Major study shows that, Tresiba (insulin degludec), compared to Lantus (insulin glargine), generates less overall episodes of hypoglycemia, and a bit more than half as many night-time episodes of hypoglycemia (the most dangerous). Significantly fewer patients on Tresiba experience severe hypoglycemia compared to Lantus. Trials were run for both Type 1 and Type 2 diabetes patients.
It occurs to me we never quoted the results of the SWITCH 1 & 2 trials on the forum! There were published on July 4, 2017 on JAMA. So here goes.
Novo Nordisk ran these trials between 2014 and 2016, in about 90 different locations, with a total of about 1,200 patients. The two trials were double-blind, randomized crossover trials:
- double-blind means that neither the patients nor the medical staff know who is taking what drug;
- randomized means that the patients are randomly assigned a trial group;
- crossover means that there are two phases, and that each batch of patients runs through both drugs, one in each phase.
These types of trials establish causality, and are pretty good at ruling out many sources of bias and error: they are the best type of trials you can run!
SWITCH 1 focused on patients with Type 1 diabetes. SWITCH 2 focused on patients with Type 2 diabetes. The results of both trials were similar. In both cases:
the overall rate of hypoglycemia was lower for Tresiba (2201/100PYE [Person year’s exposure] vs 2463/100PYE for Lantus in SWITCH 1, 186 vs 265 in SWITCH 2);
the night-time rate of hypoglycemia was significantly lower for Tresiba (277/100PYE vs 468/100PYE for Lantus in SWITCH 1, 55 vs 94 in SWITCH 20)
fewer patients on Tresiba experienced severe hypoglycemia (10% vs 17% on Lantus in SWITCH 1, 1.6% vs 2.4% in SWITCH 2).
The SWITCH 1 trial write-up in JAMA:
The SWITCH 2 trial write-up in JAMA: