A randomized, placebo‐controlled study to evaluate the efficacy and safety of adding omarigliptin to insulin therapy in Japanese patients with type 2 diabetes and inadequate glycaemic control

Autor: Miho Kameya, Tomona Hirano, Yutaka Seino, Nobuyuki Oshima, Samuel S. Engel, Taro Okamoto, Edward A. O'Neill, Ira Gantz, Takashi Kadowaki, Asako Sato, Kohei Kaku
Rok vydání: 2021
Předmět:
insulin
medicine.medical_specialty
Endocrinology
Diabetes and Metabolism
medicine.medical_treatment
dipeptidyl peptidase‐4
Placebo-controlled study
030209 endocrinology & metabolism
Glycemic Control
Type 2 diabetes
030204 cardiovascular system & hematology
Placebo
Heterocyclic Compounds
2-Ring
03 medical and health sciences
0302 clinical medicine
Endocrinology
Double-Blind Method
Japan
once‐weekly antihyperglycaemic agent
Internal medicine
Internal Medicine
medicine
Humans
Hypoglycemic Agents
Adverse effect
Pyrans
MK‐3102
Glycated Hemoglobin
business.industry
Insulin
Incidence (epidemiology)
Original Articles
medicine.disease
Discontinuation
Clinical trial
Treatment Outcome
Diabetes Mellitus
Type 2
Drug Therapy
Combination
Original Article
oral antihyperglycaemic agent
business
incretins
Zdroj: Diabetes, Obesity & Metabolism
ISSN: 1463-1326
1462-8902
Popis: Aim To evaluate the efficacy and safety of adding the once‐weekly oral dipeptidyl peptidase‐4 inhibitor omarigliptin to treatment of Japanese patients with type 2 diabetes and inadequate glycaemic control on insulin monotherapy. Materials and Methods In a 52‐week clinical trial, Japanese patients on insulin monotherapy were randomized to once‐weekly omarigliptin 25 mg (N = 123) or placebo (N = 61) for a 16‐week, double‐blind, placebo‐controlled period. After Week 16, patients continued or switched to omarigliptin for a 36‐week open‐label period. Results From a mean baseline of approximately 8.8%, the Week 16 least squares mean changes in HbA1c were −0.61% (omarigliptin) and 0.29% (placebo); the between‐group difference was −0.90% (p
Databáze: OpenAIRE
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