Mitiglinide Calcium Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Several completed Phase 1 and Phase 4 clinical trials sponsored by industry partners, such as Orient Europharma Co. Ltd., Astellas Pharma Inc., and Elixir Pharmaceuticals, have evaluated mitiglinide calcium for managing type 2 diabetes mellitus. These studies investigated the drug's safety, pharmacokinetics, pharmacodynamics, and drug-drug interactions with ASP1941 and gemfibrozil in both healthy volunteers and diabetic patients with hepatic dysfunction. Together, these trials provide critical insights into the overall pharmacological profile of mitiglinide calcium across diverse patient cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04349696	Completed	Type 2 Diabetes Mellitus\|Liver Dysfunction	Orient Europharma Co. Ltd.	2014-02-11	Phase 4
NCT01403818	Completed	Healthy\|Pharmacokinetics of ASP1941\|Pharmacokinetics of Mitiglinide	Astellas Pharma Inc	2011-06	Phase 1
NCT00566865	Completed	Type 2 Diabetes Mellitus	Elixir Pharmaceuticals	2007-11	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mitiglinide calcium functions as an anti-diabetic agent that binds to and closes ATP-sensitive potassium channels in pancreatic beta-cells, triggering cell membrane depolarization, voltage-gated calcium influx, and rapid insulin secretion. By stimulating immediate insulin release through this targeted channel inhibition, mitiglinide calcium effectively reduces postprandial blood glucose levels, addressing the primary pathophysiological deficit in patients with type 2 diabetes mellitus evaluated in clinical studies.

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>).