A Multicenter, Randomized, Open-label, Two-arm, Phase 4 Study to Evaluate the Effect of Add-on Pioglitazone or Dapagliflozin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled by Dipeptidyl Peptidase-4 Inhibitor and Metformin Therapy

The purpose of this study is to assess the pioglitazone plus alogliptin plus metformin is non-inferior to dapagliflozin plus alogliptin plus metformin on glycosylated haemoglobin (HbA1c) change from baseline at Week 26.

Start Date11 Feb 2020

Sponsor / Collaborator

Celltrion Pharm Inc.

NCT03501277 / CompletedPhase 1

A Randomized, Open-Label, Single-Dose, 4-Period Crossover Study to Determine the Bioequivalence of Alogliptin (25 mg) and Pioglitazone (15 and 30 mg) When Administered as Individual Tablets and as Fixed-Dose Combination Tablets to Healthy Russian Subjects

The purpose of this study is to assess the relative bioavailability and bioequivalence of 2 strengths of the FDC tablet product SYR-322-4833 BL compared to the individual alogliptin and pioglitazone tablets in healthy Russian participants.

Start Date26 May 2018

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT02763007 / TerminatedPhase 4IIT

An Extension Study of Protocol ALO-IIT(PEAK Study) to Examine the Long-term Efficacy and Safety of Metformin + Alogliptin + Pioglitazone Triple Combination Therapy in the Korean Type 2 Diabetes Patients

Double blind, three arm, comparative intervention trial for 24 weeks(PEAK study) with open label extension trial for 28 weeks followed by 2 year observational study.

Start Date18 May 2016

Sponsor / Collaborator

The Catholic University of Korea Seoul St. Marys Hospital

[+1]

100 Clinical Results associated with Alogliptin Benzoate/Pioglitazone Hydrochloride

100 Translational Medicine associated with Alogliptin Benzoate/Pioglitazone Hydrochloride

100 Patents (Medical) associated with Alogliptin Benzoate/Pioglitazone Hydrochloride

Literatures (Medical) associated with Alogliptin Benzoate/Pioglitazone Hydrochloride

01 Nov 2023·Journal of Affective Disorders

Low-dose lithium adjunct to quetiapine improves cognitive task performance in mice with MK801-induced long-term cognitive impairment: Evidence from a pilot study

Article

Author: Cheng, Langlang ; Fang, Tao ; Chen, Guangdong ; Sun, Yun ; Zhuo, Chuanjun ; Ping, Jing ; Tian, Hongjun ; Wang, Lina ; Zhu, Jingjing ; Chen, Chunmian

BACKGROUNDLow-dose lithium (LD-Li) has been shown to rescue cognitive impairment in mouse models of short-term mild cognitive impairment, dementia, and schizophrenia. However, few studies have characterized the effects of LD-Li, alone or in conjunction with anti-psychotics, in the mouse model of MK801-induced long term cognitive impairment.METHODSThe present study used in vivo Ca²⁺ imaging and a battery of cognitive function assessments to investigate the long-term effects of LD-Li on cognition in mice exposed to repeated injections of MK801. Prefrontal Ca²⁺ activity was visualized to estimate alterations in neural activity in the model mice. Pre-pulse inhibition (PPI), novel object recognition (NOR), Morris water maze (MWM), and fear conditioning (FC) tasks were used to characterize cognitive performance; open field activity (OFA) testing was used to observe psychotic symptoms. Two treatment strategies were tested: LD-Li [250 mg/d human equivalent dose (HED)] adjunct to quetiapine (QTP; 600 mg/d HED); and QTP-monotherapy (mt; 600 mg/d HED).RESULTSCompared to the QTP-mt group, the LD-Li + QTP group showed greatly improved cognitive performance on all measures between experimental days 29 and 85. QTP-mt improved behavioral measures compared to untreated controls, but the effects persisted only from day 29 to day 43. These data suggest that LD-Li + QTP is superior to QTP-mt for improving long-term cognitive impairments in the MK801 mouse model.LIMITATIONSThere is no medical consensus regarding lithium use in patients with schizophrenia.CONCLUSIONMore pre-clinical and clinical studies are needed to further investigate effective treatment strategies for patients with long-term cognitive impairments, such as chronic schizophrenia.

03 Oct 2023·Journal of Chromatographic Science

An Effective Chromatographic Method for Simultaneous Quantification of Antidiabetic Drugs Alogliptin Benzoate and Pioglitazone HCl in Their Tablet Dosage Form: Implementation toIn vitroDissolution Studies and Uniformity of Dosage Unit

Article

Author: Mohamed, Mahmoud A

AbstractIn patients with Type 2 diabetes, a combination of Alogliptin and Pioglitazone medications, together with diet and physical activity, are used to improve glycemic control. Eco-friendly, cost-effective, and precise stability-indicating RP-HPLC method was developed and validated for the identification and quantification of Alogliptin and Pioglitazone in their tablet dosage form, as well as implementation to in vitro dissolution studies and uniformity of dosage unit. Isocratic separation is conducted at ambient temperature on the InertSustain C18 Analytical Column (150 × 4.6 mm, 5 μm) using mobile phase comprising 50 mM of ammonium dihydrogen phosphate and 5.0 mM of heptane sulfonic acid:acetonitrile (45:55, v/v) at a flow rate of 1.3 mL/minute. Calibration curves are conducted in the linearity range of 1–40 μg/mL of Alogliptin and 2.5–75 μg/mL of Pioglitazone with a correlation value >0.9995 and satisfactory recovery findings between 99 and 100%. The degraded samples are analyzed under relevant stress conditions as acidity, alkalinity, thermal and oxidation. The active components in finished products were subjected to a content uniformity test, which showed that they achieved the declared claim’s acceptance standards (85–115%). Comparative in vitro dissolution studies are performed for generic products Inhibazone 12.5/30 mg FCT and Inhibazone 25/15 mg FCT against innovator products Oseni 12.5/30 mg FCT and Oseni 25/15 mg FCT at suitable FDA dissolution medium and different USP dissolution media and the results are similar. The metrics of the designed method were assessed according to ICH requirements, and all metrics, such as system suitability, linearity, recovery, robustness, LOD, LOQ, specificity and precision, were found to be within required tolerances and no overlapping was found for degradation peaks. Thence, the method can be used in quality control for the analysis of raw material, bulk, finish and stability.

