Clinical outcomes after 24 months of insulin therapy in patients with type 2 diabetes in five countries: results from the TREAT study

Abstract

Objective:

To assess factors associated with insulin regimens at initiation, changes in treatment and metabolic control over 2 years of insulin therapy in patients with type 2 diabetes in five countries.

Research design and methods:

TREAT was a prospective, 24 month, observational study in patients with type 2 diabetes initiating insulin in clinical practice. Patient characteristics were collected at baseline and metabolic outcomes at 3, 6, 12, 18 and 24 months after initiation.

Results:

A total of 985 patients were enrolled, 886 assessed at baseline and 734 (82.8%) at 24 months. Baseline characteristics varied between countries: 52.8% of patients were men; mean age was 60.4 years; body mass index, 29.7 kg/m²; time since diagnosis, 10.1 years; HbA_1c, 9.6%. Less than 25% of patients met ADA/IDF targets for blood pressure/LDL cholesterol. Overall, 50.1% of patients were initiated on long/intermediate insulin, 39.3% on mixture and 7.8% on basal–bolus; distribution varied between countries. Patients on long/intermediate were more likely to have lower baseline HbA_1c and be intensified to other regimens (19.4%). No oral antidiabetic medication was used for 16.4% initiating on long/intermediate, 47.4% on mixture and 62.3% with basal–bolus. Overall, mean HbA_1c decreased from 9.6% to 7.6%, with little difference between regimens at endpoint. The percentage of patients with hypoglycaemia was highest at 6 months and with basal–bolus.

Limitations:

Sites were not selected at random. Drop-out of patients prior to 24 months may have introduced a bias that favoured responders.

Conclusions:

Mean baseline HbA_1c was high, indicating delayed initiation of insulin treatment. Blood pressure and lipids were suboptimally controlled. Insulin regimens varied between countries, changed little and resulted in similar HbA_1c levels after 24 months.

Keywords::

• Insulin treatment
• Observational study
• Type 2 diabetes

Transparency

Declaration of funding

This study and the development of this manuscript were supported by Eli Lilly and Company.

Declaration of financial/other relationships

A.O., M.B., K.B. and C.M. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. P.M. has served as a chairperson/speaker for events promoted by Eli Lilly and Company. S.P.C. and H.S. are employees of and own stocks in Eli Lilly and Company. J.G. is a medical writer whose writing assistance was supported by 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 thank Jürgen Deinhard of Accovion GmbH for his statistical assistance. Support for statistical assistance was provided by Eli Lilly and Company.

Previous presentation: Marianna Benroubi, Henry Schmitt, Simon P Cleall, Kyriakos Aloumanis, Lauren J Lee for the TREAT Study Investigators. Costs and Clinical Outcomes After 24 Months of Insulin Therapy in Patients With Type 2 Diabetes: Results From the TREAT Study. 47th European Association for the Study of Diabetes (EASD) Annual Meeting, Lisbon, Portugal, 12–16 September 2011.