Trulicity helps SGLT-2 patients lower blood sugar

New phase 3b trial results show Lilly’s Trulicity has helped type 2 diabetes patients already taking an SGLT2 inhibitor but whose blood sugar was inadequately controlled.

The AWARD trial showed that adding the injection helped these patients lower their HbA1C compared to those taking an SGLT2 inhibitor and placebo, reinforcing Trulicty as an option for these patients.

The trial conducted over 24 weeks, found that adding Trulicity to a existing SGLT2 treatment produced -1.34%, -1.21% for Trulicity 1.5 mg and 0.75 mg, respectively.

This compared to an SGLT-2 inhibitor with placebo of -0.54%.

It also showed that significantly more people in the Trulicity groups reached target A1C levels of less than 7% and less than or equal to 6.5%.

However the trial didn’t demonstrate any extra ‘synergistic’ benefits in combining the drugs, which other GLP-1 plus SGLT2 inhibitor trials have shown.

A trial of AstraZeneca’s GLP-1 Bydureon combined its SGLT2 inhibitor Forxiga in the DURATION-8  suggested a synergistic effect of the drugs when initiated together.

The trial didn’t include an arm comparing the combination to Trulicity alone, but if it had, it looks likely that the two drugs together wouldn’t have outperformed the GLP-1 as a monotherapy.

Trials of Trulicity alone show it produces a 1.4 reduction from a mean baseline HbA1C of 8.1%.  However it remains difficult to persuade patients to move to injectable GLP-1 therapies despite their greater efficacy, and are often only prescribed them when oral therapies fail to control blood glucose.

Novo Nordisk gaining ground

The AWARD trial will help provide Trulicity’s value to these patients, but won’t help much in its Lilly’s battle with arch-rivals Novo Nordisk.

Lilly is  Victoza is the market’s leading GLP-1 analogue, and both companies are looking to demonstrate superior results with their next innovation.

Novo Nordisk has had a run of good news, launching its next-generation GLP-1 Ozempic recently, and last week unveiling promising data for an oral version of the drug.

Lilly has had an advantage over Novo until recently, as Trulicity matched Victoza’s blood sugar lowering, but needs to be taken just once a week, rather than daily.

But Ozempic (semaglutide) is a weekly injection, and has also demonstrated superior efficacy to Trulicity in head-to-head trials.

The Novo Nordisk drug was compared to Trulicity in its SUSTAIN 7 trial in low and high doses.

Ozempic cut the HbA1C of patients by 1.5% compared with 1.1% by Trulicity at the low dose, and 1.8% compared with 1.4% at the high dose, with more patients hitting their target.

Last week’s PIONEER 1 trial showed an oral semaglutide matched the performance of its injectable formulation at its highest dose. This is very good news for Novo, which is now enrolling patients for further phase 3a trials of the drug. Once approved, this oral version could open up a much bigger diabetes market, as the need to inject GLP-1 drugs still deters many patients.

Please note this article was updated to correct errors relating to the description of the AWARD trial.

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.