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A 52‐week randomized controlled trial of ipragliflozin or sitagliptin in type 2 diabetes combined with metformin: The <scp>N‐ISM</scp> study
- Source :
- Diabetes, Obesity & Metabolism
- Publication Year :
- 2021
- Publisher :
- Wiley, 2021.
-
Abstract
- Aim To compare the long‐term efficacy of sodium‐glucose co‐transporter‐2 inhibitors and dipeptidyl peptidase‐4 inhibitors as second‐line drugs after metformin for patients not at high risk of atherosclerotic cardiovascular disease (ASCVD). Materials and methods In a 52‐week randomized open‐label trial, we compared ipragliflozin and sitagliptin in Japanese patients diagnosed with type 2 diabetes, without prior ASCVD and treated with metformin. The primary endpoint was a glycated haemoglobin (HbA1c) reduction of ≥0.5% (5.5 mmol/mol) without weight gain at 52 weeks. Results Of a total of 111 patients (mean age 59.2 years, mean body mass index [BMI] 26.6 kg/m2, 61.3% men), 54 patients received ipragliflozin and 57 received sitagliptin. After 52 weeks, achievement of the primary endpoint was not significantly different (37.0% and 40.3%; P = 0.72). HbA1c reduction rate at 24 weeks was greater for sitagliptin (56.1%) than for ipragliflozin (31.5%; P = 0.01). From 24 to 52 weeks, the HbA1c reduction with sitagliptin was attenuated, with no significant difference in HbA1c reduction after 52 weeks between sitagliptin (54.4%) and ipragliflozin (38.9%; P = 0.10). Improvements in BMI, C‐peptide and high‐density lipoprotein cholesterol were greater with ipragliflozin than with sitagliptin. Adverse events occurred in 17 patients with ipragliflozin and in 10 patients with sitagliptin (P = 0.11). Conclusion The HbA1c‐lowering effect at 24 weeks was greater with sitagliptin than with ipragliflozin, but with no difference in efficacy related to HbA1c and body weight at 52 weeks. However, some ASCVD risk factors improved with ipragliflozin.
- Subjects :
- Male
Endocrinology, Diabetes and Metabolism
Type 2 diabetes
030204 cardiovascular system & hematology
law.invention
chemistry.chemical_compound
0302 clinical medicine
Endocrinology
Glucosides
Randomized controlled trial
law
randomized trial
Clinical endpoint
clinical trial
DPP‐4 inhibitor
SGLT2 inhibitor
Middle Aged
Metformin
Treatment Outcome
glycaemic control
Sitagliptin
Drug Therapy, Combination
Female
Original Article
medicine.drug
medicine.medical_specialty
Urology
030209 endocrinology & metabolism
Thiophenes
sitagliptin
03 medical and health sciences
Double-Blind Method
Internal Medicine
medicine
Humans
Hypoglycemic Agents
Adverse effect
Glycated Hemoglobin
Dipeptidyl-Peptidase IV Inhibitors
business.industry
Sitagliptin Phosphate
nutritional and metabolic diseases
Original Articles
medicine.disease
Ipragliflozin
Diabetes Mellitus, Type 2
chemistry
business
Body mass index
Subjects
Details
- ISSN :
- 14631326 and 14628902
- Volume :
- 23
- Database :
- OpenAIRE
- Journal :
- Diabetes, Obesity and Metabolism
- Accession number :
- edsair.doi.dedup.....44e37aada2e0798c2d58e9bcbb94aefc