insulin regimen were observed between countries, and appeared to reflect the guidelines and treatment regimens used.

Key words::

• glycaemic control
• HbA1c
• insulin therapy
• type 2 diabetes

Transparency

Declaration of funding

The INSTIGATE study was funded by Eli Lilly and Company.

Declaration of financial/other relationships

A.L., S.J., M.B., C.C., A.G. and M.A.C. have received lecture fees and advisory board honoraria from Eli Lilly and Company, as well as from other pharmaceutical companies developing products for treatment of patients with type 2 diabetes. H.T.S., C.N. and A.S. are employees of Eli Lilly and Company.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgements

The authors are very grateful to the investigators involved in the INSTIGATE clinical trial for providing data for this study. The authors would also like to thank Dr Peter C. Bates, Cambridge Medical Writing Services, UK for help in preparation and editing of the manuscript, which was funded by Eli Lilly and Company. The INSTIGATE study was funded by Eli Lilly and Company.