Efficacy and safety of Tregopil, a novel, ultra-rapid acting oral prandial insulin analog, as part of a basal-bolus regimen in type 2 diabetes: a randomized, active-controlled phase 2/3 study.


Journal

Expert opinion on pharmacotherapy
ISSN: 1744-7666
Titre abrégé: Expert Opin Pharmacother
Pays: England
ID NLM: 100897346

Informations de publication

Date de publication:
Nov 2022
Historique:
pubmed: 11 11 2022
medline: 22 11 2022
entrez: 10 11 2022
Statut: ppublish

Résumé

Efficacy and safety of ultra-rapid acting oral prandial insulin Tregopil was compared with insulin aspart (IAsp) in patients with type 2 diabetes (T2D) on insulin glargine and metformin. In this open-label, active-controlled trial, patients with T2D, HbA The observed mean HbA Tregopil demonstrated an ultrafast, short-duration prandial profile with good safety. While Tregopil's early postprandial effects were comparable to IAsp, its late postprandial effects were inferior. The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT03430856).

Sections du résumé

BACKGROUND UNASSIGNED
Efficacy and safety of ultra-rapid acting oral prandial insulin Tregopil was compared with insulin aspart (IAsp) in patients with type 2 diabetes (T2D) on insulin glargine and metformin.
RESEARCH DESIGN AND METHODS UNASSIGNED
In this open-label, active-controlled trial, patients with T2D, HbA
RESULTS UNASSIGNED
The observed mean HbA
CONCLUSIONS UNASSIGNED
Tregopil demonstrated an ultrafast, short-duration prandial profile with good safety. While Tregopil's early postprandial effects were comparable to IAsp, its late postprandial effects were inferior.
TRIAL REGISTRATION UNASSIGNED
The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT03430856).

Identifiants

pubmed: 36352762
doi: 10.1080/14656566.2022.2141569
doi:

Substances chimiques

Insulin 0
Insulin Aspart D933668QVX
Insulin Glargine 2ZM8CX04RZ

Banques de données

ClinicalTrials.gov
['NCT03430856']

Types de publication

Randomized Controlled Trial Clinical Trial, Phase II Clinical Trial, Phase III Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1855-1863

Auteurs

Harold E Lebovitz (HE)

Department of Medicine, State University of New York Health Science Center at Brooklyn, Brooklyn, NY, USA.

Alexander Fleming (A)

Kinexum Services LLC, Harpers Ferry, WV, USA.

Alan D Cherrington (AD)

Department of Molecular Physiology and Biophysics, Vanderbilt University School of Medicine-Basic Sciences, Nashville, TENN, USA.

Shashank Joshi (S)

Consultant Endocrinologist, Joshi Clinic and Lilavati Hospital, Mumbai, India.

Sandeep N Athalye (SN)

Clinical Development and Medical Affairs, Biocon Biologics Limited, Bengaluru, Karnataka, India.

Subramanian Loganathan (S)

Clinical Development and Medical Affairs, Biocon Biologics Limited, Bengaluru, Karnataka, India.

Ashwini Vishweswaramurthy (A)

Clinical Development and Medical Affairs, Biocon Biologics Limited, Bengaluru, Karnataka, India.

Jayanti Panda (J)

Clinical Development and Medical Affairs, Biocon Biologics Limited, Bengaluru, Karnataka, India.

Ashwani Marwah (A)

Clinical Development and Medical Affairs, Biocon Biologics Limited, Bengaluru, Karnataka, India.

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Classifications MeSH