Real-World Effectiveness of Insulin Glargine 300 Initiation in Switzerland

Abstract

Introduction

Insulin glargine 300 U/mL (Gla-300; Toujeo^®) is a second-generation once-daily basal insulin. Previous randomized controlled trials showed comparable HbA1c reductions with lower rates of hypoglycemia of Gla-300 versus Gla-100.

Patients and Methods

We report the 12 months results of the Swiss cohort of Toujeo-1, a prospective, observational multicenter study exploring the real-world effectiveness of Gla-300 in adult patients with type 2 diabetes (T2D) uncontrolled (HbA1c 7.5–10%) on oral therapy and compared these to the overall Toujeo-1 cohort (conducted in Switzerland and Germany). Primary endpoint was the percentage of patients achieving individual HbA1c targets. Secondary endpoints included changes in HbA1c, fasting plasma glucose (FPG), body weight, insulin dose, incidence of hypoglycemia and overall safety.

Results

The analysis included 47 patients (14 women) with a mean age of 64.1 years and a diabetes duration of 8.4 years. Swiss physicians determined a higher HbA1c treatment target (7.4 vs. 7.0%) and patients received higher Gla-300 doses at baseline (20.2 vs. 14.7 units/day) and the 12-month follow-up (31.0 vs. 26.2 units/kg) than in the total cohort (n=721). After 12 months, the addition of Gla-300 reduced HbA1c by 1.5% (p<0.0001) to an HbA1c of 7.2%, and FPG by 3.3 mmol/L (p<0.0001) to an FPG of 7.1 mmol/L. At 12 months, 70.2% achieved their individual HbA1c target, more than in the overall Toujeo-1 cohort (49.9%). Body weight remained stable throughout. Only episodes of symptomatic, non-severe hypoglycemic events were documented (2.1%) with similar rates as for the overall Toujeo-1 population.

Conclusion

In patients with T2D on oral therapy and newly treated with basal insulin, Gla-300 improves glycemic control with a low risk of hypoglycemia and no increase of body weight. The results for Switzerland are consistent with those reported for the overall Toujeo-1 cohort and reveal that treatment targets and approaches slightly differ between both countries.

Keywords:

• insulin glargine 300 U/mL
• type 2 diabetes
• real-world
• Switzerland

Compliance with Ethics Guidelines

This study was approved by the Commission cantonale d`éthique de la recherché sur l`être (CER-VD; protocol number 464/15). This study conformed with the Helsinki Declaration of 1964, as revised in 2013, concerning human rights. All study participants provided informed consent.

Editorial Assistance

Editorial assistance in the preparation of this article was provided by Sanofi-aventis (suisse) sa.

Acknowledgments

The authors wish to thank the study participants for their involvement in the study.

In memory of Dr. Nicola Alexander-David, who was an investigator in this study and died during the preparation of the manuscript.

Author Contributions

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article. All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting,  revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

François R Jornayvaz has received honoraria for consultancy from Sanofi, Eli Lilly, Boehringer Ingelheim and Novo Nordisk. The authors report no other conflicts of interest in this work.

Additional information

Funding

Sanofi-aventis (suisse) sa is the sponsor of this study.