D-Pinitol Clinical Trials

Size	Price	Qty
25mg	USD 107

Clinical Trials

Multiple completed clinical trials sponsored by an academic institution, the University of Valencia, have evaluated D-pinitol without specifying a standard phase classification. These studies focused on metabolic conditions and parameters, including type 2 diabetes, impaired glucose tolerance, and insulin sensitivity. Additionally, the evaluations assessed carbohydrate, lipid, and inflammatory biomarkers, as well as dosage-dependent metabolic responses in healthy participants.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01754792	Completed	Type 2 Diabetes\|Impaired Glucose Tolerance\|Healthy	University of Valencia	2012-01	Not Applicable
NCT01738763	Completed	Healthy\|Insulin Sensitivity	University of Valencia	2011-07	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

D-pinitol acts as a natural inositol derivative that mimics insulin signaling mediators, thereby modulating downstream intracellular biochemical cascades to regulate glucose and lipid pathways. This molecular effect enhances intracellular glucose utilization and reduces inflammatory mediators, providing therapeutic relevance for clinical conditions such as type 2 diabetes, impaired glucose tolerance, and insulin sensitivity.

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>).