Alglucosidase alfa

Generic Name: Alglucosidase alfa

Brand Names: Lumizyme, Myozyme

Drug Type: Biotech

CAS Number: 420784-05-0

Unique Ingredient Identifier: DTI67O9503

Background: Aglucosidase alfa consists of the human enzyme acid alpha-glucosidase (GAA) which is essential for the degradation of glygogen to glucose in lysosomes. It is encoded by the most predominant of nine observed haplotypes of this gene. Aglucosidase alfa is produced by recombinant DNA technology in a Chinese hamster ovary cell line. Alglucosidase alfa degrades glycogen by catalyzing the hydrolysis of a-1,4- and a-1,6- glycosidic linkages of lysosomal glycogen. Structurally, Alglucosidase alfa is a glycoprotein with a calculated mass of 98,008 daltons for the 883 residue mature polypeptide chain, and a total mass of approximately 109,000 daltons, including carbohydrates. It is used for the treatment of Pompe disease (GAA deficiency) in infants and pediatric patients.

Indication: For the treatment of Pompe disease (GAA deficiency) in infants and pediatric patients.

Associated Conditions: Glycogen Storage Disease Type II

Clinical Trials

Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh

Phase 4

Not yet recruiting

Conditions: Type2diabetes

Interventions: Drug: Sulphonylureas
Drug: Alpha-Glucosidase Inhibitor
Drug: Thiazolidinediones
Drug: Omarigliptin
Drug: Other DPP4-i
Drug: SGLT2 inhibitors
Drug: Glucagon-Like Peptide-1
Drug: Receptor Agonists (GLP1RA)
Drug: Metformin

First Posted Date: 2024-06-07

Last Posted Date: 2024-07-16

Lead Sponsor: Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders

Target Recruit Count: 938

Registration Number: NCT06449235

Locations: 🇧🇩
BIRDEM General Hospital, Dhaka, Bangladesh

Higher Dose of Alglucosidase Alpha for Pompe Disease

Not yet recruiting

Conditions: Glycogen Storage Disease Type II

First Posted Date: 2021-08-23

Last Posted Date: 2021-08-23

Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Target Recruit Count: 36

Registration Number: NCT05017402

Study to Evaluate Efficacy and Safety in Chinese Patients With Late Onset Pompe Disease With Alglucosidase Alfa Treatmen

Phase 4

Completed

Conditions: Pompe's Disease

Interventions: Drug: ALGLUCOSIDASE ALFA

First Posted Date: 2020-12-21

Last Posted Date: 2025-02-10

Lead Sponsor: Genzyme, a Sanofi Company

Target Recruit Count: 41

Registration Number: NCT04676373

Locations: 🇨🇳
Investigational Site, China, China

A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: INSULIN GLARGINE (U300)
Drug: metformin
Drug: sulfonylurea
Drug: meglitinides
Drug: thiazolidinediones
Drug: alpha-glucosidase inhibitors
Drug: GLP1 Receptor Agonist
Drug: Dipeptidyl peptidase-IV (DPP-IV) inhibitors
Drug: Sodium-glucose transport-2 (SGLT-2) inhibitors

First Posted Date: 2016-11-03

Last Posted Date: 2019-01-14

Lead Sponsor: Sanofi

Target Recruit Count: 112

Registration Number: NCT02954692

VAL-1221 Delivered Intravenously in Ambulatory and Ventilator-free Participants With Late-Onset Pompe Disease

Phase 1

Terminated

Conditions: Pompe Disease

Interventions: Drug: VAL-1221
Drug: RhGAA

First Posted Date: 2016-09-13

Last Posted Date: 2020-06-02

Lead Sponsor: Valerion Therapeutics, LLC

Target Recruit Count: 12

Registration Number: NCT02898753

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
🇬🇧
National Hospital for Neurology and Neurosurgery, London, United Kingdom
🇺🇸
University of California, Irvine, Orange, California, United States

Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes

Phase 4

Completed

Conditions: Diabetes
Diabetes Mellitus, Type 2

Interventions: Drug: liraglutide
Drug: alpha-glucosidase inhibitors
Drug: DPP-4 inhibitors
Drug: meglitinides
Drug: SGLT-2 inhibitors
Drug: sulphonylurea
Drug: thiazolidinediones

First Posted Date: 2016-04-06

Last Posted Date: 2020-07-07

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 1991

Registration Number: NCT02730377

Locations: 🇹🇷
Novo Nordisk Investigational Site, Istanbul, Turkey

Incretin-based Drugs and Acute Pancreatitis

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Insulins
Drug: Biguanides
Drug: DPP-4 inhibitors
Drug: Sulfonylureas
Drug: GLP-1 analogs
Drug: Thiazolidinediones
Drug: Alpha-glucosidase inhibitors
Drug: Meglitinides

First Posted Date: 2015-06-19

Last Posted Date: 2016-11-03

Lead Sponsor: Canadian Network for Observational Drug Effect Studies, CNODES

Target Recruit Count: 1417914

Registration Number: NCT02476760

Locations: 🇨🇦
Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada

Incretin-based Drugs and Pancreatic Cancer

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: DPP-4 inhibitors
Drug: Sulfonylureas
Drug: Biguanides
Drug: GLP-1 analogs
Drug: Thiazolidinediones
Drug: Alpha-glucosidase inhibitors
Drug: Meglitinides

First Posted Date: 2015-06-18

Last Posted Date: 2016-03-14

Lead Sponsor: Canadian Network for Observational Drug Effect Studies, CNODES

Target Recruit Count: 886172

Registration Number: NCT02475499

Locations: 🇨🇦
Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada

Incretin-based Drugs and the Risk of Heart Failure

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Insulins
Drug: Biguanides
Drug: DPP-4 inhibitors
Drug: GLP-1 analogs
Drug: Sulfonylureas
Drug: Thiazolidinediones
Drug: Alpha-glucosidase inhibitors
Drug: Meglitinides