Miglitol Clinical Trials

Size	Price	Qty
25mg	USD 247

Clinical Trials

Multiple Phase 1 and Phase 3 clinical trials have evaluated miglitol, primarily in subjects with type 2 diabetes mellitus, as well as type 1 diabetes mellitus and healthy volunteers. Sponsored by pharmaceutical companies such as Sanwa Kagaku Kenkyusho Co., Ltd. and Astellas Pharma Inc., these studies examined miglitol as monotherapy, in combination with insulin or biguanides, and for its drug interaction profile. All recorded clinical trials have completed recruitment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01099839	COMPLETED	Healthy Volunteers; Pharmacokinetics of ASP1941	Astellas Pharma Inc	2010-02	PHASE1
NCT01099839	Completed	Healthy Volunteers\|Pharmacokinetics of ASP1941	Astellas Pharma Inc	2010-02	Phase 1
NCT00380822	COMPLETED	Type 2 Diabetes Mellitus	Sanwa Kagaku Kenkyusho Co., Ltd.		PHASE3
NCT00213070	COMPLETED	Type 2 Diabetes Mellitus	Sanwa Kagaku Kenkyusho Co., Ltd.		PHASE3
NCT00334399	COMPLETED	Type 2 Diabetes Mellitus	Sanwa Kagaku Kenkyusho Co., Ltd.		PHASE3
NCT00334503	COMPLETED	Type 2 Diabetes Mellitus	Sanwa Kagaku Kenkyusho Co., Ltd.		PHASE3
NCT00213122	COMPLETED	Type 2 Diabetes Mellitus	Sanwa Kagaku Kenkyusho Co., Ltd.		PHASE3
NCT00213109	COMPLETED	Type 1 Diabetes Mellitus	Sanwa Kagaku Kenkyusho Co., Ltd.		PHASE3

(data from https://clinicaltrials.gov, updated on 2010-06-09)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Miglitol reversibly inhibits intestinal alpha-glucosidase enzymes, thereby preventing the digestion and breakdown of complex carbohydrates into absorbable monosaccharides in the small intestine. This action blunts postprandial blood glucose spikes, providing therapeutic relevance for improving postprandial glycemic control in clinical conditions such as 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>).