Efficacy and safety of an albiglutide liquid formulation compared with the lyophilized formulation: A 26-week randomized, double-blind, repeat-dose study in patients with type 2 diabetes mellitus.

Abstract

AIMS:

Compare the efficacy and safety of albiglutide from a ready-to-use, single-dose, auto-injector system with the lyophilized product in patients with type 2 diabetes mellitus (T2DM).

METHODS:

In this phase 3 study, 308 patients between 18 and 80 years with T2DM and experiencing inadequate glycemic control on their current regimen of diet/exercise alone or in combination with metformin were randomized 1:1 to weekly injections for 26 weeks with an active albiglutide auto-injector and placebo lyophilized dual-chamber cartridge (DCC) pen injector (n = 154) or active albiglutide lyophilized DCC pen injector and placebo liquid auto-injector (n = 154). Participants received liquid or lyophilized albiglutide 30 mg for 4 weeks, and then 50 mg for the remaining 22 weeks. Change in HbA1c and fasting plasma glucose (FPG), pharmacokinetics, and safety were assessed.

RESULTS:

In the albiglutide liquid and lyophilized drug product groups, 55.6% (85/153) and 45.5% of patients (70/154) had a baseline HbA1c ≥ 8.0%, respectively. The model-adjusted least squares (LS) mean change in HbA1c from baseline at week 26 was -1.1% (95% CI: -1.3, -1.0) and -1.2% (95% CI: -1.3, -1.0; noninferiority P = 0.0002) in the albiglutide liquid and lyophilized product groups, respectively. Similarly, the model-adjusted LS mean change in FPG from baseline at week 26 in the albiglutide liquid and lyophilized product groups was -2.2 (95% CI: -2.6, -1.8) mmol/L and -1.9 (95% CI: -2.3, -1.5) mmol/L, respectively. No new safety concerns were identified.

CONCLUSION:

Change from baseline in HbA1c for albiglutide liquid was noninferior to lyophilized drug product in patients with T2DM.

• Authors: Bonnie C Shaddinger, Joseph Soffer, Georgios Vlasakakis, Mayadah Shabbout, Cindy Weston, Antonio Nino
• Journal: Diabetes research and clinical practice (Diabetes Res Clin Pract) Vol. 152 Pg. 125-134 (Jun 2019) ISSN: 1872-8227 [Electronic] Ireland
• PMID: 31004676 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2019 Elsevier B.V. All rights reserved.

Chemical References

• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Solutions
• rGLP-1 protein
• Glucagon-Like Peptide 1
• Metformin

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Blood Glucose (drug effects, metabolism)
• Diabetes Mellitus, Type 2 (blood, drug therapy)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Drug Compounding
• Female
• Freeze Drying
• Glucagon-Like Peptide 1 (administration & dosage, adverse effects, analogs & derivatives)
• Glycated Hemoglobin (analysis, drug effects, metabolism)
• Humans
• Hypoglycemic Agents (administration & dosage, adverse effects)
• Male
• Metformin (administration & dosage, adverse effects)
• Middle Aged
• Solutions
• Treatment Outcome
• Young Adult