Clinical Trials

Multiple clinical trials evaluate glipizide across metabolic and oncologic indications. A completed Phase 3 study sponsored by Merck Sharp & Dohme LLC investigated glipizide in patients with type 2 diabetes mellitus and end-stage kidney disease. Additionally, an active Phase 2 trial sponsored by Memorial Sloan Kettering Cancer Center is currently recruiting participants to evaluate sulfonylurea safety and effectiveness in patients presenting with hyperglycemia and metastatic pancreatic ductal adenocarcinoma.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06168812 Recruiting
Pancreatic Cancer|Pancreatic Carcinoma|Pancreatic Ductal Adenocarcinoma|Pancreatic Cancer Metastatic|Metastatic Pancreatic Cancer|Metastatic Pancreatic Ductal Adenocarcinoma
Memorial Sloan Kettering Cancer Center
2023-12-05 Phase 2
NCT00509236 Completed
Diabetes Mellitus Type 2|End-Stage Kidney Disease
Merck Sharp & Dohme LLC
2007-10-19 Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Glipizide selectively binds to ATP-sensitive potassium channels on pancreatic beta cells, blocking channel activity to induce cell membrane depolarization and stimulate voltage-gated calcium influx. This elevation in intracellular calcium triggers the exocytosis of insulin granules, thereby promoting peripheral glucose uptake and lowering blood sugar levels in patients with type 2 diabetes mellitus and hyperglycemia associated with pancreatic cancer.

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>).

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