The Effect of Combination of Mosapride and DPP-4 Inhibitor on Plasma Concentration of Incretin Hormones

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to investigate the effects of combined administration of mosapride as modulator of gastrointestinal motility and DPP-4 inhibitor on secretion of gut hormone such as glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP), and oral glucose tolerance. Additionally, change in lipid profile and insulin secretion will be also assessed.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Daewoong Pharmaceutical Co. LTD.
• Treatments: Acetaminophen; Citric Acid; Dipeptidyl-Peptidase IV Inhibitors; Gastric Inhibitory Polypeptide; Hormones; Incretins; Linagliptin; Mosapride

Criteria

Inclusion Criteria:

• type 2 diabetes mellitus

• BMI < 35 kg/m2

• HbA1c 6.5~8.0% for whom is on lifestyle modification only, 6.0~8.0% for whom is taking oral antidiabetic drug(s).

• on lifestyle modification or oral antidiabetic therapy (sulfonylurea, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, and DPP-4 inhibitors)

• Who read and signed the informed consent agreement

Exclusion Criteria:

• chronic disease(s) requiring medication other than diabetes mellitus

• type 1 diabetes mellitus or history of diabetic ketoacidosis

• on insulin therapy or requiring insulin therapy

• history of gastrointestinal surgery excluding appendectomy, hernia repair and hemorrhoid surgery

• serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) to be more than 2.5 times above the upper limit of normal

• estimated glomerular filtration rate to be less than 50 mL/min/1.73m2

• genetic disorders associated with digestion and absorption such as galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption

• history of hypersensitivity including anaphylaxis and angioedema to mosapride citrate, linagliptin, or paracetamol (acetaminophen)

• history of asthma associated with aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)

• currently taking drugs that can prolong QT interval, including procainamide, quinidine, flecainide, sotalol, tricyclic antidepressants

• currently taking anticholinergics such as atropine sulfate, scopolamine butylbromide

• child-bearing or lactating women

• women in reproductive age who disagree with contraception with proper method or urine pregnancy test during the study period