作者: Schiöth, Helgi B ; Levit, Shmuel ; Koshelev, Daniil ; Kosheleva, Liudmila ; Lagunas-Rangel, Francisco Alejandro ; Rabinovitch, Alexander ; Gavra, Tali

IntroductionThe purpose of this retrospective clinic chart review study was to determine the potential of a combination therapy (CT) consisting of γ-aminobutyric acid (GABA), a dipeptidyl peptidase-4 inhibitor (DPP-4i), and a proton pump inhibitor (PPI) to improve glycemic control as an adjunct to insulin therapy in patients with type 1 diabetes (T1D).Research design and methodsNineteen patients with T1D on insulin therapy were treated with additional CT in oral form. Fasting blood glucose (FBG), HbA1c, insulin dose-adjusted HbA1c (IDA-A1c), daily insulin dose, insulin/weight ratio (IWR), and fasting plasma C-peptide were measured after 26-42 weeks of treatments.ResultsFBG, HbA1c, IDA-A1c, insulin dose and IWR were all significantly decreased while plasma C-peptide was significantly increased by the CT. Treatment outcomes were further analyzed by separation of the 19 patients into two groups. One group started on the CT within 12 months of insulin treatment (early therapy, 10 patients) and another group started on this therapy only after 12 months of insulin treatment (late therapy, 9 patients). FBG, IDA-A1c, insulin dose, and IWR decreased significantly in both the early and late CT groups, however to a better extent in the early therapy group. Moreover, plasma C-peptide increased significantly only in the early therapy group, and 7 of the 10 patients in this group were able to discontinue insulin treatment while maintaining good glycemic control to study end compared with none of the 9 patients in the late therapy group.ConclusionThese results support the concept that the combination of GABA, a DPP-4i and a PPI as an adjunct to insulin therapy improves glycemic control in patients with T1D, and that the insulin dose required for glycemic control can be reduced or even eliminated in some patients receiving this novel therapy.

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适应症	最高研发状态	国家/地区	公司	日期
1型糖尿病	临床2期	以色列	LeviCure Ltd.	2023-05-24

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Front Endocrinol (Lausanne) 人工标引	临床阶段不明	1型糖尿病 plasma C-peptide	19	Combination Therapy (GABA + DPP-4i + PPI), started within 12 months of insulin treatment (early therapy)	(憲獵願遞選選鏇願網繭) = Increased significantly only in the early therapy group. 襯遞鑰獵膚顧製壓齋鹽 (蓋膚餘齋繭構廠廠網齋 ) 更多	积极	2023-05-24
				Combination Therapy (GABA + DPP-4i + PPI), started after 12 months of insulin treatment (late therapy)