Pharmacokinetic and dose-finding studies on efpeglenatide in patients with type 2 diabetes.

ABSTRACT:

Aim

To assess the efficacy, safety and pharmacokinetic/pharmacodynamic properties of efpeglenatide, a long-acting glucagon-like peptide-1 receptor agonist, in patients with type 2 diabetes (T2D).

Research design and methods

Two randomized, double-blind, placebo-controlled phase 2 trials were conducted. The single-dose study (n = 48) was a first-in-patient, sequential dose-escalation study. Patients received a single subcutaneous injection of efpeglenatide (2-100 μg/kg) or placebo. The repeated-dose study (n = 71) was a multiple-ascending-dose trial. Patients received weekly (1, 2 or 4 mg once weekly; 8-week period) or monthly (8, 12 or 16 mg once monthly; 9-week period) subcutaneous injections of efpeglenatide or placebo (without titration).

Results

Both studies demon

SUBMITTER: Yoon KH 

PROVIDER: S-EPMC7383501 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature