TIME-TG study
- Conditions
- Type2 Diabetes
- Registration Number
- JPRN-jRCTs051200098
- Lead Sponsor
- Murata Koichiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
1. In-patients with type 2 diabetes mellitus who needed to be treated with oral diabetic medication
2. Over 20 and less than 75 years of age at the time of informed consent acquisition.
3. Patients whose pre-prandial blood glucose levels is less than 140mg/dl and post-prandial blood glucose (2 hours after meal) is less than 200 mg/dl at the time of registration.
4. Patients whose casual serum triglyceride level is not less than 200 and less than 1000 mg/dl.
5. Patients who are under metformin treatment with 1000 mg/day at the time of registration
6. Patients who received explanation of the research using an informed consent form and gave written consent on research participation.
1.Patients treated with medications affecting gastrointestinal motility (e.g., GLP-1 receptor agonists, alpha-glucosidase inhibitors and anticholinergic drugs)
2.Patients with a history of pancreatitis
3.Patients with severe autonomic neuropathy (e.g., orthostatic hypotension, neurogenic bladder, and coefficient of variation of R-R interval less than 1%)
4.Patients with a history of severe intestinal adhesions after upper gastrointestinal, hepatobiliary and pancreatic surgery
5.Patients whose estimated glomerular filtration rates less than 45 ml/min/1.73 m2
6.Patients treated with ultra-rapid or rapid insulin analogues.
7.Patients corresponding to the contraindication of anagliptin or metformin
8.Patients with current treatment for malignancy
9.Female patients during pregnancy or breastfeeding
10.Patients deemed inappropriate to participate in th research by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in area under the curve of postprandial triglyceride during 4h after a cookie loading test
- Secondary Outcome Measures
Name Time Method