Linagliptin improves glycemic control after 1 year as add-on therapy to basal insulin in Asian patients with type 2 diabetes mellitus

Abstract

Objective:

To evaluate the efficacy and long-term safety of linagliptin added to basal insulin in Asian patients with type 2 diabetes mellitus (T2DM) inadequately controlled by basal insulin with/without oral agents.

Research design and methods:

This was a post hoc analysis of Asian patients from a global ≥52 week study in which patients on basal insulin were randomized (1:1) to double-blind treatment with linagliptin 5 mg once daily or placebo (NCT00954447). Basal insulin dose remained stable for 24 weeks, after which adjustments could be made according to the investigator’s discretion to improve glycemic control. The primary endpoint was the mean change in glycated hemoglobin (HbA1c) from baseline to 24 weeks.

Results:

Data were available for 154 Asian patients (80 linagliptin, 74 placebo). Baseline HbA1c (standard deviation [SD]) was 8.6 (0.9)% (70 [10] mmol/mol). The placebo-corrected mean change (standard error [SE]) in HbA1c from baseline was −0.9 (0.1)% (−10 [1] mmol/mol) (95% confidence interval [CI]: −1.2, −0.7; p < 0.0001) at Week 24 and −0.9 (0.1)% (−10 [1] mmol/mol) (95% CI: −1.1, −0.6; p < 0.0001) at Week 52. The frequency of adverse events (linagliptin 81.3%, placebo 91.9%) and hypoglycemia (Week 24: linagliptin 25.0%, placebo 25.7%; treatment end: linagliptin 28.8%, placebo 35.1%) was similar between groups. By Week 52, changes (SE) in mean body weight were similar in both groups (linagliptin −0.67 [0.26] kg, placebo −0.38 [0.25] kg).

Conclusions:

This study was limited by the post hoc nature of the analysis and the small number of patients in the subgroup. However, the results suggest that linagliptin significantly improves glycemic control in Asian patients with T2DM inadequately controlled by basal insulin, without increasing the risk for hypoglycemia or weight gain.

ClinicalTrials identifier:

NCT00954447.

Keywords: :

• Asian patients
• Basal insulin
• Linagliptin
• Type 2 diabetes mellitus

Transparency

Declaration of funding

This work was funded by Boehringer Ingelheim.

The authors were fully responsible for all content and editorial decisions, were involved at all stages of manuscript development, and have approved the final version.

Declaration of financial/other relationships

W.H.-H.S. and S.W.P. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. Y.G., S.Pi., S.Pa., T.S., and H.-J.W. have disclosed that they are employees of Boehringer Ingelheim. S.B. has disclosed that he was an employee of Boehringer Ingelheim at the time of this study and is now an employee of AstraZeneca.

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

Acknowledgments

Medical writing assistance, supported financially by Boehringer Ingelheim, was provided by Claire Stevens of Envision Scientific Solutions during the preparation of this manuscript.

Previous presentations: The abstract of this paper was published along with an oral presentation at the IDF-WPR 2012.