Fotagliptin Plus Metformin Enhances Glycemic Control in T2D

TOPLINE:

Addition of fotagliptin to metformin significantly reduced A1c levels in patients with type 2 diabetes (T2D) compared with placebo plus metformin without increasing the incidence of hypoglycemic events.

METHODOLOGY:

• Previous research indicated that fotagliptin, a dipeptidyl peptidase 4 inhibitor, provided superior glycemic control than placebo in patients with T2D.
• Researchers conducted a randomized controlled trial across 53 outpatient clinics in China to evaluate the efficacy and safety of fotagliptin as an add-on to metformin in patients with T2D.
• They included 402 patients with T2D (mean age, 55.1 years; mean A1c level, 8.09%; 59% men) who underwent dietary and exercise interventions and received a stable dose of ≥ 1500 mg/d metformin for at least 8 weeks before screening.
• Patients were randomly assigned in a 2:1 ratio to receive either fotagliptin 12 mg once daily or placebo in addition to a stable dose of metformin for 24 weeks during the double-blind treatment. Afterward, all patients received fotagliptin 12 mg once daily as part of the open-label fotagliptin treatment until the end of 52 weeks.
• The primary endpoint was a change in the A1c level from baseline to week 24.

TAKEAWAY:

• At week 24, patients on metformin plus fotagliptin had least square mean change in the A1c level of -0.81% compared with -0.28% in those on metformin plus placebo, with an estimated treatment difference of -0.53% (P < .001).
• The A1c target of < 7.0% was achieved by 38.7% of patients on metformin plus fotagliptin compared with 16.9% of patients on metformin plus placebo (P < .0001), with similar results observed for the A1c target of ≤ 6.5% (P < .0001).
• In either group, the incidence of treatment-emergent adverse events leading to drug discontinuation was low.
• Hypoglycemic events were relatively less frequent in both groups and were considered mild to moderate.

IN PRACTICE:

“In patients with T2D, who were treated with metformin, add-on with fotagliptin 12 mg once daily achieved a superior and clinically meaningful decrease in HbA1c compared with placebo,” the authors concluded.

SOURCE:

This study was led by Nan Yu, MD, Peking University First Hospital, Beijing, China. It was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

This study included only Chinese patients with T2D, which may suggest selective bias. The duration of this study was not long enough to assess cardiovascular outcomes or benefits.

DISCLOSURES:

This study was supported by Shenzhen Salubris Pharmaceuticals Co., Ltd, with partial funding from the Shenzhen Science and Technology Program for Undertaking the National Science and Technology Major Project. One author reported being an employee of Shenzhen Salubris Pharmaceuticals Co., Ltd.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.