Evidence mapPaperPMID 26692004Full record

Trial reportClinical drug investigation2016

Pharmacokinetics and Pharmacodynamics of Henagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, in Chinese Patients with Type 2 Diabetes Mellitus.

Xiaolan Yong, Aidong Wen, Xiangyang Liu, Haiyan Liu, Yan-Ping Liu, Nan Li, Tingting Hu, Ying Chen, Minquan Wang, Lantian Wang and 4 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical drug investigation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Xiaolan YongClinical Pharmacy Lab, General Hospital of Chengdu Military Region PLA, Chengdu, Sichuan, China.
Aidong WenDepartment of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi'an, Shanxi, China.
Xiangyang LiuDepartment of Endocrine and Metabolism, Xijing Hospital, Fourth Military Medical University, Xi'an, Shanxi, China.
Haiyan LiuDepartment of Clinical Medicine, Jiangsu Hengrui Medicine Co., Ltd., Shanghai, 200122, China.
Yan-Ping LiuDepartment of Clinical Medicine, Jiangsu Hengrui Medicine Co., Ltd., Shanghai, 200122, China.
Nan LiClinical Pharmacy Lab, General Hospital of Chengdu Military Region PLA, Chengdu, Sichuan, China.
Tingting HuClinical Pharmacy Lab, General Hospital of Chengdu Military Region PLA, Chengdu, Sichuan, China.
Ying ChenDepartment of Clinical Medicine, Jiangsu Hengrui Medicine Co., Ltd., Shanghai, 200122, China.
Minquan WangDepartment of Clinical Medicine, Jiangsu Hengrui Medicine Co., Ltd., Shanghai, 200122, China.
Lantian WangClinical Pharmacy Lab, General Hospital of Chengdu Military Region PLA, Chengdu, Sichuan, China.
Xiaojiao DaiClinical Pharmacy Lab, General Hospital of Chengdu Military Region PLA, Chengdu, Sichuan, China.
Juan HuangClinical Pharmacy Lab, General Hospital of Chengdu Military Region PLA, Chengdu, Sichuan, China.
Jia LiDepartment of Clinical Medicine, Jiangsu Hengrui Medicine Co., Ltd., Shanghai, 200122, China.
Huaqiong ShenDepartment of Clinical Medicine, Jiangsu Hengrui Medicine Co., Ltd., Shanghai, 200122, China. maoweitaoliu@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveHenagliflozin, a selective inhibitor of the renal sodium glucose cotransporter-2, was developed for type 2 diabetes mellitus (T2DM). This study characterized single- and multiple-dose pharmacokinetics and pharmacodynamics of henagliflozin in Chinese patients with T2DM.

methodsThirty T2DM patients were randomized in a 4:1 ratio to orally receive either henagliflozin 5, 10, 20 mg/day or placebo for 10 days, except on day 2 and day 3. Pharmacokinetic and pharmacodynamic profiles were measured on day 1 and day 10.

resultsHenagliflozin exhibited dose-proportional plasma concentrations with a half-life ranging from 9.1 to 14 h. Steady-state plasma henagliflozin concentration was reached by day 7 in all active treatment groups. Henagliflozin decreased the 24-h mean plasma glucose by -0.3, -1.0 and -1.0 mmol/L with doses of 5, 10 and 20 mg on day 1, respectively. The corresponding values on day 10 were -0.8, -0.9 and -1.2 mmol/L. Twenty-four-hour urinary glucose excretion increased by 11, 65 and 82 times with doses of 5, 10 and 20 mg on day 1, respectively, with a similar trend on day 10. No treatment-related serious adverse events or discontinuations due to adverse events occurred.

conclusionsThe observed pharmacokinetic and pharmacodynamic profiles of henagliflozin support a once-daily dosing regimen in Chinese T2DM patients.

Indexed as

Sodium-Glucose Transporter 2 InhibitorsAdultAsian PeopleBridged Bicyclo Compounds, HeterocyclicDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodFemaleGlucoseHalf-LifeHumansHypoglycemic AgentsMaleMiddle AgedSodium-Glucose Transporter 2Bridged Bicyclo Compounds, HeterocyclicGlucosehenagliflozinHypoglycemic AgentsSLC5A2 protein, humanSodium-Glucose Transporter 2Sodium-Glucose Transporter 2 Inhibitors

Identifiers

What Socratic holds

Textmetadata
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.