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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Mosapride citrate

Linagliptin

Acetaminophen (paracetamol)

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring Gastric Emptying, Gastrointestinal Motility, Incretins, Glucagon-Like Peptide 1, Diabetes Mellitus

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mosapride

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

AUC of plasma total GLP-1 levels during MMTT

Secondary Outcome Measures

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

AUC of plasma total GIP levels during MMTT

Area under the curve (AUC) of plasma glucose levels

AUC of plasma glucose levels during MMTT

Area under the curve (AUC) of plasma insulin levels

AUC of plasma insulin levels during MMTT

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

AUC of plasma C-peptide levels during MMTT

Area under the curve (AUC) of serum triglyceride levels

AUC of serum triglyceride levels during MMTT

Area under the curve (AUC) of serum nonesterified fatty acid (NEFA) levels

AUC of serum NEFA levels during MMTT

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

AUC of plasma active GLP-1 levels during MMTT

Full Information

NCT ID

NCT02180334

First Posted

June 30, 2014

Last Updated

November 27, 2017

Sponsor

Seoul National University Hospital

Collaborators

Daewoong Pharmaceutical Co. LTD.

1. Study Identification

Unique Protocol Identification Number

NCT02180334

Brief Title

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

Official Title

The Effect of Combination of Mosapride and Dipeptidyl Peptidase-4 (DPP-4) Inhibitor on Plasma Concentration of Incretin Hormones

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

Collaborators

Daewoong Pharmaceutical Co. LTD.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This is randomized, double-blind, placebo-controlled, cross-over study. After screening and enrollment, participants will take 5 mg of linagliptin once a day for one week of run-in period (Day 1 to Day 7). Randomization will be done on Day 8 to assign the participants to either mosapride arm or placebo arm. If a subject is assigned to mosapride arm, mixed meal tolerance test (MMTT) will be performed after taking mosapride with linagliptin. If a subject is assigned to placebo arm, he/she will take placebo instead of mosapride before MMTT. On Day 9, all subjects will be crossed over to the other arm and MMTT will proceed with medication depending on their arms. Gastric emptying time measurement with paracetamol will be done along with MMTT. Plasma incretin hormone levels in two arms will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mosapride

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Mosapride citrate

Other Intervention Name(s)

Gasmotin®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Linagliptin

Other Intervention Name(s)

Trajenta®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Acetaminophen (paracetamol)

Other Intervention Name(s)

Tylenol®

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Description

AUC of plasma total GLP-1 levels during MMTT

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

AUC of plasma total GIP levels during MMTT

Time Frame

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

Title

Area under the curve (AUC) of plasma glucose levels

Description

AUC of plasma glucose levels during MMTT

Time Frame

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

Title

Area under the curve (AUC) of plasma insulin levels

Description

AUC of plasma insulin levels during MMTT

Time Frame

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

Title

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

Description

AUC of plasma C-peptide levels during MMTT

Time Frame

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

Title

Area under the curve (AUC) of serum triglyceride levels

Description

AUC of serum triglyceride levels during MMTT

Time Frame

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

Title

Area under the curve (AUC) of serum nonesterified fatty acid (NEFA) levels

Description

AUC of serum NEFA levels during MMTT

Time Frame

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

Title

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

Description

AUC of plasma active GLP-1 levels during MMTT

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Area under the curve (AUC) of plasma paracetamol levels

Description

AUC of plasma paracetamol levels during MMTT

Time Frame

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

Title

The peak concentration of plasma paracetamol

Description

The peak concentration of plasma paracetamol during MMTT

Time Frame

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

Title

The time to peak concentration of plasma paracetamol

Description

The time to peak concentration of plasma paracetamol during MMTT

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Young Min Cho, MD, PHD

Organizational Affiliation

Seoul National University College of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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