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NCT02467790

Kinetic Study of Human Pharmacokinetics in Normal Renal Function, and Renal Insufficiency Subject of Polyethylene Glycol Loxenatide (PEX168)(Open, Non-randomized, Parallel-group)

Status unknown Phase 1 Last updated 23 January 2016
What this trial tests

Phase 1 trial testing PEX168 in Type 2 Diabetes Mellitus in 24 participants. Status unknown.

Timeline
1 February 2015
Primary endpoint
1 March 2016
1 May 2016

Quick facts

Lead sponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment24
Start date1 February 2015
Primary completion1 March 2016
Estimated completion1 May 2016
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 31 to 65, any sex, with Type 2 Diabetes Mellitus. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

To compare and analysis pharmacokinetics of PEX 168 in patients with renal insufficiency or normal renal function who were administrated subcutaneously single dose PEX168.To evaluate dose adjustment of PEX168 administered in patients with renal insufficiency and provide a scientific basis in patients with renal insufficiency of rational drug use.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Polyethylene glycol loxenatide (PEX168) in subjects with renal impairment: A pharmacokinetic study.
    Wang J, Huang J, Li W, Tang S, et al · · 2019 · cited 14× · PMID 31396983 · DOI 10.1111/bcp.14091
  2. Research Progress on Peptide Drugs for Type 2 Diabetes and the Possibility of Oral Administration.
    Yang X, Lin R, Feng C, Kang Q, et al · · 2024 · cited 2× · PMID 39598478 · DOI 10.3390/pharmaceutics16111353

Verify or expand the search:

Other trials of PEX168

Trials testing the same drug.

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

Other Jiangsu Hansoh Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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