Study of the effect of Anagliptin administration on the activity of glucagon after test meal loading

Not Applicable

• Conditions: Patients with type II diabetes mellitus

• Registration Number: JPRN-UMIN000021102
• Lead Sponsor: Arc Cardiovascular Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-01
• Study Completion: 2018-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with a history of hypersensitivity to the components of Anagliptin 2) Patients with severe ketosis, diabetic coma or pre-coma, or type I diabetes mellitus 3) Patients with severe infection or severe trauma, and pre- or post-operative patients 4) Patients with severe renal impairment or on dialysis with end-stage renal failure 5) Patients with a history of abdominal surgery (limited to gastrointestinal surgery) or intestinal obstruction 6) Women who are currently pregnant or may be pregnant, or women who are currently breastfeeding 7) Patients who are currently on continual insulin preparations or have been determined to require insulin preparations 8) Patients who are currently using GLP-1 receptor agonist medication or have been determined to require GLP-1 receptor agonist medication 9) Patients who may have allergy to wheat or eggs 10) Patients who may have difficulty conducting the test meal loading (no alcohol the previous day, 10 hours fasting, etc.) 11) Patients determined to be unsuitable for participation in the study by the research investigators or sub-investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in glucagon AUC0-2h during test meal loading one month after Anagliptin administration

Secondary Outcome Measures

Name	Time	Method
Change in all types of parameters during test meal loading before and after Anagliptin administration. (1)Glucagon level (fasting, 30 min, 60 min, 120 min, incremental AUC0-2h) (2)Blood glucose level (fasting, 30 min, 60 min, 120 min, incremental AUC0-2h, AUC0-2h) (3)Insulin level (fasting, 30 min, 60 min, 120 min, incremental AUC0-2h, AUC0-2h) (4)C-peptide (fasting, delta 0-30 min, incremental AUC0-1h, incremental AUC0-2h) (5)Insulin/glucagon ratio Changes in laboratory test results before and after Anagliptin administration AST(GOT), ALT(GPT), gamma-GTP, serum creatinine, total cholesterol, LDL-cholesterol (formula), HDL-cholesterol, triglyceride, HbA1c