PMID- 37853916
OWN - NLM
STAT- MEDLINE
DCOM- 20240214
LR  - 20240214
IS  - 1753-0407 (Electronic)
IS  - 1753-0393 (Print)
IS  - 1753-0407 (Linking)
VI  - 16
IP  - 2
DP  - 2024 Feb
TI  - Impact of chiglitazar on glycemic control in type 2 diabetic patients with 
      metabolic syndrome and insulin resistance: A pooled data analysis from two phase 
      III trials.
PG  - e13484
LID - 10.1111/1753-0407.13484 [doi]
LID - e13484
AB  - BACKGROUND: To evaluate the glycemic control effects of vhiglitazar 
      (carfloglitazar), a novel peroxisome proliferator-activated receptor pan-agonist, 
      in patients with type 2 diabetes mellitus (T2DM) with metabolic syndrome (MetS) 
      or insulin resistance (IR) using pooled data analysis of two phase III clinical 
      trials. METHODS: Data were collected from two randomized phase III clinical 
      trials in China, comparing chiglitazar to placebo or sitagliptin in T2DM 
      patients. The MetS was defined by the Adult Treatment Panel III MetS criteria, 
      and IR was defined by homeostatic model assessment for insulin resistance 
      (HOMA-IR) >/=4.31 (male) or 4.51 (female). The main end point of this analysis was 
      glycemic control in the different arms within each subgroup. RESULTS: In the MetS 
      subgroup, changes in glycated hemoglobin (HbA1c) from baseline at week 24 in the 
      chiglitazar 32 mg, chiglitazar 48 mg, and sitagliptin 100 mg arms were -1.44%, 
      -1.68%, and -1.37%, respectively; p < .05 was obtained when chiglitazar 48 mg was 
      compared with sitagliptin. In the IR subgroup, the changes in HbA1c were -1.58%, 
      -1.56%, and -1.26% in chiglitazar 32 mg, chiglitazar 48 mg, and sitagliptin 
      100 mg arms, respectively; p < .05 was obtained when chiglitazar 32 mg was 
      compared with sitaligptin. The two doses of chiglitazar demonstrated a greater 
      reduction in fasting plasma glucose and 2 h postprandial plasma glucose than 
      sitagliptin in the pooled population and in the MetS and IR subgroups. 
      CONCLUSIONS: Chiglitazar shows promising efficacy for glycemic control in 
      patients with T2DM associated with MetS or IR. Further prospective trials are 
      required to validate these findings.
CI  - (c) 2023 Shenzhen Chipscreen Biosciences Co Ltd. Journal of Diabetes published by 
      Ruijin Hospital, Shanghai JiaoTong University School of Medicine and John Wiley & 
      Sons Australia, Ltd.
FAU - Ning, Zhiqiang
AU  - Ning Z
AD  - Shenzhen Chipscreen Biosciences Co., Ltd., Shenzhen, China.
FAU - Ai, Guoqiang
AU  - Ai G
AD  - Shenzhen Chipscreen Biosciences Co., Ltd., Shenzhen, China.
FAU - Chen, Bo
AU  - Chen B
AD  - Shenzhen Chipscreen Biosciences Co., Ltd., Shenzhen, China.
FAU - Yao, He
AU  - Yao H
AD  - Shenzhen Chipscreen Biosciences Co., Ltd., Shenzhen, China.
FAU - Cao, Haixiang
AU  - Cao H
AUID- ORCID: 0000-0002-9113-5538
AD  - Shenzhen Chipscreen Biosciences Co., Ltd., Shenzhen, China.
FAU - Pan, Desi
AU  - Pan D
AUID- ORCID: 0000-0002-2104-3902
AD  - Shenzhen Chipscreen Biosciences Co., Ltd., Shenzhen, China.
FAU - Lu, Xianping
AU  - Lu X
AD  - Shenzhen Chipscreen Biosciences Co., Ltd., Shenzhen, China.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20231018
PL  - Australia
TA  - J Diabetes
JT  - Journal of diabetes
JID - 101504326
RN  - 0 (chiglitazar)
RN  - 0 (Glycated Hemoglobin)
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
RN  - 0 (Carbazoles)
RN  - 0 (Propionates)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Male
MH  - Female
MH  - *Diabetes Mellitus, Type 2/complications/drug therapy
MH  - *Metabolic Syndrome/complications/drug therapy
MH  - *Insulin Resistance
MH  - Glycated Hemoglobin
MH  - Blood Glucose/metabolism
MH  - Glycemic Control
MH  - Hypoglycemic Agents/therapeutic use
MH  - Sitagliptin Phosphate/therapeutic use
MH  - *Carbazoles
MH  - *Propionates
PMC - PMC10859313
OTO - NOTNLM
OT  - chiglitazar (carfloglitazar)
OT  - insulin resistance
OT  - metabolic syndrome
OT  - peroxisome proliferator-activated receptors pan-agonist
OT  - type 2 diabetes
COIS- The authors are employees of Shenzhen Chipscreen Biosciences, Co., Ltd., the 
      developer and holder of chiglitazar. The authors declare no conflict of interest.
EDAT- 2023/10/19 06:46
MHDA- 2024/02/12 15:42
PMCR- 2023/10/18
CRDT- 2023/10/19 04:00
PHST- 2023/08/24 00:00 [revised]
PHST- 2023/04/18 00:00 [received]
PHST- 2023/09/23 00:00 [accepted]
PHST- 2024/02/12 15:42 [medline]
PHST- 2023/10/19 06:46 [pubmed]
PHST- 2023/10/19 04:00 [entrez]
PHST- 2023/10/18 00:00 [pmc-release]
AID - JDB13484 [pii]
AID - 10.1111/1753-0407.13484 [doi]
PST - ppublish
SO  - J Diabetes. 2024 Feb;16(2):e13484. doi: 10.1111/1753-0407.13484. Epub 2023 Oct 
      18.