The Effect of Combination of Mosapride and Dipeptidyl Peptidase-4 (DPP-4) Inhibitor on Plasma Concentration of Incretin Hormones
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC) of plasma total GLP-1 levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mosapride
- 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.
干预措施: Mosapride citrate (Drug)
Mosapride
- 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.
干预措施: Linagliptin (Drug)
Mosapride
- 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.
干预措施: Acetaminophen (paracetamol) (Drug)
Control
- 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.
干预措施: Linagliptin (Drug)
Control
- 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.
干预措施: Acetaminophen (paracetamol) (Drug)
结局指标
主要结局
Area under the curve (AUC) of plasma total GLP-1 levels
时间窗: 0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured)
AUC of plasma total GLP-1 levels during MMTT
次要结局
- 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 total GIP 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))
- Area under the curve (AUC) of plasma active GLP-1 levels(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(0, 15, 30, 60, 90, 120, 150, 180 min after taking mixed meal (manufactured))