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

NCT02180334 | Completed Phase 4 DMC

• 2 other identifiers: H-1311-104-5372013-2641
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Gastric Emptying; Gastrointestinal Motility; Incretins; Glucagon-Like Peptide 1; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) of plasma total GLP-1 levels

  AUC of plasma total GLP-1 levels during MMTT

  0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)

Secondary Outcomes (7)

• Area under the curve (AUC) of plasma total GIP levels

  0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)

• Area under the curve (AUC) of plasma glucose levels

  0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)

• Area under the curve (AUC) of plasma insulin levels

  0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)

• Area under the curve (AUC) of plasma C-peptide levels

  0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)

• Area under the curve (AUC) of serum triglyceride levels

  0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)

Other Outcomes (3)

• Area under the curve (AUC) of plasma paracetamol levels

  0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)

• The peak concentration of plasma paracetamol

  0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)

• The time to peak concentration of plasma paracetamol

  0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)

Study Arms (2)

Mosapride

EXPERIMENTAL

* Mosapride citrate 5 mg (Gasmotin®): 1 tablet (5 mg) will be administered 1 hour before MMTT. * Linagliptin 5 mg (Trajenta®): 1 tablet (5 mg) per day should be taken for 7 days during run-in period. 1 tablet (5 mg) will be administered 1 hour before MMTT. * Acetaminophen 500 mg (Tylenol®): 3 tablets (1500 mg) will be administered at once with the mixed meal for calculating gastric emptying time.

Drug: Mosapride citrate; Drug: Linagliptin; Drug: Acetaminophen (paracetamol)

Control

PLACEBO COMPARATOR

* Placebo drug: 1 tablet will be administered 1 hour before MMTT. * Linagliptin 5 mg (Trajenta®): 1 tablet (5 mg) per day should be taken for 7 days during run-in period. 1 tablet (5 mg) will be administered 1 hour before MMTT. * Acetaminophen 500 mg (Tylenol®): 3 tablets (1500 mg) will be administered at once with the mixed meal for calculating gastric emptying time.

Drug: Linagliptin; Drug: Acetaminophen (paracetamol)

Interventions

Mosapride citrate DRUG

On the day of MMTT, 1 tablet (5 mg) of mosapride will be administered orally to participants of 'mosapride' arm. After 1 hour, MMTT will be performed.

Also known as: Gasmotin®

Mosapride

Linagliptin DRUG

During run-in period, 1 tablet (5mg) per day will provided for 7 days. On the day of MMTT, 1 tablet (5 mg) of linagliptin will be administered orally to participants of both arms. After 1 hour, MMTT will be performed.

Also known as: Trajenta®

Control; Mosapride

Acetaminophen (paracetamol) DRUG

On the day of MMTT, 3 tablets (1500 mg) of acetaminophen (paracetamol) will be administered orally to participants of both arms at the start of MMTT with manufactured mixed meal (0 min).

Also known as: Tylenol®

Control; Mosapride

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

mosapride; Linagliptin; Acetaminophen

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Young Min Cho, MD, PHD

  Seoul National University College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 2, 2014
• Study Start: July 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: April 1, 2015
• Last Updated: November 29, 2017

Record last verified: 2014-06

Locations

KR (1)