TIME-TG study

JRCT ID: jRCTs051200098

Registered date:17/12/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Type2 Diabetes
• Date of first enrollment: 01/07/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Comparison of pre- and post-prandial administration of anagliptin/metformin combination tablets on postprandial hypertriglyceridemia

Outcome(s)

• Primary Outcome: Change in area under the curve of postprandial triglyceride during 4h after a cookie loading test

Secondary Outcome

1.Differences of following variables between administration of anagliptin/metformin combination tablets before and after a cookie loading test
The maximum serum triglyceride concentration
The area under the curve of postprandial ApoB48,glucose, insulin, active GLP-1 and glucagon during a cookie loading test for 4 hours
The maximum serum ApoB48, glucose, insulin, active GLP-1 and glucagon concentration
2.Differences of following variables between administration of anagliptin/metformin combination tablets before and after 13C Acetate loading test
The time until the maximum ratio of change of 13CO2/12CO2 ratio in the breath (Time of peak 13CO2 excretion: Tmax)
The time when half of the total intake of 13C is excreted in the breath (half-emptying time: T1/2)
Gastric emptying coefficient(GEC)
3.Differences of following variables between pre- and post-prandial anagliptin/metformin combination tablets in continuous glucose monitoring system
Average glucose concentration
Mean amplitude of glucose excursion (MAGE)
Time in range (Blood glucose levels 70-180mg/dL)
Time below range (Blood glucose levels <70mg/dL)
Time above range (Blood glucose levels >180mg/dL)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 74age old
• Gender: Both

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Murata Koichiro
• Source(s) of Monetary Support: Sanwa Kagaku Kenkyusho CO., LTD.