Miglitol

Overview

Miglitol inhibits the breakdown complex carbohydrates into glucose. It is primarily used in diabetes mellitus type 2 for establishing greater glycemic control by preventing the digestion of carbohydrates (such as disaccharides, oligosaccharides, and polysaccharides) into monosaccharides which can be absorbed by the body. Miglitol should be taken at the start of a meal for maximal effect and the effect will depend on the amount of poly and oligosaccharides in the diet. Miglitol inhibits alpha-glucosidase, making less sugars available for digestion and reducing postprandial hyperglycemia. Unlike other drugs of the same class, miglitol is not metabolized and the unmetabolized drug is excreted by the kidneys.

Indication

For use as an adjunct to diet to improve glycemic control in patients with non-insulin-dependent diabetes mellitus (NIDDM) whose hyperglycemia cannot be managed with diet alone.

Associated Conditions

Type 2 Diabetes Mellitus

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol	2010/04/08	NCT01099839	Phase 1	Completed	Astellas Pharma Inc
Double-Blind Study of Miglitol in Japanese With type2 Diabetes	2006/09/27	NCT00380822	Phase 3	Completed	Sanwa Kagaku Kenkyusho Co., Ltd.
Double-Blind Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide	2006/06/07	NCT00334399	Phase 3	Completed	Sanwa Kagaku Kenkyusho Co., Ltd.
Open Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide	2006/06/07	NCT00334503	Phase 3	Completed	Sanwa Kagaku Kenkyusho Co., Ltd.
Double-Blind Trial of Miglitol in Type 2 Diabetic Patients With Insulin Treatment	2005/09/21	NCT00213070	Phase 3	Completed	Sanwa Kagaku Kenkyusho Co., Ltd.
Open Trial of Miglitol in Type 1 Diabetic Patients With Insulin Treatment	2005/09/21	NCT00213109	Phase 3	Completed	Sanwa Kagaku Kenkyusho Co., Ltd.
Effects of Miglitol on Daily Plasma Glucose in type2 Diabetes Treated With Insulin	2005/09/21	NCT00213122	Phase 3	Completed	Sanwa Kagaku Kenkyusho Co., Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Miglitol	Proficient Rx LP	71205-936	ORAL	50 mg in 1 1	4/1/2022
Miglitol	Orient Pharma Co., Ltd.	76333-127	ORAL	100 mg in 1 1	10/23/2019
Miglitol	Westminster Pharmaceuticals, LLC	69367-305	ORAL	100 mg in 1 1	12/7/2021
Miglitol	Proficient Rx LP	71205-937	ORAL	100 mg in 1 1	4/1/2022
Miglitol	Westminster Pharmaceuticals, LLC	69367-303	ORAL	25 mg in 1 1	12/7/2021
Miglitol	Orient Pharma Co., Ltd.	76333-125	ORAL	25 mg in 1 1	10/23/2019
Miglitol	Orient Pharma Co., Ltd.	76333-126	ORAL	50 mg in 1 1	10/23/2019
Miglitol	Westminster Pharmaceuticals, LLC	69367-304	ORAL	50 mg in 1 1	12/7/2021
Miglitol	Proficient Rx LP	71205-935	ORAL	25 mg in 1 1	4/1/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
PLUMAROL 50 mg COMPRIMIDOS	Lacer S.A.	62701	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
PLUMAROL 100 mg COMPRIMIDOS	Lacer S.A.	62702	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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