Journal
DIABETES OBESITY & METABOLISM
Volume 23, Issue 2, Pages 642-647Publisher
WILEY
DOI: 10.1111/dom.14231
Keywords
glycaemic control; insulin therapy; linagliptin; phase III study; randomized trial; type 2 diabetes
Categories
Funding
- Boehringer Ingelheim
Ask authors/readers for more resources
The 24-week clinical trial in Chinese patients with T2DM showed that adding linagliptin to insulin therapy was more effective in improving glycemic control compared to placebo, with good tolerability and safety profile. There was no increased risk of hypoglycemia or weight gain observed, indicating that linagliptin could be a beneficial add-on therapy for these patients.
This 24-week, double-blind, placebo-controlled, phase III trial evaluated the efficacy and safety of linagliptin in 206 Chinese patients with inadequately controlled (glycated haemoglobin [HbA1c] 7.5%-10.0%) type 2 diabetes mellitus (T2DM) receiving insulin (basal or premixed) +/- metformin. Patients were randomized (1:1) to receive linagliptin 5 mg/d or placebo. The decrease from baseline in HbA1c (primary endpoint) was greater with linagliptin than with placebo (-0.61% vs. -0.20%, adjusted mean difference -0.40%; P = 0.0016). Linagliptin demonstrated significantly greater improvement in 2-hour postprandial glucose (-1.77 mmol/L [-31.95 mg/dL]; P < 0.001), and a numerical reduction in fasting plasma glucose (-0.34 mmol/L [-6.2 mg/dL]; P = 0.2241) versus placebo. Proportionally more patients on linagliptin achieved a HbA1c reduction of >= 0.5% versus those on placebo (odds ratio 2.293, P < 0.01). Adverse events in both groups were similar, with no new safety findings or clinically relevant changes in body weight. Among investigator-defined hypoglycaemic events (linagliptin: 17.3%; placebo: 12.7%; odds ratio 1.48, P = 0.337), none were severe. In Chinese patients with T2DM, linagliptin add-on to insulin improved glycaemic control and was well tolerated, without increased risk of hypoglycaemia or weight gain.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available