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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-2641 | Other Identifier | SNUH Institutional Review Board |
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| Name | Class |
|---|---|
| Daewoong Pharmaceutical Co. LTD. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mosapride | Experimental |
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| Control | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of plasma total GIP levels | AUC of plasma total GIP levels during MMTT | 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured) |
| Area under the curve (AUC) of plasma glucose levels |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of plasma paracetamol levels | AUC of plasma paracetamol levels during MMTT | 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured) |
| The peak concentration of plasma paracetamol |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young Min Cho, MD, PHD | Seoul National University College of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C062720 | mosapride |
| D000069476 | Linagliptin |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 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. |
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| 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). |
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AUC of plasma glucose levels during MMTT
| 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 | 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 | 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 | 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 | 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 | 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured) |
The peak concentration of plasma paracetamol during MMTT
| 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured) |
| The time to peak concentration of plasma paracetamol | The time to peak concentration of plasma paracetamol during MMTT | 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured) |
| D011799 | Quinazolines |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |