Miglitol

In contrast to sulfonylureas, miglitol tablets do not enhance insulin secretion. The antihyperglycemic action of miglitol results from a reversible inhibition of membrane-bound intestinal α-glucoside hydrolase enzymes.

• Miglitol tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.ICD-10: E11.9

• Miglitol tablets are contraindicated in patients with: Diabetic ketoacidosis Inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction, and in patients predisposed to intestinal obstruction Chronic intestinal diseases associated with marked disorders of digestion or absorption, or with conditions that may deteriorate as a result of increased gas formation in the intestine Hypersensitivity to the drug or any of its componentscontraindicated

There is no fixed dosage regimen for the management of diabetes mellitus with miglitol tablets or any other pharmacologic agent. Dosage of miglitol tablets must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended dosage of 100 mg 3 times daily. Miglitol tablets should be taken three times daily at the start of each main meal. Miglitol tablets should be started at 25 mg, and the dosage gradually increased both to reduce gastrointestinal adverse effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. During treatment initiation and dose titration, one-hour postprandial plasma glucose may be used to determine the therapeutic response to miglitol tablets and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately 3 months. The therapeutic goal should be to decrease both postprandial plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of miglitol tablets, either as monotherapy or in combination with a sulfonylurea. Initial Dosage The recommended starting dosage of miglitol tablets is 25 mg, given orally three times daily at the start of each main meal. However, some patients may benefit by starting at 25 mg once daily to minimize gastrointestinal adverse effects, and gradually increasing the frequency of administration to 3 times daily.

Gastrointestinal Gastrointestinal symptoms are the most common reactions to miglitol tablets. In U.S. placebo-controlled trials, the incidences of abdominal pain, diarrhea, and flatulence were 11.7%, 28.7%, and 41.5% respectively in 962 patients treated with miglitol tablets, 25 mg to 100 mg 3 times daily, whereas the corresponding incidences were 4.7%, 10.0%, and 12.0% in 603 placebo-treated patients. The incidence of diarrhea and abdominal pain tended to diminish with continued treatment. Dermatologic Skin rash was reported in 4.3% of patients treated with miglitol tablets compared to 2.4% of placebo-treated patients. Rashes were generally transient and most were assessed as unrelated to miglitol tablets by physician investigators. Abnormal Laboratory Findings Low serum iron occurred more often in patients treated with miglitol tablets (9.2%) than in placebo-treated patients (4.2%) but did not persist in the majority of cases and was not associated with reductions in hemoglobin or changes in other hematologic indices. Postmarketing Experience The following adverse reactions have been reported during post-approval use of miglitol tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders: ileus (including paralytic ileus), subileus, gastrointestinal pain, nausea, abdominal distention.

Pregnancy Teratogenic Effects Pregnancy Category B The safety of miglitol tablets in pregnant women has not been established. Developmental toxicology studies have been performed in rats at doses of 50, 150 and 450 mg/kg, corresponding to levels of approximately 1.5, 4, and 12 times the maximum recommended human exposure based on body surface area. In rabbits, doses of 10, 45, and 200 mg/kg corresponding to levels of approximately 0.5, 3, and 10 times the human exposure were examined. These studies revealed no evidence of fetal malformations attributable to miglitol. Doses of miglitol up to 4 and 3 times the human dose (based on body surface area), for rats and rabbits respectively, did not reveal evidence of impaired fertility or harm to the fetus. The highest doses tested in these studies, 450 mg/kg in the rat and 200 mg/kg in the rabbit promoted maternal and/or fetal toxicity. Fetotoxicity was indicated by a slight but significant reduction in fetal weight in the rat study and slight reduction in fetal weight, delayed ossification of the fetal skeleton and increase in the percentage of non-viable fetuses in the rabbit study. In the peri-postnatal study in rats, the NOAEL (No Observed Adverse Effect Level) was 100 mg/kg (corresponding to approximately four times the exposure to humans, based on body surface area).

Metabolism

Absorption Absorption of miglitol is saturable at high doses: a dose of 25 mg is completely absorbed, whereas a dose of 100 mg is 50% to 70% absorbed. For all doses, peak concentrations are reached in 2 to 3 hours.