01 Nov 2019·Journal of Chromatography BQ3 · MEDICINE

Determination of pioglitazone, its metabolite and alogliptin in human plasma by a novel LC-MS/MS method; application to a pharmacokinetic study

Q3 · MEDICINE

Article

Author: Rezk, Mamdouh R ; Elghobashy, Mohamed R ; Kelani, Khadiga M ; Badran, Osama M

A novel, high throughput and sensitive LC-MS/MS assay method was developed and fully validated for quantitative determination of pioglitazone, its hydroxyl metabolite and alogliptin in human plasma. A simple and rapid sample preparation procedure based on protein precipitation technique with acetonitrile was utilized. Chromatographic separation was achieved on C₈ (50 × 4.6 mm, 5 μm) Kinetex® analytical column using methanol and 0.1% formic acid in a gradient elution mode at a flow rate of 0.7 mL/min with injection volume of 8 μL. Detection was performed on a triple quadrupole mass spectrometer accompanied with electrospray ionization (ESI) technique in positive mode, operating in multiple reaction monitoring, with the transitions of 357.2 → 119.1, 373.1 → 150.1, 340.3 → 116.1, 361.1 → 138.1 and 343.2 → 116.1 m/z for pioglitazone, its hydroxyl metabolite, alogliptin, pioglitazone-d4 (IS-1) and alogliptin-d3 (IS-2), in order. Analysis was achieved within 4 min over a linear concentration range of 10-3000 ng/mL, 5-2000 ng/mL and 3-300 ng/mL, for pioglitazone, hydroxyl pioglitazone and alogliptin, in order. The method was fully validated according to FDA guidelines. The developed method was used for estimation of the three studied analytes in human plasma and pharmacokinetic parameters were demonstrated after oral dose administration of Oseni® tablets to Egyptian healthy volunteers.

News (Medical) associated with Alogliptin Benzoate/Pioglitazone Hydrochloride

23 Sep 2022

·www.healthcareitnews.com

South Korea's Myongji Hospital to develop robots that support dementia patients

Myongji Hospital, a tertiary healthcare institution in South Korea's Gyeonggi Province, is developing an AI-driven care robot to assist patients with dementia. The AI robot called "PIO" will be developed as part of a recently-signed technology development agreement with Whydots, a local robot maker. WHAT IT'S ABOUT The PIO robot, which resembles a parrot, aims to stimulate attachment and emotions in early dementia patients. It has a camera that recognises its user's face and facial expressions and is able to express emotions through its LED eyes and body movements. In its development, Myongji will contribute its experience and clinical data of dementia patients accumulated from the Baekse-chongmyung School, which runs the hospital's community-based dementia management programme. The hospital will also craft cognitive intervention content. WHY IT MATTERS According to a press statement, PIO can help relieve depression and improve users' emotional stability and cognitive ability. An initial trial of the technology early this year found that it helped improve the emotional condition and mental ability of patients at the Baekse-chongmyung School. It also received high satisfaction from users. PIO is also expected to reduce the workload for nursing personnel by interacting with patients while supporting the management of their condition. THE LARGER TREND Local governments in South Korea have provided companion robots to single persons and those who are living with mental health issues to support their well-being. The government of Chungnam Province , for one, is currently trying out AI-based care robots, which have been deployed to help communicate with single residents and people living with mental health issues as part of its suicide prevention efforts. The Gwanak district in Seoul followed suit by deploying the AI robot called Channy to serve as a personal companion for single adults in their community. ON THE RECORD South Korea's senior population is fast growing, making up about 16% of the total population or 8.53 million last year. According to Statistics Korea, this rising trend could continue, possibly reaching around 13 million in 2030 and 17 million in 2040. By 2050, people aged 65 and older will potentially account for over 40% of the entire population. "As the number of dementia patients is expected to increase due to the rapid ageing of the population, proper and effective treatment and management of dementia is urgently needed," said Myongji Hospital Director Kim Jin-gu. He added that the Myongji Hospital will continue to develop technology and produce content for dementia-friendly AI care robots with its know-how and expertise acquired from operating the Baekse-chongmyung School.

Collaborate

100 Deals associated with Alogliptin Benzoate/Pioglitazone Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10BD09	-

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	US	Takeda Pharmaceuticals U.S.A., Inc.	25 Jan 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01395797 (CTgov)	Phase 1/2	Heroin Dependence \| Nicotine Dependence	82	Placebo (Placebo - Heroin)	ottdieuvgg(vzufxjklqq) = jxtzqqokuv ilcoxdxtju (kolclahmjv, ksfiupyjcj - sgfiryjgvh) View more	-	13 Jul 2017
				PIO (Pio High Dose - Heroin)	ottdieuvgg(vzufxjklqq) = icdnzzdufv ilcoxdxtju (kolclahmjv, kxkildklgj - xehrlmkarn) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis