Clinical Trials

A completed Phase IV clinical trial evaluated the effectiveness and long-term glycemic control durability of nateglinide in individuals with type 2 diabetes mellitus. Designed as a multi-center, randomized, open-label study comparing nateglinide monotherapy to glimepiride, the trial was sponsored by academic and university hospital institutions, including Ajou University School of Medicine and Korea University Guro Hospital.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00858013 Completed
Type 2 Diabetes Mellitus
Ajou University School of Medicine|Korea University Guro Hospital|Hanyang University|Inha University Hospital|Kyunghee University Medical Center|Myongji Hospital|Bundang CHA Hospital|Wonju Severance Christian Hospital|Hallym University Medical Center
 2009-04-24 Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Nateglinide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nateglinide acts by binding to and closing ATP-dependent potassium channels in pancreatic beta-cell membranes, which induces membrane depolarization and triggers the opening of voltage-gated calcium channels. The subsequent intracellular influx of calcium ions promotes exocytosis of insulin-containing secretory vesicles, thereby stimulating insulin release to lower blood glucose levels in patients with type 2 diabetes mellitus.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.