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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
12
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.
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.
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).
Seoul National University Hospital
Seoul, South Korea
Area under the curve (AUC) of plasma total GLP-1 levels
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)
Area under the curve (AUC) of plasma total GIP levels
AUC of plasma total GIP levels during MMTT
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
AUC of plasma glucose levels during MMTT
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
AUC of plasma insulin levels during MMTT
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
AUC of plasma C-peptide levels during MMTT
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
AUC of serum triglyceride levels during MMTT
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
AUC of serum NEFA levels during MMTT
Time frame: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
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Area under the curve (AUC) of plasma active GLP-1 levels
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)