Linagliptin reduced HbA1c in older patients with type 2 diabetes

Results from a phase 3 trial indicate that the DPP-IV inhibitor linagliptin significantly improved HbA1c among elderly patients with type 2 diabetes.

“Elderly individuals represent approximately 15% of people with type 2 diabetes worldwide,” Anthony H. Barnett, MD, FRCP, of the Heart of England NHS Foundation Trust and University of Birmingham, United Kingdom, said in a press release. “This study may help inform treatment decisions for improving glycemic control in the elderly.”

Anthony H. Barnett

Linagliptin (Tradjenta, Boehringer Ingelheim/Eli Lilly and Company) 5-mg tablets are currently available in the United States as a once-daily treatment for type 2 diabetes, besides diet and exercise.

Positive data

Barnett and colleagues randomly assigned 241 elderly patients (mean age, 74.9 years; mean HbA1c, 7.8%; mean fasting plasma glucose, 8.3 mmol/L) to linagliptin 5 mg (n=162) or placebo (n=79), besides their current diabetes medications (ie, metformin, sulfonylureas or basal insulin), in a double blind, parallel-group, multinational, phase 3 study for 24 weeks.

The researchers wrote that 238 patients completed the full analysis. According to data, patients randomly assigned linagliptin demonstrated a statistically significant placebo-adjusted mean change in HbA1c after 24 weeks (–0.64%; 95% CI, –0.81 to –0.48). Additionally, those assigned linagliptin had a placebo-adjusted mean decrease of FPG from baseline of –1.5 mmol/L (95% CI, –1.68 to –0.62).

There were no cases of pancreatitis reported, the drug was well tolerated among both treatment groups and no deaths occurred, researchers wrote. However, no statistically significant changes in bodyweight were observed among patients with available data, they added.

Frailty issues

In an accompanying commentary, Alan Sinclair, MD, FRCP, of the Institute of Diabetes for Older People at the University of Bedfordshire in the United Kingdom, and John Morley, MD, of the division of geriatric medicine and endocrinology at Saint Louis University School of Medicine in St. Louis, wrote that Barnett and colleagues provide evidence that linagliptin effectively lowered HbA1c.

Alan Sinclair

“This study, however, missed crucial opportunities to provide increased insight into the management of older patients with type 2 diabetes, and those who are frail in particular. Their description of HbA1c targets is vague and there is no mention of how these targets were discussed, managed, or achieved. Such practical issues are important and should not be neglected,” Sinclair and Morley wrote.

Moreover, the two wrote that Barnett and colleagues did not attempt to characterize their patients as frail and non-frail, thus failing to properly represent older patients with diabetes.

For more information:

Barnett AH. Lancet. 2013;doi:10.1016/S0140-6736(13)61500-7.

Sinclair A. Lancet. 2013;doi:10.1016/S0140-6736(13)61676-1.

Disclosure: Barnett reports honoraria for lectures and advisory work from Boehringer Ingelheim, Bristol-Myers Squibb/AstraZeneca, Eli Lily, MSD, Novartis, Novo Nordisk, Sanofi-Aventis and Takeda. Sinclair reports consultancy to Eli Lily, Janssen, MSD, Pfizer, Sanofi and Takeda. Morley reports consultancy fees from Nestle, Nutricia and Sanofi. All other researchers are employees of Boehringer Ingelheim.