Unlike sulfonylureas or insulin, an overdose of miglitol tablets will not result in hypoglycemia. An overdose may result in transient increases in flatulence, diarrhea, and abdominal discomfort. Because of the lack of extra-intestinal effects seen with miglitol tablets, no serious systemic reactions are expected in the event of an overdose.

• Feb 24, 2015ANDAANDA203965Orient Pharma

1. 1Hypoglycaemia687.3%
2. 2Hepatic Function Abnormal475.0%
3. 3Decreased Appetite394.2%
4. 4Diarrhoea374.0%
5. 5Renal Impairment363.9%
6. 6Liver Disorder343.6%
7. 7Diabetes Mellitus293.1%
8. 8Nausea283.0%
9. 9Off Label Use272.9%
10. 10Drug Interaction262.8%
11. 11Alanine Aminotransferase Increased252.7%
12. 12Hyperglycaemia252.7%
13. 13Platelet Count Decreased252.7%
14. 14Diabetes Mellitus Inadequate Control242.6%
15. 15Cardiac Failure222.4%

The 10 most recently updated of 14 ClinicalTrials.gov registrations naming Miglitol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
  Completed · Observational · 714,582 enrolled · Janssen Research & Development, LLC
  NCT03492580updated 2025-06-25
• A Study to Assess the Safety and Efficacy of ASP1941 in Combination With α-glucosidase Inhibitor in Type 2 Diabetic Patients
  Completed · Phase 3 · Interventional · 113 enrolled · Astellas Pharma Inc
  NCT01242202updated 2025-05-30
• Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh
  Not yet recruiting · Phase 4 · Interventional · 938 enrolled · Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
  NCT06449235updated 2024-07-16
• Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)
  Completed · Phase 3 · Interventional · 585 enrolled · Merck Sharp & Dohme LLC
  NCT01697592updated 2018-09-10
• Incretin-based Drugs and Acute Pancreatitis
  Completed · Observational · 1,417,914 enrolled · Canadian Network for Observational Drug Effect Studies, CNODES
  NCT02476760updated 2016-11-03
• Incretin-based Drugs and the Risk of Heart Failure
  Completed · Observational · 1,499,650 enrolled · Canadian Network for Observational Drug Effect Studies, CNODES
  NCT02456428updated 2016-04-19
• Incretin-based Drugs and Pancreatic Cancer
  Completed · Observational · 886,172 enrolled · Canadian Network for Observational Drug Effect Studies, CNODES
  NCT02475499updated 2016-03-14
• A Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol
  Completed · Phase 1 · Interventional · 30 enrolled · Astellas Pharma Inc
  NCT01099839updated 2010-06-09
• Double-Blind Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide
  Completed · Phase 3 · Interventional · Sanwa Kagaku Kenkyusho Co., Ltd.
  NCT00334399updated 2008-10-10
• Open Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide
  Completed · Phase 3 · Interventional · Sanwa Kagaku Kenkyusho Co., Ltd.
  NCT00334503updated 2008-10-10

Frequently asked questions

How does Miglitol work?

In contrast to sulfonylureas, miglitol tablets do not enhance insulin secretion. The antihyperglycemic action of miglitol results from a reversible inhibition of membrane-bound intestinal α-glucoside hydrolase enzymes.

What is Miglitol used for?

According to FDA labeling, Miglitol carries indications including: Miglitol tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Miglitol?

Miglitol is classified as Alpha glucosidase inhibitors, alpha-Glucosidase Inhibitor, alpha Glucosidase Inhibitors, Inhibition Carbohydrate Digestion.

What are the contraindications for Miglitol?

Miglitol labeling lists contraindications including: Miglitol tablets are contraindicated in patients with: Diabetic ketoacidosis Inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction, and in patients predisposed to intestinal obstruction Chronic intestinal diseases associated with marked disorders of digestion or absorption, or with conditions that may deteriorate as a result of increased gas formation in the intestine Hypersensitivity to the drug or any of its components. Always consult the full prescribing information and a clinician.