Hannel Yki-Järvinen, MD, from the Department of Medicine at the University of Helsinki and Minerva Foundation Institute for Medical Research in Finland, and colleagues set out to test the efficacy of linagliptin on 1,261 patients taking basal insulin.
Basal insulin is a long-lasting insulin that helps control blood sugar between meals and during sleep.
Linagliptin (brand name Tradjenta) is a DPP-4 inhibitor. DPP-4 is dipeptidyl peptidase IV, an enzyme that turns off hormones in the gut called incretins. These hormones stimulate beta cells in the pancreas causing them to secrete more insulin. By inhibiting DPP-4, incretins are able to do their job, helping the body generate more insulin.
Coming from 167 medical centers in 19 countries, the patients in this study were either taking basal insulin alone or in combination with metformin (brand names Glucophage, Glucophage XR and Glumetza) and/or pioglitazone (brand name Actos) — oral medications that further help control blood sugar levels. All participants, however, still had inadequate blood sugar control.
Individuals were randomly assigned to receive either five milligrams of linagliptin daily (631 patients) or a placebo (630 patients) for at least 52 weeks.
The linagliptin group had better results in reducing HbA1c compared to the placebo group.
An HbA1c of less than 7 percent is a common treatment goal for many diabetes patients. Among those patients in this study who had an A1C of 7 percent or more, 16 percent of the linagliptin group reached the less than 7 percent goal after 52 weeks, while 7 percent of the placebo group reached that goal.
The authors observed that adding linagliptin to the insulin treatment did not increase hypoglycemia (abnormally low blood sugar level) or weight gain.
The authors also noted there was no need to alter dose of linagliptin in the elderly or in those with impaired renal (kidney) function.
Diabetes Care. Sept, 2013