PMID- 29770541 OWN - NLM STAT- MEDLINE DCOM- 20190205 LR - 20190730 IS - 1463-1326 (Electronic) IS - 1462-8902 (Linking) VI - 20 IP - 9 DP - 2018 Sep TI - Effect of short-term treatment with sitagliptin or glibenclamide on daily glucose fluctuation in drug-naive Japanese patients with type 2 diabetes mellitus. PG - 2274-2281 LID - 10.1111/dom.13364 [doi] AB - AIMS: To compare the effect of a dipeptidyl peptidase-4 inhibitor (DPP4-i) and a sulfonylurea (SU) on daily glucose fluctuation in drug-naive Japanese patients with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: A total of 53 drug-naive Japanese patients with T2DM (HbA1c, 7.0%-9.0%; fasting plasma glucose, 6.1 mmol/L or higher) were randomly assigned to either sitagliptin 50 mg qd or glibenclamide 2.5 mg per day (given in divided doses) in a 1:1 ratio. A continuous glucose monitoring (CGM) device was used to obtain 24-hour glucose profiles for each patient at baseline and at Week 2. The primary study endpoint was change from baseline in mean amplitude of glucose excursion (MAGE) during a 24-hour period. A key secondary endpoint was change from baseline in the standard deviation (SD) of 24-hour glucose levels. RESULTS: After 2 weeks of treatment, a numerically greater reduction in MAGE from baseline was observed in the sitagliptin group compared with the glibenclamide group, but the between-treatment difference was not statistically significant (LS mean difference [95% CI]: -0.48 mmol/L [-1.31, 0.34]; P = .245). However, a significantly greater reduction in the change from baseline in SD was observed in the sitagliptin group compared with the glibenclamide group (LS mean difference [95% CI]: -0.33 mmol/L [-0.62, -0.03]; P = .029). CONCLUSIONS: This study suggests that the DPP4 inhibitor sitagliptin has a greater ability to reduce daily glucose fluctuation than the SU glibenclamide in drug-naive Japanese patients with T2DM. ClinicalTrials.gov: NCT02318693. CI - (c) 2018 John Wiley & Sons Ltd. FAU - Suzuki, Ryo AU - Suzuki R AD - Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. FAU - Eiki, Jun-Ichi AU - Eiki JI AUID- ORCID: 0000-0002-1622-6114 AD - Medical Affairs, and Biostatistics and Research Decision Sciences, MSD K.K, Tokyo, Japan. FAU - Moritoyo, Takashi AU - Moritoyo T AD - Phase 1 Unit, Clinical Research Support Center, The University of Tokyo Hospital, Tokyo, Japan. FAU - Furihata, Kenichi AU - Furihata K AD - P-one Clinic, Keikokai Medical Corporation, Tokyo, Japan. FAU - Wakana, Akira AU - Wakana A AD - Medical Affairs, and Biostatistics and Research Decision Sciences, MSD K.K, Tokyo, Japan. FAU - Ohta, Yukari AU - Ohta Y AD - Medical Affairs, and Biostatistics and Research Decision Sciences, MSD K.K, Tokyo, Japan. FAU - Tokita, Shigeru AU - Tokita S AD - Medical Affairs, and Biostatistics and Research Decision Sciences, MSD K.K, Tokyo, Japan. FAU - Kadowaki, Takashi AU - Kadowaki T AD - Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. LA - eng SI - ClinicalTrials.gov/NCT02318693 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20180611 PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0 (Blood Glucose) RN - 0 (Dipeptidyl-Peptidase IV Inhibitors) RN - 0 (Hypoglycemic Agents) RN - 0 (Sulfonylurea Compounds) RN - SX6K58TVWC (Glyburide) RN - TS63EW8X6F (Sitagliptin Phosphate) SB - IM MH - Aged MH - Blood Glucose/*analysis MH - Blood Glucose Self-Monitoring MH - Diabetes Mellitus, Type 2/blood/*drug therapy MH - Dipeptidyl-Peptidase IV Inhibitors/administration & dosage MH - Drug Administration Schedule MH - Fasting/blood MH - Female MH - Glyburide/*administration & dosage MH - Humans MH - Hypoglycemic Agents/*administration & dosage MH - Japan MH - Male MH - Middle Aged MH - Sitagliptin Phosphate/*administration & dosage MH - Sulfonylurea Compounds/administration & dosage MH - Treatment Outcome OTO - NOTNLM OT - continuous glucose monitoring OT - daily glucose fluctuation OT - glibenclamide OT - sitagliptin OT - type 2 diabetes mellitus EDAT- 2018/05/18 06:00 MHDA- 2019/02/06 06:00 CRDT- 2018/05/18 06:00 PHST- 2018/01/18 00:00 [received] PHST- 2018/04/29 00:00 [revised] PHST- 2018/05/13 00:00 [accepted] PHST- 2018/05/18 06:00 [pubmed] PHST- 2019/02/06 06:00 [medline] PHST- 2018/05/18 06:00 [entrez] AID - 10.1111/dom.13364 [doi] PST - ppublish SO - Diabetes Obes Metab. 2018 Sep;20(9):2274-2281. doi: 10.1111/dom.13364. Epub 2018 Jun 11.