Diabetes Mellitus, Type 2Phase 4NCT02180334
The Effect of Combination of Mosapride and DPP-4 Inhibitor on Plasma Concentration of Incretin Hormones
A Phase 4 study testing Mosapride citrate, Linagliptin and Acetaminophen (paracetamol) in people with Diabetes Mellitus, Type 2, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Mosapride citrate, Linagliptin and Acetaminophen (paracetamol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Combination of Mosapride and Dipeptidyl Peptidase-4 (DPP-4) Inhibitor on Plasma Concentration of Incretin Hormones
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Mosapride citrate, Linagliptin, Acetaminophen (paracetamol)
- Keywords
- Gastric Emptying, Gastrointestinal Motility, Incretins, Glucagon-Like Peptide 1, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mosapride citrateDrug
Also called Gasmotin®
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.
LinagliptinDrug
Also called Trajenta®
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.
Acetaminophen (paracetamol)Drug
Also called Tylenol®
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Linagliptin; Drug: Acetaminophen (paracetamol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of plasma total GLP-1 levels
AUC of plasma total GLP-1 levels during MMTT
Measured: 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
AUC of plasma total GIP levels during MMTT
Measured: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
Area under the curve (AUC) of plasma glucose levels
AUC of plasma glucose levels during MMTT
Measured: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
Area under the curve (AUC) of plasma insulin levels
AUC of plasma insulin levels during MMTT
Measured: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
Area under the curve (AUC) of plasma C-peptide levels
AUC of plasma C-peptide levels during MMTT
Measured: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
Area under the curve (AUC) of serum triglyceride levels
AUC of serum triglyceride levels during MMTT
Measured: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
Area under the curve (AUC) of serum nonesterified fatty acid (NEFA) levels
AUC of serum NEFA levels during MMTT
Measured: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
Area under the curve (AUC) of plasma active GLP-1 levels
AUC of plasma active GLP-1 levels during MMTT
Measured: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Responsible party
- Sponsor
- Investigators
- Young Min Cho, MD, PHD, Study chair, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180334
- Sponsor's protocol ID
- H-1311-104-537
- Other IDs
- 2013-2641
- Status last verified
- Jun 2014
- First submitted
- 30 Jun 2014
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combination of Mosapride and Dipeptidyl Peptidase-4 (DPP-4) Inhibitor on Plasma Concentration of Incretin Hormones
- ClinicalTrials.gov ID
- NCT02180334
- Acronym / sponsor ID
- H-1311-104-537
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Gastric Emptying, Gastrointestinal Motility, Incretins, Glucagon-Like Peptide 1, Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Study start
- Jul 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mosapride | Experimental | Drug: Mosapride citrate, Drug: Linagliptin, Drug: Acetaminophen (paracetamol)* 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. |
| Control | Placebo comparator | Drug: Linagliptin, Drug: Acetaminophen (paracetamol)* 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mosapride citrateAlso: Gasmotin®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. | Drug | Mosapride |
| LinagliptinAlso: Trajenta®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. | Drug | Control, Mosapride |
| Acetaminophen (paracetamol)Also: Tylenol®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). | Drug | Control, Mosapride |
Primary outcome
Area under the curve (AUC) of plasma total GLP-1 levels
Time frame: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
AUC of plasma total GLP-1 levels during MMTT
7 secondary outcomes
Area under the curve (AUC) of plasma total GIP levels
Time frame: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
Area under the curve (AUC) of plasma glucose levels
Time frame: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
Area under the curve (AUC) of plasma insulin levels
Time frame: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
Area under the curve (AUC) of plasma C-peptide levels
Time frame: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
Area under the curve (AUC) of serum triglyceride levels
Time frame: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
Area under the curve (AUC) of serum nonesterified fatty acid (NEFA) levels
Time frame: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
Area under the curve (AUC) of plasma active GLP-1 levels
Time frame: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Min Cho, MD, PHD study chair
Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mosapride citrate, Linagliptin and Acetaminophen (paracetamol) in people with Diabetes Mellitus, Type 2, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) of plasma total GLP-1 levels (time frame: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.